Data page

General information

Jurisdiction	ID	country	Var_order	Variables	Data
EU	1	Austria	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Austrian Federal Office for Safety in Health Care (BASG)
EU	1	Austria	2	Link to the authority website	https://www.basg.gv.at/en/
EU	1	Austria	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.basg.gv.at/en/healthcare-professionals/clinical-trials/clinical-trials-with-medical-devices
EU	1	Austria	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	5/25/2022
EU	1	Austria	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	1	Austria	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	1	Austria	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	1	Austria	8	Link to the website of the performance monitoring system	No
EU	1	Austria	9	Key performance indicators included in the performance monitoring system	No
EU	1	Austria	10	Language of submission	Local language & English
EU	2	Belgium	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Federal Agency for Medicines and Health Products – Belgium (FAMHP)
EU	2	Belgium	2	Link to the authority website	https://www.famhp.be/en
EU	2	Belgium	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%209.0_1.pdf
EU	2	Belgium	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/11/2024
EU	2	Belgium	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	2	Belgium	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	2	Belgium	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	2	Belgium	8	Link to the website of the performance monitoring system	No
EU	2	Belgium	9	Key performance indicators included in the performance monitoring system	No
EU	2	Belgium	10	Language of submission	Local language, English, Dutch and German
EU	3	Bulgaria	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Bulgarian Drug Agency, Ministry of Health (BDA)
EU	3	Bulgaria	2	Link to the authority website	https://www.bda.bg/en/
EU	3	Bulgaria	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.bda.bg/en/information-for-companies/114-medical-devices-category
EU	3	Bulgaria	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	3	Bulgaria	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	3	Bulgaria	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	3	Bulgaria	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	3	Bulgaria	8	Link to the website of the performance monitoring system	N/A
EU	3	Bulgaria	9	Key performance indicators included in the performance monitoring system	N/A
EU	3	Bulgaria	10	Language of submission	Local language & English
EU	4	Croatia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
EU	4	Croatia	2	Link to the authority website	https://www.halmed.hr/en/
EU	4	Croatia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.halmed.hr/O-HALMED-u/Sredisnje-eticko-povjerenstvo-SEP/Naputci-podnositeljima-zahtjeva/
EU	4	Croatia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	4	Croatia	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EU	4	Croatia	6	Link to the website of the database of pre-market clinical investigations of MDs	https://sep.halmed.hr/
EU	4	Croatia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	4	Croatia	8	Link to the website of the performance monitoring system	N/A
EU	4	Croatia	9	Key performance indicators included in the performance monitoring system	N/A
EU	4	Croatia	10	Language of submission	Local language only
EU	5	Cyprus	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Cyprus Medical Devices Competent Authority (CYMDA)
EU	5	Cyprus	2	Link to the authority website	https://www.moh.gov.cy/Moh/mphs/mphs.nsf/home2/home2?openform
EU	5	Cyprus	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.moh.gov.cy/moh/mphs/mphs.nsf/page23_en/page23_en?OpenDocument
EU	5	Cyprus	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/15/2020
EU	5	Cyprus	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	5	Cyprus	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	5	Cyprus	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	5	Cyprus	8	Link to the website of the performance monitoring system	N/A
EU	5	Cyprus	9	Key performance indicators included in the performance monitoring system	N/A
EU	5	Cyprus	10	Language of submission	Local language & English
EU	6	Czechia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	State Institute for Drug Control – Czech Republic (SÚKL)
EU	6	Czechia	2	Link to the authority website	https://www.sukl.eu/
EU	6	Czechia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.sukl.eu/medical-devices/podani-zadosti-o-povoleni-provedeni-klinicke-zkousky
EU	6	Czechia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/7/2015
EU	6	Czechia	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EU	6	Czechia	6	Link to the website of the database of pre-market clinical investigations of MDs	https://prehledy.sukl.cz/prehled_kh.html
EU	6	Czechia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	6	Czechia	8	Link to the website of the performance monitoring system	No
EU	6	Czechia	9	Key performance indicators included in the performance monitoring system	No
EU	6	Czechia	10	Language of submission	Local language & English
EU	7	Denmark	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Danish Medicines Agency (DMA / Laegemiddelstyrelsen)
EU	7	Denmark	2	Link to the authority website	https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations
EU	7	Denmark	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://laegemiddelstyrelsen.dk/en/devices/new-regulations/
EU	7	Denmark	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	6/22/2023
EU	7	Denmark	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	7	Denmark	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	7	Denmark	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	7	Denmark	8	Link to the website of the performance monitoring system	No
EU	7	Denmark	9	Key performance indicators included in the performance monitoring system	No
EU	7	Denmark	10	Language of submission	Local language & English
EU	8	Estonia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Estonian Health Board (Health Board)
EU	8	Estonia	2	Link to the authority website	https://www.terviseamet.ee/en/medical-devices/regulatory-controls
EU	8	Estonia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.terviseamet.ee/en/clinical-investigations-and-performance-studies
EU	8	Estonia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	8	Estonia	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	8	Estonia	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	8	Estonia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	8	Estonia	8	Link to the website of the performance monitoring system	No
EU	8	Estonia	9	Key performance indicators included in the performance monitoring system	No
EU	8	Estonia	10	Language of submission	Local language & English
EU	9	Finland	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Finnish Medicines Agency (Fimea)
EU	9	Finland	2	Link to the authority website	www.fimea.fi
EU	9	Finland	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://fimea.fi/en/medical-devices/investigations-with-devices
EU	9	Finland	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	9	Finland	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	9	Finland	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	9	Finland	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	9	Finland	8	Link to the website of the performance monitoring system	N/A
EU	9	Finland	9	Key performance indicators included in the performance monitoring system	N/A
EU	9	Finland	10	Language of submission	Local language, English & Swedish
EU	10	France	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Agence nationale de sécurité du médicament et des produits de santé (ANSM)
EU	10	France	2	Link to the authority website	Accueil - ANSM (sante.fr)
EU	10	France	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	Dispositifs médicaux - Demander une autorisation pour une inves - ANSM (sante.fr)
EU	10	France	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	2/13/2023
EU	10	France	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	10	France	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	10	France	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	10	France	8	Link to the website of the performance monitoring system	N/A
EU	10	France	9	Key performance indicators included in the performance monitoring system	N/A
EU	10	France	10	Language of submission	Local language & English
EU	11	Germany	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Federal Institute for Drugs and Medical Devices – Germany (BfArM)
EU	11	Germany	2	Link to the authority website	https://www.bfarm.de/EN/Home/_node.html
EU	11	Germany	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.bfarm.de/EN/Medical-devices/Tasks/Clinical-investigations-and-performance-studies/Clinical-investigations/Request-for-authorisation-kp/_node.html
EU	11	Germany	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	8/17/2022
EU	11	Germany	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EU	11	Germany	6	Link to the website of the database of pre-market clinical investigations of MDs	https://drks.de/search/de
EU	11	Germany	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	11	Germany	8	Link to the website of the performance monitoring system	N/A
EU	11	Germany	9	Key performance indicators included in the performance monitoring system	N/A
EU	11	Germany	10	Language of submission	Local language & English
EU	12	Greece	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Organization for Medicines – Greece (EOF)
EU	12	Greece	2	Link to the authority website	https://www.eof.gr/web/guest;jsessionid=481cac2bbf55496b479bb61f0bc1
EU	12	Greece	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.eof.gr/web/guest/clinical-md
EU	12	Greece	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	12	Greece	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	12	Greece	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	12	Greece	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	12	Greece	8	Link to the website of the performance monitoring system	No
EU	12	Greece	9	Key performance indicators included in the performance monitoring system	No
EU	12	Greece	10	Language of submission	Local language & English
EU	13	Hungary	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Institute of Pharmacy and Nutrition – Hungary (OGYÉI)
EU	13	Hungary	2	Link to the authority website	https://ogyei.gov.hu/main_page
EU	13	Hungary	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://ogyei.gov.hu/medical_devices/
EU	13	Hungary	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	11/20/2023
EU	13	Hungary	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	13	Hungary	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	13	Hungary	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	13	Hungary	8	Link to the website of the performance monitoring system	N/A
EU	13	Hungary	9	Key performance indicators included in the performance monitoring system	N/A
EU	13	Hungary	10	Language of submission	Local language & English
EU	14	Ireland	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Health Products Regulatory Authority – Ireland (HPRA)
EU	14	Ireland	2	Link to the authority website	www.hpra.ie
EU	14	Ireland	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.hpra.ie/homepage/medical-devices/regulatory-information/medical-devices-regulation/clinical-investigations
EU	14	Ireland	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	11/18/2022
EU	14	Ireland	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	14	Ireland	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	14	Ireland	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	14	Ireland	8	Link to the website of the performance monitoring system	No
EU	14	Ireland	9	Key performance indicators included in the performance monitoring system	No
EU	14	Ireland	10	Language of submission	Local language & English
EU	15	Italy	1	Authority in charge of managing the pre-market clinical investigations for medical devices	General Directorate of Medical Devices and Pharmaceutical Service – Italy (GDMDPS)
EU	15	Italy	2	Link to the authority website	https://www.salute.gov.it/portale/ministro/p4_5_2_4_1.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1153
EU	15	Italy	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.salute.gov.it/portale/moduliServizi/catalogoModuliServizi.jsp?lingua=italiano&label=servizionline&menu=ufficio&gruppoUfficioDir=DGDMF-UFFXIV&gruppoUfficio=ALL
EU	15	Italy	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	8/7/2024
EU	15	Italy	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	15	Italy	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	15	Italy	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	15	Italy	8	Link to the website of the performance monitoring system	No
EU	15	Italy	9	Key performance indicators included in the performance monitoring system	No
EU	15	Italy	10	Language of submission	Local language & English
EU	16	Latvia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	State Agency of Medicines of Latvia (SAMLV)
EU	16	Latvia	2	Link to the authority website	https://www.zva.gov.lv/en
EU	16	Latvia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.zva.gov.lv/en/industry/medical-device-manufacturers-authorized-representatives/clinical-investigations-and-performance-studies
EU	16	Latvia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	9/18/2023
EU	16	Latvia	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	16	Latvia	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	16	Latvia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	16	Latvia	8	Link to the website of the performance monitoring system	No
EU	16	Latvia	9	Key performance indicators included in the performance monitoring system	No
EU	16	Latvia	10	Language of submission	Local language & English
EU	17	Lithuania	1	Authority in charge of managing the pre-market clinical investigations for medical devices	State Health Care Accreditation Agency – Lithuania (VASPVT)
EU	17	Lithuania	2	Link to the authority website	https://vaspvt.lrv.lt/en/
EU	17	Lithuania	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://vaspvt.lrv.lt/lt/medicinos-priemones-pagal-es-direktyvas/registravimas/
EU	17	Lithuania	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	11/9/2023
EU	17	Lithuania	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	17	Lithuania	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	17	Lithuania	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	17	Lithuania	8	Link to the website of the performance monitoring system	N/A
EU	17	Lithuania	9	Key performance indicators included in the performance monitoring system	N/A
EU	17	Lithuania	10	Language of submission	Local language only
EU	18	Luxembourg	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Ministry of Health – Luxembourg (Gesondheetsministère)
EU	18	Luxembourg	2	Link to the authority website	https://msan.gouvernement.lu/en.html
EU	18	Luxembourg	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://sante.public.lu/fr/espace-professionnel/domaines/recherche-biomedicale/investigation-clinique-dispositifs-medicaux.html
EU	18	Luxembourg	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	10/20/2023
EU	18	Luxembourg	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	18	Luxembourg	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	18	Luxembourg	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	18	Luxembourg	8	Link to the website of the performance monitoring system	N/A
EU	18	Luxembourg	9	Key performance indicators included in the performance monitoring system	N/A
EU	18	Luxembourg	10	Language of submission	Local language, English & German
EU	19	Malta	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Malta Medicines Authority (MMA)
EU	19	Malta	2	Link to the authority website	https://medicinesauthority.gov.mt
EU	19	Malta	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	19	Malta	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	19	Malta	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	19	Malta	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	19	Malta	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	19	Malta	8	Link to the website of the performance monitoring system	N/A
EU	19	Malta	9	Key performance indicators included in the performance monitoring system	N/A
EU	19	Malta	10	Language of submission	Local language & English
EU	20	Netherlands	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Central Committee on Research Involving Human Subjects – Netherlands (CCMO)
EU	20	Netherlands	2	Link to the authority website	https://english.ccmo.nl/
EU	20	Netherlands	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices
EU	20	Netherlands	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	3/1/2021
EU	20	Netherlands	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EU	20	Netherlands	6	Link to the website of the database of pre-market clinical investigations of MDs	https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm https://onderzoekmetmensen.nl/nl
EU	20	Netherlands	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EU	20	Netherlands	8	Link to the website of the performance monitoring system	No
EU	20	Netherlands	9	Key performance indicators included in the performance monitoring system	No
EU	20	Netherlands	10	Language of submission	Local language & English
EU	21	Poland	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Poland (URPL)
EU	21	Poland	2	Link to the authority website	https://www.urpl.gov.pl/
EU	21	Poland	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.urpl.gov.pl/pl/wyroby-medyczne/badania-kliniczne-wyrob%C3%B3w-medycznych/dokumenty-za%C5%82%C4%85czane-do-wniosk%C3%B3w
EU	21	Poland	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/1/2015
EU	21	Poland	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	21	Poland	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	21	Poland	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	21	Poland	8	Link to the website of the performance monitoring system	N/A
EU	21	Poland	9	Key performance indicators included in the performance monitoring system	N/A
EU	21	Poland	10	Language of submission	Local language & English (some documents)
EU	22	Portugal	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Authority of Medicines and Health Products – Portugal (INFARMED)
EU	22	Portugal	2	Link to the authority website	https://www.infarmed.pt/
EU	22	Portugal	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos/investigacao-clinica-avaliacao-funcional/dm_meio_clinico_humano_adequado
EU	22	Portugal	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/1/2016
EU	22	Portugal	5	Existence of a public database of pre-market clinical investigations of MDs	No
EU	22	Portugal	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EU	22	Portugal	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
EU	22	Portugal	8	Link to the website of the performance monitoring system	https://www.infarmed.pt/web/infarmed/institucional/documentacao_e_informacao/documentos-institucionais#tab3
EU	22	Portugal	9	Key performance indicators included in the performance monitoring system	Yes
EU	22	Portugal	10	Language of submission	Local language & English
EU	23	Romania	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Agency for Medicines and Medical Devices – Romania (NAMMDR)
EU	23	Romania	2	Link to the authority website	https://www.anm.ro/en/dispozitive-medicale/
EU	23	Romania	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.anm.ro/en/dispozitive-medicale/investigatie-clinica/
EU	23	Romania	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	23	Romania	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	23	Romania	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	23	Romania	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	23	Romania	8	Link to the website of the performance monitoring system	N/A
EU	23	Romania	9	Key performance indicators included in the performance monitoring system	N/A
EU	23	Romania	10	Language of submission	N/A
EU	24	Slovakia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	State Institute for Drug Control – Slovak Republic (_ÚKL)
EU	24	Slovakia	2	Link to the authority website	https://www.sukl.sk/
EU	24	Slovakia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.sukl.sk/sk/zdravotnicke-pomocky-informacie/informacie-tykajuce-sa-trhoveho-dohladu-vigilancie-a-klinickeho-skusania?page_id=5699
EU	24	Slovakia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	24	Slovakia	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	24	Slovakia	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	24	Slovakia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	24	Slovakia	8	Link to the website of the performance monitoring system	N/A
EU	24	Slovakia	9	Key performance indicators included in the performance monitoring system	N/A
EU	24	Slovakia	10	Language of submission	Local language only
EU	25	Slovenia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Agency for Medicinal Products and Medical Devices of Slovenia (JAZMP)
EU	25	Slovenia	2	Link to the authority website	https://www.jazmp.si/en/
EU	25	Slovenia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.jazmp.si/en/medical-devices/clinical-investigations/
EU	25	Slovenia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EU	25	Slovenia	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	25	Slovenia	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	25	Slovenia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	25	Slovenia	8	Link to the website of the performance monitoring system	N/A
EU	25	Slovenia	9	Key performance indicators included in the performance monitoring system	N/A
EU	25	Slovenia	10	Language of submission	N/A
EU	26	Spain	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Spanish Agency of Medicines and Medical Devices (AEMPS)
EU	26	Spain	2	Link to the authority website	https://www.aemps.gob.es/
EU	26	Spain	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	Investigaciones clínicas con productos sanitarios \| Agencia Española de Medicamentos y Productos Sanitarios (aemps.gob.es)
EU	26	Spain	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/30/2023
EU	26	Spain	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	26	Spain	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	26	Spain	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	26	Spain	8	Link to the website of the performance monitoring system	N/A
EU	26	Spain	9	Key performance indicators included in the performance monitoring system	N/A
EU	26	Spain	10	Language of submission	Local language & English (some documents)
EU	27	Sweden	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Swedish Medical Products Agency (MPA)
EU	27	Sweden	2	Link to the authority website	https://www.lakemedelsverket.se/en
EU	27	Sweden	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.lakemedelsverket.se/en/permission-approval-and-control/clinical-trials/medical-devices/clinical-investigation-of-medical-device
EU	27	Sweden	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	5/12/2022
EU	27	Sweden	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EU	27	Sweden	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EU	27	Sweden	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EU	27	Sweden	8	Link to the website of the performance monitoring system	N/A
EU	27	Sweden	9	Key performance indicators included in the performance monitoring system	N/A
EU	27	Sweden	10	Language of submission	Local language & English
EEA	28	Iceland	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Icelandic Medicines Agency (IMA / Lyfjastofnun)
EEA	28	Iceland	2	Link to the authority website	https://www.ima.is/
EEA	28	Iceland	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.lyfjastofnun.is/laekningataeki/kliniskar-profanir-a-laekningataekjum/
EEA	28	Iceland	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/20/2023
EEA	28	Iceland	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EEA	28	Iceland	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EEA	28	Iceland	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EEA	28	Iceland	8	Link to the website of the performance monitoring system	N/A
EEA	28	Iceland	9	Key performance indicators included in the performance monitoring system	N/A
EEA	28	Iceland	10	Language of submission	Local language & English
EEA	29	Liechtenstein	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Office of Public Health – Principality of Liechtenstein (Amt für Gesundheit)
EEA	29	Liechtenstein	2	Link to the authority website	https://www.llv.li/en/national-administration/office-of-public-health
EEA	29	Liechtenstein	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.llv.li/en/company/industry-professional-associations/health-professions-and-healing/medical-devices-in-vitro-diagnostics/clinical-exams
EEA	29	Liechtenstein	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/1/2023
EEA	29	Liechtenstein	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EEA	29	Liechtenstein	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EEA	29	Liechtenstein	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EEA	29	Liechtenstein	8	Link to the website of the performance monitoring system	N/A
EEA	29	Liechtenstein	9	Key performance indicators included in the performance monitoring system	N/A
EEA	29	Liechtenstein	10	Language of submission	Local language & English
EEA	30	Norway	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Norwegian Medical Products Agency (NoMA)
EEA	30	Norway	2	Link to the authority website	https://www.dmp.no/en
EEA	30	Norway	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.dmp.no/en/medical-devices/clinical-investigation-of-medical-devices
EEA	30	Norway	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	10/5/2023
EEA	30	Norway	5	Existence of a public database of pre-market clinical investigations of MDs	No
EEA	30	Norway	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EEA	30	Norway	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EEA	30	Norway	8	Link to the website of the performance monitoring system	No
EEA	30	Norway	9	Key performance indicators included in the performance monitoring system	No
EEA	30	Norway	10	Language of submission	Local language & English
EMEA	31	Albania	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Agency for Medicines and Medical Devices – Albania (AKBPM)
EMEA	31	Albania	2	Link to the authority website	https://akbpm.gov.al/
EMEA	31	Albania	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	ther's no section dedicated to pre market clinical investigation of MDs
EMEA	31	Albania	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EMEA	31	Albania	5	Existence of a public database of pre-market clinical investigations of MDs	No
EMEA	31	Albania	6	Link to the website of the database of pre-market clinical investigations of MDs	there is no database of pre-market clinical trials there is a database of all medical devices that is not published on the website by the Competent Authority
EMEA	31	Albania	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EMEA	31	Albania	8	Link to the website of the performance monitoring system	No
EMEA	31	Albania	9	Key performance indicators included in the performance monitoring system	No
EMEA	31	Albania	10	Language of submission	Local language only
EMEA	32	Georgia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Ministry of Health – Georgia (MoH Georgia)
EMEA	32	Georgia	2	Link to the authority website	https://www.moh.gov.ge/law.php?uid=202308172104117935768264&lang=1&uid=202308172104117935768264
EMEA	32	Georgia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.moh.gov.ge/docs/20231206115504-10.pdf
EMEA	32	Georgia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EMEA	32	Georgia	5	Existence of a public database of pre-market clinical investigations of MDs	No
EMEA	32	Georgia	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EMEA	32	Georgia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	32	Georgia	8	Link to the website of the performance monitoring system	N/A
EMEA	32	Georgia	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	32	Georgia	10	Language of submission	Local language & English (some documents)
EMEA	33	Israel	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Ministry of Health (MOH)
EMEA	33	Israel	2	Link to the authority website	https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/MLD/Pages/default.aspx
EMEA	33	Israel	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.gov.il/he/departments/general/clinical-trials-medical-devices
EMEA	33	Israel	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	3/2/2023
EMEA	33	Israel	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EMEA	33	Israel	6	Link to the website of the database of pre-market clinical investigations of MDs	https://my.health.gov.il/CliniTrials/Pages/Home.aspx
EMEA	33	Israel	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	33	Israel	8	Link to the website of the performance monitoring system	N/A
EMEA	33	Israel	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	33	Israel	10	Language of submission	Local language & English (some documents)
EMEA	34	Kazakhstan	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Ministry of Healthcare of the Republic of Kazakhstan
EMEA	34	Kazakhstan	2	Link to the authority website	https://www.gov.kz/memleket/entities/dsm?lang=en
EMEA	34	Kazakhstan	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.ndda.kz/category/inspekciya_mi
EMEA	34	Kazakhstan	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	6/14/2021
EMEA	34	Kazakhstan	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EMEA	34	Kazakhstan	6	Link to the website of the database of pre-market clinical investigations of MDs	http://register.ndda.kz/category/search_prep
EMEA	34	Kazakhstan	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	34	Kazakhstan	8	Link to the website of the performance monitoring system	N/A
EMEA	34	Kazakhstan	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	34	Kazakhstan	10	Language of submission	Local language & Russian
EMEA	35	Russia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Federal Service for Surveillance in Healthcare – Russian Federation (Roszdravnadzor)
EMEA	35	Russia	2	Link to the authority website	1) https://roszdravnadzor.gov.ru/ 2) https://minzdrav.gov.ru/
EMEA	35	Russia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.ndda.kz/pages/5200
EMEA	35	Russia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EMEA	35	Russia	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EMEA	35	Russia	6	Link to the website of the database of pre-market clinical investigations of MDs	We have link only to approved clinical studies in Russia: https://roszdravnadzor.gov.ru/services/clinic
EMEA	35	Russia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EMEA	35	Russia	8	Link to the website of the performance monitoring system	No
EMEA	35	Russia	9	Key performance indicators included in the performance monitoring system	No
EMEA	35	Russia	10	Language of submission	Local language only
EMEA	36	Saudi Arabia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Saudi Food and Drug Authority (SFDA)
EMEA	36	Saudi Arabia	2	Link to the authority website	https://www.sfda.gov.sa/en
EMEA	36	Saudi Arabia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://sfda.gov.sa/en/regulations/66129
EMEA	36	Saudi Arabia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/19/2023
EMEA	36	Saudi Arabia	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EMEA	36	Saudi Arabia	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EMEA	36	Saudi Arabia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	36	Saudi Arabia	8	Link to the website of the performance monitoring system	N/A
EMEA	36	Saudi Arabia	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	36	Saudi Arabia	10	Language of submission	Local language & English
EMEA	37	South Africa	1	Authority in charge of managing the pre-market clinical investigations for medical devices	South African Health Products Regulatory Authority (SAHPRA)
EMEA	37	South Africa	2	Link to the authority website	https://www.sahpra.org.za/
EMEA	37	South Africa	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.sahpra.org.za/clinical-trials/
EMEA	37	South Africa	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EMEA	37	South Africa	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EMEA	37	South Africa	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EMEA	37	South Africa	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	37	South Africa	8	Link to the website of the performance monitoring system	N/A
EMEA	37	South Africa	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	37	South Africa	10	Language of submission	Local language & English
EMEA	38	Switzerland	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Swiss Agency for Therapeutic Products (Swissmedic)
EMEA	38	Switzerland	2	Link to the authority website	https://www.swissmedic.ch/swissmedic/en/home.html
EMEA	38	Switzerland	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/klinische-pruefungen.html www.swissmedic.ch/ clinical-investigations-en
EMEA	38	Switzerland	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/1/2023
EMEA	38	Switzerland	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EMEA	38	Switzerland	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EMEA	38	Switzerland	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
EMEA	38	Switzerland	8	Link to the website of the performance monitoring system	No
EMEA	38	Switzerland	9	Key performance indicators included in the performance monitoring system	No
EMEA	38	Switzerland	10	Language of submission	Local language & English (some documents)
EMEA	39	Tunisia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Directorate of Pharmacy and Medicines – Tunisia (DPM)
EMEA	39	Tunisia	2	Link to the authority website	http://www.dpm.tn/
EMEA	39	Tunisia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	No
EMEA	39	Tunisia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
EMEA	39	Tunisia	5	Existence of a public database of pre-market clinical investigations of MDs	No
EMEA	39	Tunisia	6	Link to the website of the database of pre-market clinical investigations of MDs	No
EMEA	39	Tunisia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	39	Tunisia	8	Link to the website of the performance monitoring system	N/A
EMEA	39	Tunisia	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	39	Tunisia	10	Language of submission	N/A
EMEA	40	Turkey	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Turkish Medicines and Medical Devices Agency (T_TCK)
EMEA	40	Turkey	2	Link to the authority website	https://www.titck.gov.tr/
EMEA	40	Turkey	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/55
EMEA	40	Turkey	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	9/9/2024
EMEA	40	Turkey	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
EMEA	40	Turkey	6	Link to the website of the database of pre-market clinical investigations of MDs	https://ebs.titck.gov.tr/Public/KapNormalArama
EMEA	40	Turkey	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
EMEA	40	Turkey	8	Link to the website of the performance monitoring system	NA
EMEA	40	Turkey	9	Key performance indicators included in the performance monitoring system	Rate of compliance with the assessment deadlines specified in the Regulation which is fully compliance with EU MDR
EMEA	40	Turkey	10	Language of submission	Local language & English
EMEA	41	UK	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Medicines and Healthcare products Regulatory Agency – United Kingdom (MHRA)
EMEA	41	UK	2	Link to the authority website	https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
EMEA	41	UK	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#legislation-that-applies-in-great-britain
EMEA	41	UK	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	7/20/2023
EMEA	41	UK	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
EMEA	41	UK	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
EMEA	41	UK	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
EMEA	41	UK	8	Link to the website of the performance monitoring system	N/A
EMEA	41	UK	9	Key performance indicators included in the performance monitoring system	N/A
EMEA	41	UK	10	Language of submission	Local language only
NAFTA	42	Canada	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Health Canada (HC)
NAFTA	42	Canada	2	Link to the authority website	https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices
NAFTA	42	Canada	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html
NAFTA	42	Canada	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	10/1/2018
NAFTA	42	Canada	5	Existence of a public database of pre-market clinical investigations of MDs	No
NAFTA	42	Canada	6	Link to the website of the database of pre-market clinical investigations of MDs	No
NAFTA	42	Canada	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
NAFTA	42	Canada	8	Link to the website of the performance monitoring system	Only made available to trade associations
NAFTA	42	Canada	9	Key performance indicators included in the performance monitoring system	Limited target regarding review cycles
NAFTA	42	Canada	10	Language of submission	Local language only
NAFTA	43	USA	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Food and Drug Administration – United States (with local IRB) (FDA)
NAFTA	43	USA	2	Link to the authority website	www.fda.gov
NAFTA	43	USA	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application
NAFTA	43	USA	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	10/3/2022
NAFTA	43	USA	5	Existence of a public database of pre-market clinical investigations of MDs	No
NAFTA	43	USA	6	Link to the website of the database of pre-market clinical investigations of MDs	No
NAFTA	43	USA	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
NAFTA	43	USA	8	Link to the website of the performance monitoring system	https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports
NAFTA	43	USA	9	Key performance indicators included in the performance monitoring system	Yes
NAFTA	43	USA	10	Language of submission	Local language only
LATAM	44	Argentina	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Administration of Drugs, Foods and Medical Devices – Argentina (ANMAT)
LATAM	44	Argentina	2	Link to the authority website	https://www.argentina.gob.ar/anmat
LATAM	44	Argentina	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.argentina.gob.ar/salud/registroinvestigaciones
LATAM	44	Argentina	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
LATAM	44	Argentina	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
LATAM	44	Argentina	6	Link to the website of the database of pre-market clinical investigations of MDs	https://sisa.msal.gov.ar/sisa/#sisa (Includes not only medical device)
LATAM	44	Argentina	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
LATAM	44	Argentina	8	Link to the website of the performance monitoring system	No
LATAM	44	Argentina	9	Key performance indicators included in the performance monitoring system	No
LATAM	44	Argentina	10	Language of submission	Local language & English
LATAM	45	Brazil	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Brazilian Health Regulatory Agency (ANVISA)
LATAM	45	Brazil	2	Link to the authority website	https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices
LATAM	45	Brazil	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/pesquisa-clinica/ensaios-clinicos-autorizados-e-indeferidos
LATAM	45	Brazil	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	6/16/2023
LATAM	45	Brazil	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
LATAM	45	Brazil	6	Link to the website of the database of pre-market clinical investigations of MDs	https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/pesquisa-clinica/ensaios-clinicos-autorizados-e-indeferidos/ensaios-clinicos-envolvendo-dispositivos-medicos-autorizados-indeferidos-pela-anvisa-dicd.pdf/view (for class III a
LATAM	45	Brazil	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
LATAM	45	Brazil	8	Link to the website of the performance monitoring system	https://conselho.saude.gov.br/plataforma-brasil-conep?view=default (enter in Brasil platform website section)
LATAM	45	Brazil	9	Key performance indicators included in the performance monitoring system	· Total users registered. · Total users registered in 2023. · Total projects submitted. · Total projects submitted in 2023. · Total institutions registered.
LATAM	45	Brazil	10	Language of submission	Local language & English
LATAM	46	Chile	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Institute of Public Health – Chile (ISP)
LATAM	46	Chile	2	Link to the authority website	https://www.ispch.gob.cl/
LATAM	46	Chile	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://giconaweb.ispch.gob.cl/
LATAM	46	Chile	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
LATAM	46	Chile	5	Existence of a public database of pre-market clinical investigations of MDs	No
LATAM	46	Chile	6	Link to the website of the database of pre-market clinical investigations of MDs	No
LATAM	46	Chile	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
LATAM	46	Chile	8	Link to the website of the performance monitoring system	No
LATAM	46	Chile	9	Key performance indicators included in the performance monitoring system	No
LATAM	46	Chile	10	Language of submission	Local language & English
LATAM	47	Colombia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Institute for Food and Drug Surveillance – Colombia (INVIMA)
LATAM	47	Colombia	2	Link to the authority website	https://www.invima.gov.co/
LATAM	47	Colombia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/dispositivos-medicos-y-equipos-biomedicos
LATAM	47	Colombia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	11/1/2023
LATAM	47	Colombia	5	Existence of a public database of pre-market clinical investigations of MDs	No
LATAM	47	Colombia	6	Link to the website of the database of pre-market clinical investigations of MDs	No
LATAM	47	Colombia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
LATAM	47	Colombia	8	Link to the website of the performance monitoring system	No
LATAM	47	Colombia	9	Key performance indicators included in the performance monitoring system	No
LATAM	47	Colombia	10	Language of submission	Local language only
LATAM	48	Paraguay	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Directorate of Health Surveillance – Paraguay (DINAVISA)
LATAM	48	Paraguay	2	Link to the authority website	https://www.mspbs.gov.py/dnvs
LATAM	48	Paraguay	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://dinavisa.gov.py/direccion-de-investigacion/
LATAM	48	Paraguay	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
LATAM	48	Paraguay	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
LATAM	48	Paraguay	6	Link to the website of the database of pre-market clinical investigations of MDs	https://dinavisa.gov.py/wp-content/uploads/2023/09/Ensayos-Clinicos-Autorizados.pdf
LATAM	48	Paraguay	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
LATAM	48	Paraguay	8	Link to the website of the performance monitoring system	No
LATAM	48	Paraguay	9	Key performance indicators included in the performance monitoring system	No
LATAM	48	Paraguay	10	Language of submission	Local language, English & other languages (if translated)
APAC	49	Australia	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Therapeutic Goods Administration – Australia (TGA)
APAC	49	Australia	2	Link to the authority website	https://www.tga.gov.au/
APAC	49	Australia	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.tga.gov.au/clinical-trials
APAC	49	Australia	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	5/23/2022
APAC	49	Australia	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
APAC	49	Australia	6	Link to the website of the database of pre-market clinical investigations of MDs	https://www.anzctr.org.au/
APAC	49	Australia	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	Yes
APAC	49	Australia	8	Link to the website of the performance monitoring system	https://www.tga.gov.au/news/news/proactive-monitoring-highest-risk-medical-device-clinical-trials
APAC	49	Australia	9	Key performance indicators included in the performance monitoring system	risk-based Good Clinical Practice (GCP) Inspection Program
APAC	49	Australia	10	Language of submission	Local language only
APAC	50	China	1	Authority in charge of managing the pre-market clinical investigations for medical devices	National Medical Products Administration – China (NMPA)
APAC	50	China	2	Link to the authority website	http://english.nmpa.gov.cn/index.html
APAC	50	China	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202100001
APAC	50	China	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
APAC	50	China	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
APAC	50	China	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
APAC	50	China	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	50	China	8	Link to the website of the performance monitoring system	N/A
APAC	50	China	9	Key performance indicators included in the performance monitoring system	N/A
APAC	50	China	10	Language of submission	Local language only
APAC	51	Japan	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Pharmaceuticals and Medical Devices Agency – Japan (PMDA)
APAC	51	Japan	2	Link to the authority website	https://www.pmda.go.jp/english/index.html
APAC	51	Japan	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	No
APAC	51	Japan	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
APAC	51	Japan	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
APAC	51	Japan	6	Link to the website of the database of pre-market clinical investigations of MDs	https://jrct.niph.go.jp/search?language=en
APAC	51	Japan	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	No
APAC	51	Japan	8	Link to the website of the performance monitoring system	No
APAC	51	Japan	9	Key performance indicators included in the performance monitoring system	No
APAC	51	Japan	10	Language of submission	Local language only
APAC	52	India	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Central Drugs Standard Control Organization – India (CDSCO)
APAC	52	India	2	Link to the authority website	https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
APAC	52	India	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/
APAC	52	India	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	1/1/2020
APAC	52	India	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
APAC	52	India	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
APAC	52	India	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	52	India	8	Link to the website of the performance monitoring system	N/A
APAC	52	India	9	Key performance indicators included in the performance monitoring system	N/A
APAC	52	India	10	Language of submission	Local language & English
APAC	53	New_Zealand	1	Authority in charge of managing the pre-market clinical investigations for medical devices	New Zealand Medicines and Medical Devices Safety Authority (Medsafe)
APAC	53	New_Zealand	2	Link to the authority website	https://medsafe.govt.nz/regulatory/devicesnew/13ConductingClinicalTrials.asp
APAC	53	New_Zealand	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://medsafe.govt.nz/regulatory/devicesnew/13ConductingClinicalTrials.asp
APAC	53	New_Zealand	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	10/5/2011
APAC	53	New_Zealand	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
APAC	53	New_Zealand	6	Link to the website of the database of pre-market clinical investigations of MDs	Australian New Zeasland Clinical Trials Registry (ANZCTR.org.au) ANZCTR"
APAC	53	New_Zealand	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	53	New_Zealand	8	Link to the website of the performance monitoring system	N/A
APAC	53	New_Zealand	9	Key performance indicators included in the performance monitoring system	N/A
APAC	53	New_Zealand	10	Language of submission	Local language only
APAC	54	Republic_of_Korea	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Ministry of Food and Drug Safety – South Korea (MFDS)
APAC	54	Republic_of_Korea	2	Link to the authority website	https://www.mfds.go.kr/eng/index.do
APAC	54	Republic_of_Korea	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	Clinical Trials (medsafe.govt.nz)
APAC	54	Republic_of_Korea	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	N/A
APAC	54	Republic_of_Korea	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
APAC	54	Republic_of_Korea	6	Link to the website of the database of pre-market clinical investigations of MDs	https://cris.nih.go.kr/cris/index/index.do
APAC	54	Republic_of_Korea	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	54	Republic_of_Korea	8	Link to the website of the performance monitoring system	N/A
APAC	54	Republic_of_Korea	9	Key performance indicators included in the performance monitoring system	N/A
APAC	54	Republic_of_Korea	10	Language of submission	Local language only
APAC	55	Taiwan	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Taiwan Food and Drug Administration (TFDA)
APAC	55	Taiwan	2	Link to the authority website	https://www.fda.gov.tw/eng/
APAC	55	Taiwan	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.fda.gov.tw/eng/siteList.aspx?sid=10337
APAC	55	Taiwan	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	9/30/2022
APAC	55	Taiwan	5	Existence of a public database of pre-market clinical investigations of MDs	Yes
APAC	55	Taiwan	6	Link to the website of the database of pre-market clinical investigations of MDs	https://mdctp.fda.gov.tw/#/
APAC	55	Taiwan	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	55	Taiwan	8	Link to the website of the performance monitoring system	N/A
APAC	55	Taiwan	9	Key performance indicators included in the performance monitoring system	N/A
APAC	55	Taiwan	10	Language of submission	Local language & English
APAC	56	Singapore	1	Authority in charge of managing the pre-market clinical investigations for medical devices	Health Sciences Authority – Singapore (HSA)
APAC	56	Singapore	2	Link to the authority website	https://www.hsa.gov.sg/
APAC	56	Singapore	3	Link to the section of the website dedicated to pre-market clinical investigations of MDs	https://www.hsa.gov.sg/medical-devices/clinical-trials
APAC	56	Singapore	4	Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs	12/18/2023
APAC	56	Singapore	5	Existence of a public database of pre-market clinical investigations of MDs	N/A
APAC	56	Singapore	6	Link to the website of the database of pre-market clinical investigations of MDs	N/A
APAC	56	Singapore	7	Existence of a performance monitoring system of the pre-market clinical investigations of MDs	N/A
APAC	56	Singapore	8	Link to the website of the performance monitoring system	N/A
APAC	56	Singapore	9	Key performance indicators included in the performance monitoring system	N/A
APAC	56	Singapore	10	Language of submission	Local language & English
Jurisdiction	ID	country	Var_order	Variables	Data

Detailed information on application procedures

ID	Group	Country	Jurisdiction	Code vars	Variables	Procedure
1	General	Austria	EU	1	Link to the website of the procedure	https://www.basg.gv.at/fileadmin/redakteure/01_Formulare_Listen/I/L_I99_Guidance_CI_MPG.pdf
1	Fee	Austria	EU	2	Fee (€)	7927
1	Standard documentation to be submitted	Austria	EU	3a	Cover letter	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3b	Authorisation/application form	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3c	Investigator's Brochure	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3f	Case Report Form (CRF)	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3h	Proof of insurance cover	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
1	Standard documentation to be submitted	Austria	EU	3j	Proof of payment of the fee	No
1	Standard documentation to be submitted	Austria	EU	3k	Opinion of experts’ panels	No
1	Standard documentation to be submitted	Austria	EU	3l	CE certificates of Notified Bodies	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3m	Decisions of other Competent Authorities concerned	No
1	Standard documentation to be submitted	Austria	EU	3n	Post Market Clinical Follow-up (PMCF) plan	No
1	Standard documentation to be submitted	Austria	EU	3o	Recruitment procedures and advertising materials	No
1	Standard documentation to be submitted	Austria	EU	3p	Opinion of other Ethics Committees concerned	No
1	Standard documentation to be submitted	Austria	EU	3q	General Device Information	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3r	Medicinal products contained in the device	N/A
1	Standard documentation to be submitted	Austria	EU	3s	List of participating countries	N/A
1	Standard documentation to be submitted	Austria	EU	3t	Trial centres list	N/A
1	Standard documentation to be submitted	Austria	EU	3u	Declaration of possession of requirements for trial centres	No
1	Standard documentation to be submitted	Austria	EU	3v	Compliance to ISO 14155	Yes, mandatory
1	Standard documentation to be submitted	Austria	EU	3w	MRI checklist	N/A
1	Standard documentation to be submitted	Austria	EU	3x	Ionising radiation information	N/A
1	Standard documentation to be submitted	Austria	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
1	Patients' involvement	Austria	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
1	Patients' involvement	Austria	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
1	Patients' involvement	Austria	EU	4b	Timing of patients’ involvement	N/A
1	HTA involvement	Austria	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
1	HTA involvement	Austria	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
1	HTA involvement	Austria	EU	5b	Timing of HTA bodies’ involvement	N/A
1	Expert involvement	Austria	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
1	Expert involvement	Austria	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
1	Expert involvement	Austria	EU	6b	Timing of expert panels’ involvement	N/A
1	Reimbursement	Austria	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
1	Reimbursement	Austria	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
2	General	Belgium	EU	1	Link to the website of the procedure	https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/clinical_evaluation/DM
2	Fee	Belgium	EU	2	Fee (€)	I/II 12466 III 18013 If dossiers are withdrawn or rejected 592
2	Standard documentation to be submitted	Belgium	EU	3a	Cover letter	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3b	Authorisation/application form	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3c	Investigator's Brochure	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3e	Copy of the opinion of the ethics committee	N/A
2	Standard documentation to be submitted	Belgium	EU	3f	Case Report Form (CRF)	N/A
2	Standard documentation to be submitted	Belgium	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3h	Proof of insurance cover	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3j	Proof of payment of the fee	N/A
2	Standard documentation to be submitted	Belgium	EU	3k	Opinion of experts’ panels	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3l	CE certificates of Notified Bodies	N/A
2	Standard documentation to be submitted	Belgium	EU	3m	Decisions of other Competent Authorities concerned	N/A
2	Standard documentation to be submitted	Belgium	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
2	Standard documentation to be submitted	Belgium	EU	3o	Recruitment procedures and advertising materials	N/A
2	Standard documentation to be submitted	Belgium	EU	3p	Opinion of other Ethics Committees concerned	N/A
2	Standard documentation to be submitted	Belgium	EU	3q	General Device Information	N/A
2	Standard documentation to be submitted	Belgium	EU	3r	Medicinal products contained in the device	N/A
2	Standard documentation to be submitted	Belgium	EU	3s	List of participating countries	N/A
2	Standard documentation to be submitted	Belgium	EU	3t	Trial centres list	Yes, mandatory
2	Standard documentation to be submitted	Belgium	EU	3u	Declaration of possession of requirements for trial centres	N/A
2	Standard documentation to be submitted	Belgium	EU	3v	Compliance to ISO 14155	N/A
2	Standard documentation to be submitted	Belgium	EU	3w	MRI checklist	N/A
2	Standard documentation to be submitted	Belgium	EU	3x	Ionising radiation information	N/A
2	Standard documentation to be submitted	Belgium	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
2	Patients' involvement	Belgium	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	Yes, mandatory
2	Patients' involvement	Belgium	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
2	Patients' involvement	Belgium	EU	4b	Timing of patients’ involvement	N/A
2	HTA involvement	Belgium	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	Yes, optional
2	HTA involvement	Belgium	EU	5a	Brief description of the type and extent of HTA bodies involvement	Proposals for research topics can be submitted by any individual, organisation or policy maker and KCI will assess the added value in terms of health compared to the cost for society
2	HTA involvement	Belgium	EU	5b	Timing of HTA bodies’ involvement	N/A
2	Expert involvement	Belgium	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
2	Expert involvement	Belgium	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
2	Expert involvement	Belgium	EU	6b	Timing of expert panels’ involvement	N/A
2	Reimbursement	Belgium	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	Yes, mandatory
2	Reimbursement	Belgium	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
3	General	Bulgaria	EU	1	Link to the website of the procedure	https://iisda.government.bg/adm_services/services/service_provision/6825
3	Fee	Bulgaria	EU	2	Fee (€)	1532
3	Standard documentation to be submitted	Bulgaria	EU	3a	Cover letter	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3b	Authorisation/application form	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3c	Investigator's Brochure	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3f	Case Report Form (CRF)	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3h	Proof of insurance cover	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3j	Proof of payment of the fee	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3k	Opinion of experts’ panels	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3l	CE certificates of Notified Bodies	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3m	Decisions of other Competent Authorities concerned	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3o	Recruitment procedures and advertising materials	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3p	Opinion of other Ethics Committees concerned	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3q	General Device Information	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3r	Medicinal products contained in the device	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3s	List of participating countries	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3t	Trial centres list	Yes, mandatory
3	Standard documentation to be submitted	Bulgaria	EU	3u	Declaration of possession of requirements for trial centres	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3v	Compliance to ISO 14155	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3w	MRI checklist	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3x	Ionising radiation information	N/A
3	Standard documentation to be submitted	Bulgaria	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
3	Patients' involvement	Bulgaria	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
3	Patients' involvement	Bulgaria	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
3	Patients' involvement	Bulgaria	EU	4b	Timing of patients’ involvement	N/A
3	HTA involvement	Bulgaria	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
3	HTA involvement	Bulgaria	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
3	HTA involvement	Bulgaria	EU	5b	Timing of HTA bodies’ involvement	N/A
3	Expert involvement	Bulgaria	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
3	Expert involvement	Bulgaria	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
3	Expert involvement	Bulgaria	EU	6b	Timing of expert panels’ involvement	N/A
3	Reimbursement	Bulgaria	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
3	Reimbursement	Bulgaria	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
4	General	Croatia	EU	1	Link to the website of the procedure	https://www.halmed.hr/en/O-HALMED-u/Sredisnje-eticko-povjerenstvo-SEP/Obrasci-za-davanje-misljenja-SEP-a/
4	Fee	Croatia	EU	2	Fee (€)	1. Mono-national trial - Part I 1991, II: 1062, I+II 3053 2. Multinational trial - RMS - Part I: 5309, II 1062, I+II 6371 3. Multinational trial - MSC - Part I: 1327, II: 1062, I+II 2389 4. Additional MSC application - I+II 2655 5. Non-commercial clinical trials Free of charge
4	Standard documentation to be submitted	Croatia	EU	3a	Cover letter	N/A
4	Standard documentation to be submitted	Croatia	EU	3b	Authorisation/application form	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3c	Investigator's Brochure	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3e	Copy of the opinion of the ethics committee	N/A
4	Standard documentation to be submitted	Croatia	EU	3f	Case Report Form (CRF)	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3h	Proof of insurance cover	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
4	Standard documentation to be submitted	Croatia	EU	3j	Proof of payment of the fee	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3k	Opinion of experts’ panels	N/A
4	Standard documentation to be submitted	Croatia	EU	3l	CE certificates of Notified Bodies	N/A
4	Standard documentation to be submitted	Croatia	EU	3m	Decisions of other Competent Authorities concerned	N/A
4	Standard documentation to be submitted	Croatia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
4	Standard documentation to be submitted	Croatia	EU	3o	Recruitment procedures and advertising materials	N/A
4	Standard documentation to be submitted	Croatia	EU	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3q	General Device Information	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3r	Medicinal products contained in the device	N/A
4	Standard documentation to be submitted	Croatia	EU	3s	List of participating countries	N/A
4	Standard documentation to be submitted	Croatia	EU	3t	Trial centres list	Yes, mandatory
4	Standard documentation to be submitted	Croatia	EU	3u	Declaration of possession of requirements for trial centres	N/A
4	Standard documentation to be submitted	Croatia	EU	3v	Compliance to ISO 14155	N/A
4	Standard documentation to be submitted	Croatia	EU	3w	MRI checklist	N/A
4	Standard documentation to be submitted	Croatia	EU	3x	Ionising radiation information	N/A
4	Standard documentation to be submitted	Croatia	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
4	Patients' involvement	Croatia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
4	Patients' involvement	Croatia	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
4	Patients' involvement	Croatia	EU	4b	Timing of patients’ involvement	N/A
4	HTA involvement	Croatia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
4	HTA involvement	Croatia	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
4	HTA involvement	Croatia	EU	5b	Timing of HTA bodies’ involvement	N/A
4	Expert involvement	Croatia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
4	Expert involvement	Croatia	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
4	Expert involvement	Croatia	EU	6b	Timing of expert panels’ involvement	N/A
4	Reimbursement	Croatia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
4	Reimbursement	Croatia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
5	General	Cyprus	EU	1	Link to the website of the procedure	https://www.moh.gov.cy/moh/mphs/mphs.nsf/page23_en/page23_en?OpenDocument
5	Fee	Cyprus	EU	2	Fee (€)	N/A
5	Standard documentation to be submitted	Cyprus	EU	3a	Cover letter	N/A
5	Standard documentation to be submitted	Cyprus	EU	3b	Authorisation/application form	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3c	Investigator's Brochure	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3f	Case Report Form (CRF)	N/A
5	Standard documentation to be submitted	Cyprus	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3h	Proof of insurance cover	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
5	Standard documentation to be submitted	Cyprus	EU	3j	Proof of payment of the fee	N/A
5	Standard documentation to be submitted	Cyprus	EU	3k	Opinion of experts’ panels	N/A
5	Standard documentation to be submitted	Cyprus	EU	3l	CE certificates of Notified Bodies	N/A
5	Standard documentation to be submitted	Cyprus	EU	3m	Decisions of other Competent Authorities concerned	N/A
5	Standard documentation to be submitted	Cyprus	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
5	Standard documentation to be submitted	Cyprus	EU	3o	Recruitment procedures and advertising materials	N/A
5	Standard documentation to be submitted	Cyprus	EU	3p	Opinion of other Ethics Committees concerned	N/A
5	Standard documentation to be submitted	Cyprus	EU	3q	General Device Information	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3r	Medicinal products contained in the device	N/A
5	Standard documentation to be submitted	Cyprus	EU	3s	List of participating countries	N/A
5	Standard documentation to be submitted	Cyprus	EU	3t	Trial centres list	Yes, mandatory
5	Standard documentation to be submitted	Cyprus	EU	3u	Declaration of possession of requirements for trial centres	N/A
5	Standard documentation to be submitted	Cyprus	EU	3v	Compliance to ISO 14155	N/A
5	Standard documentation to be submitted	Cyprus	EU	3w	MRI checklist	N/A
5	Standard documentation to be submitted	Cyprus	EU	3x	Ionising radiation information	N/A
5	Standard documentation to be submitted	Cyprus	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
5	Patients' involvement	Cyprus	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
5	Patients' involvement	Cyprus	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
5	Patients' involvement	Cyprus	EU	4b	Timing of patients’ involvement	N/A
5	HTA involvement	Cyprus	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
5	HTA involvement	Cyprus	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
5	HTA involvement	Cyprus	EU	5b	Timing of HTA bodies’ involvement	N/A
5	Expert involvement	Cyprus	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
5	Expert involvement	Cyprus	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
5	Expert involvement	Cyprus	EU	6b	Timing of expert panels’ involvement	N/A
5	Reimbursement	Cyprus	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
5	Reimbursement	Cyprus	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
6	General	Czechia	EU	1	Link to the website of the procedure	https://www.sukl.eu/medical-devices/podani-zadosti-o-povoleni-provedeni-klinicke-zkousky
6	Fee	Czechia	EU	2	Fee (€)	No fee
6	Standard documentation to be submitted	Czechia	EU	3a	Cover letter	N/A
6	Standard documentation to be submitted	Czechia	EU	3b	Authorisation/application form	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3c	Investigator's Brochure	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3f	Case Report Form (CRF)	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3h	Proof of insurance cover	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3j	Proof of payment of the fee	N/A
6	Standard documentation to be submitted	Czechia	EU	3k	Opinion of experts’ panels	N/A
6	Standard documentation to be submitted	Czechia	EU	3l	CE certificates of Notified Bodies	N/A
6	Standard documentation to be submitted	Czechia	EU	3m	Decisions of other Competent Authorities concerned	N/A
6	Standard documentation to be submitted	Czechia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
6	Standard documentation to be submitted	Czechia	EU	3o	Recruitment procedures and advertising materials	N/A
6	Standard documentation to be submitted	Czechia	EU	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3q	General Device Information	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3r	Medicinal products contained in the device	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3s	List of participating countries	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3t	Trial centres list	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3u	Declaration of possession of requirements for trial centres	N/A
6	Standard documentation to be submitted	Czechia	EU	3v	Compliance to ISO 14155	Yes, optional
6	Standard documentation to be submitted	Czechia	EU	3w	MRI checklist	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3x	Ionising radiation information	Yes, mandatory
6	Standard documentation to be submitted	Czechia	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
6	Patients' involvement	Czechia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
6	Patients' involvement	Czechia	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
6	Patients' involvement	Czechia	EU	4b	Timing of patients’ involvement	N/A
6	HTA involvement	Czechia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
6	HTA involvement	Czechia	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
6	HTA involvement	Czechia	EU	5b	Timing of HTA bodies’ involvement	N/A
6	Expert involvement	Czechia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
6	Expert involvement	Czechia	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
6	Expert involvement	Czechia	EU	6b	Timing of expert panels’ involvement	N/A
6	Reimbursement	Czechia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
6	Reimbursement	Czechia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
7	General	Denmark	EU	1	Link to the website of the procedure	https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
7	Fee	Denmark	EU	2	Fee (€)	I/IIa/IIb 936 IIb invasive/III 1258
7	Standard documentation to be submitted	Denmark	EU	3a	Cover letter	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3b	Authorisation/application form	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3c	Investigator's Brochure	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3f	Case Report Form (CRF)	N/A
7	Standard documentation to be submitted	Denmark	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3h	Proof of insurance cover	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3j	Proof of payment of the fee	N/A
7	Standard documentation to be submitted	Denmark	EU	3k	Opinion of experts’ panels	N/A
7	Standard documentation to be submitted	Denmark	EU	3l	CE certificates of Notified Bodies	N/A
7	Standard documentation to be submitted	Denmark	EU	3m	Decisions of other Competent Authorities concerned	N/A
7	Standard documentation to be submitted	Denmark	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
7	Standard documentation to be submitted	Denmark	EU	3o	Recruitment procedures and advertising materials	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3p	Opinion of other Ethics Committees concerned	N/A
7	Standard documentation to be submitted	Denmark	EU	3q	General Device Information	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3r	Medicinal products contained in the device	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3s	List of participating countries	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3t	Trial centres list	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3u	Declaration of possession of requirements for trial centres	N/A
7	Standard documentation to be submitted	Denmark	EU	3v	Compliance to ISO 14155	Yes, mandatory
7	Standard documentation to be submitted	Denmark	EU	3w	MRI checklist	N/A
7	Standard documentation to be submitted	Denmark	EU	3x	Ionising radiation information	N/A
7	Standard documentation to be submitted	Denmark	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
7	Patients' involvement	Denmark	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
7	Patients' involvement	Denmark	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
7	Patients' involvement	Denmark	EU	4b	Timing of patients’ involvement	N/A
7	HTA involvement	Denmark	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
7	HTA involvement	Denmark	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
7	HTA involvement	Denmark	EU	5b	Timing of HTA bodies’ involvement	N/A
7	Expert involvement	Denmark	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
7	Expert involvement	Denmark	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
7	Expert involvement	Denmark	EU	6b	Timing of expert panels’ involvement	N/A
7	Reimbursement	Denmark	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
7	Reimbursement	Denmark	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
8	General	Estonia	EU	1	Link to the website of the procedure	N/A
8	Fee	Estonia	EU	2	Fee (€)	210 state fee + 405 or 1457 (Health Board fee depending on the type of study requested)
8	Standard documentation to be submitted	Estonia	EU	3a	Cover letter	Yes, optional
8	Standard documentation to be submitted	Estonia	EU	3b	Authorisation/application form	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3c	Investigator's Brochure	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3f	Case Report Form (CRF)	No
8	Standard documentation to be submitted	Estonia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3h	Proof of insurance cover	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3j	Proof of payment of the fee	No
8	Standard documentation to be submitted	Estonia	EU	3k	Opinion of experts’ panels	No
8	Standard documentation to be submitted	Estonia	EU	3l	CE certificates of Notified Bodies	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3m	Decisions of other Competent Authorities concerned	No
8	Standard documentation to be submitted	Estonia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3o	Recruitment procedures and advertising materials	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3p	Opinion of other Ethics Committees concerned	Yes, optional
8	Standard documentation to be submitted	Estonia	EU	3q	General Device Information	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3r	Medicinal products contained in the device	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3s	List of participating countries	No
8	Standard documentation to be submitted	Estonia	EU	3t	Trial centres list	Yes, mandatory
8	Standard documentation to be submitted	Estonia	EU	3u	Declaration of possession of requirements for trial centres	No
8	Standard documentation to be submitted	Estonia	EU	3v	Compliance to ISO 14155	No
8	Standard documentation to be submitted	Estonia	EU	3w	MRI checklist	No
8	Standard documentation to be submitted	Estonia	EU	3x	Ionising radiation information	No
8	Standard documentation to be submitted	Estonia	EU	3y	Serious Adverse Event (SAE) Report Form	No
8	Patients' involvement	Estonia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
8	Patients' involvement	Estonia	EU	4a	Brief description of the type and extent of patients’ involvement	No
8	Patients' involvement	Estonia	EU	4b	Timing of patients’ involvement	No
8	HTA involvement	Estonia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
8	HTA involvement	Estonia	EU	5a	Brief description of the type and extent of HTA bodies involvement	No
8	HTA involvement	Estonia	EU	5b	Timing of HTA bodies’ involvement	No
8	Expert involvement	Estonia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
8	Expert involvement	Estonia	EU	6a	Brief description of the type and extent of expert panels’ involvement	No
8	Expert involvement	Estonia	EU	6b	Timing of expert panels’ involvement	No
8	Reimbursement	Estonia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
8	Reimbursement	Estonia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
9	General	Finland	EU	1	Link to the website of the procedure	https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
9	Fee	Finland	EU	2	Fee (€)	I 770 IIa to III 1930
9	Standard documentation to be submitted	Finland	EU	3a	Cover letter	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3b	Authorisation/application form	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3c	Investigator's Brochure	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3f	Case Report Form (CRF)	N/A
9	Standard documentation to be submitted	Finland	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3h	Proof of insurance cover	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3j	Proof of payment of the fee	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3k	Opinion of experts’ panels	Yes, optional
9	Standard documentation to be submitted	Finland	EU	3l	CE certificates of Notified Bodies	Yes, optional
9	Standard documentation to be submitted	Finland	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
9	Standard documentation to be submitted	Finland	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
9	Standard documentation to be submitted	Finland	EU	3o	Recruitment procedures and advertising materials	Yes, optional
9	Standard documentation to be submitted	Finland	EU	3p	Opinion of other Ethics Committees concerned	N/A
9	Standard documentation to be submitted	Finland	EU	3q	General Device Information	N/A
9	Standard documentation to be submitted	Finland	EU	3r	Medicinal products contained in the device	N/A
9	Standard documentation to be submitted	Finland	EU	3s	List of participating countries	N/A
9	Standard documentation to be submitted	Finland	EU	3t	Trial centres list	Yes, mandatory
9	Standard documentation to be submitted	Finland	EU	3u	Declaration of possession of requirements for trial centres	N/A
9	Standard documentation to be submitted	Finland	EU	3v	Compliance to ISO 14155	N/A
9	Standard documentation to be submitted	Finland	EU	3w	MRI checklist	N/A
9	Standard documentation to be submitted	Finland	EU	3x	Ionising radiation information	N/A
9	Standard documentation to be submitted	Finland	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
9	Patients' involvement	Finland	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
9	Patients' involvement	Finland	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
9	Patients' involvement	Finland	EU	4b	Timing of patients’ involvement	N/A
9	HTA involvement	Finland	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
9	HTA involvement	Finland	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
9	HTA involvement	Finland	EU	5b	Timing of HTA bodies’ involvement	N/A
9	Expert involvement	Finland	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
9	Expert involvement	Finland	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
9	Expert involvement	Finland	EU	6b	Timing of expert panels’ involvement	N/A
9	Reimbursement	Finland	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
9	Reimbursement	Finland	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
10	General	France	EU	1	Link to the website of the procedure	Dispositifs médicaux - Demander une autorisation pour une inves - ANSM (sante.fr)
10	Fee	France	EU	2	Fee (€)	N/A
10	Standard documentation to be submitted	France	EU	3a	Cover letter	N/A
10	Standard documentation to be submitted	France	EU	3b	Authorisation/application form	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3c	Investigator's Brochure	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3e	Copy of the opinion of the ethics committee	Yes, optional
10	Standard documentation to be submitted	France	EU	3f	Case Report Form (CRF)	N/A
10	Standard documentation to be submitted	France	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3h	Proof of insurance cover	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3j	Proof of payment of the fee	N/A
10	Standard documentation to be submitted	France	EU	3k	Opinion of experts’ panels	Yes, optional
10	Standard documentation to be submitted	France	EU	3l	CE certificates of Notified Bodies	No
10	Standard documentation to be submitted	France	EU	3m	Decisions of other Competent Authorities concerned	N/A
10	Standard documentation to be submitted	France	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3o	Recruitment procedures and advertising materials	N/A
10	Standard documentation to be submitted	France	EU	3p	Opinion of other Ethics Committees concerned	N/A
10	Standard documentation to be submitted	France	EU	3q	General Device Information	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3r	Medicinal products contained in the device	Yes, mandatory
10	Standard documentation to be submitted	France	EU	3s	List of participating countries	N/A
10	Standard documentation to be submitted	France	EU	3t	Trial centres list	N/A
10	Standard documentation to be submitted	France	EU	3u	Declaration of possession of requirements for trial centres	N/A
10	Standard documentation to be submitted	France	EU	3v	Compliance to ISO 14155	N/A
10	Standard documentation to be submitted	France	EU	3w	MRI checklist	N/A
10	Standard documentation to be submitted	France	EU	3x	Ionising radiation information	Yes, optional
10	Standard documentation to be submitted	France	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
10	Patients' involvement	France	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
10	Patients' involvement	France	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
10	Patients' involvement	France	EU	4b	Timing of patients’ involvement	N/A
10	HTA involvement	France	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
10	HTA involvement	France	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
10	HTA involvement	France	EU	5b	Timing of HTA bodies’ involvement	N/A
10	Expert involvement	France	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
10	Expert involvement	France	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
10	Expert involvement	France	EU	6b	Timing of expert panels’ involvement	N/A
10	Reimbursement	France	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
10	Reimbursement	France	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
11	General	Germany	EU	1	Link to the website of the procedure	https://www.bfarm.de/EN/Medical-devices/Tasks/Clinical-investigations-and-performance-studies/Clinical-investigations/Request-for-authorisation-kp/_node.html
11	Fee	Germany	EU	2	Fee (€)	The final fee is not determined until the end of a procedure.
11	Standard documentation to be submitted	Germany	EU	3a	Cover letter	No
11	Standard documentation to be submitted	Germany	EU	3b	Authorisation/application form	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3c	Investigator's Brochure	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3f	Case Report Form (CRF)	N/A
11	Standard documentation to be submitted	Germany	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3h	Proof of insurance cover	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3j	Proof of payment of the fee	N/A
11	Standard documentation to be submitted	Germany	EU	3k	Opinion of experts’ panels	N/A
11	Standard documentation to be submitted	Germany	EU	3l	CE certificates of Notified Bodies	N/A
11	Standard documentation to be submitted	Germany	EU	3m	Decisions of other Competent Authorities concerned	N/A
11	Standard documentation to be submitted	Germany	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
11	Standard documentation to be submitted	Germany	EU	3o	Recruitment procedures and advertising materials	N/A
11	Standard documentation to be submitted	Germany	EU	3p	Opinion of other Ethics Committees concerned	N/A
11	Standard documentation to be submitted	Germany	EU	3q	General Device Information	N/A
11	Standard documentation to be submitted	Germany	EU	3r	Medicinal products contained in the device	N/A
11	Standard documentation to be submitted	Germany	EU	3s	List of participating countries	N/A
11	Standard documentation to be submitted	Germany	EU	3t	Trial centres list	N/A
11	Standard documentation to be submitted	Germany	EU	3u	Declaration of possession of requirements for trial centres	N/A
11	Standard documentation to be submitted	Germany	EU	3v	Compliance to ISO 14155	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3w	MRI checklist	No
11	Standard documentation to be submitted	Germany	EU	3x	Ionising radiation information	Yes, mandatory
11	Standard documentation to be submitted	Germany	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
11	Patients' involvement	Germany	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
11	Patients' involvement	Germany	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
11	Patients' involvement	Germany	EU	4b	Timing of patients’ involvement	N/A
11	HTA involvement	Germany	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
11	HTA involvement	Germany	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
11	HTA involvement	Germany	EU	5b	Timing of HTA bodies’ involvement	N/A
11	Expert involvement	Germany	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
11	Expert involvement	Germany	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
11	Expert involvement	Germany	EU	6b	Timing of expert panels’ involvement	N/A
11	Reimbursement	Germany	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
11	Reimbursement	Germany	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
12	General	Greece	EU	1	Link to the website of the procedure	https://www.eof.gr/web/guest/clinical-md
12	Fee	Greece	EU	2	Fee (€)	1000
12	Standard documentation to be submitted	Greece	EU	3a	Cover letter	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3b	Authorisation/application form	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3c	Investigator's Brochure	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3e	Copy of the opinion of the ethics committee	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3f	Case Report Form (CRF)	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3h	Proof of insurance cover	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3j	Proof of payment of the fee	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3k	Opinion of experts’ panels	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3l	CE certificates of Notified Bodies	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3o	Recruitment procedures and advertising materials	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3p	Opinion of other Ethics Committees concerned	Yes, optional
12	Standard documentation to be submitted	Greece	EU	3q	General Device Information	N/A
12	Standard documentation to be submitted	Greece	EU	3r	Medicinal products contained in the device	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3s	List of participating countries	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3t	Trial centres list	Yes, mandatory
12	Standard documentation to be submitted	Greece	EU	3u	Declaration of possession of requirements for trial centres	N/A
12	Standard documentation to be submitted	Greece	EU	3v	Compliance to ISO 14155	N/A
12	Standard documentation to be submitted	Greece	EU	3w	MRI checklist	N/A
12	Standard documentation to be submitted	Greece	EU	3x	Ionising radiation information	N/A
12	Standard documentation to be submitted	Greece	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
12	Patients' involvement	Greece	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
12	Patients' involvement	Greece	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
12	Patients' involvement	Greece	EU	4b	Timing of patients’ involvement	N/A
12	HTA involvement	Greece	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
12	HTA involvement	Greece	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
12	HTA involvement	Greece	EU	5b	Timing of HTA bodies’ involvement	N/A
12	Expert involvement	Greece	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
12	Expert involvement	Greece	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
12	Expert involvement	Greece	EU	6b	Timing of expert panels’ involvement	N/A
12	Reimbursement	Greece	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
12	Reimbursement	Greece	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
13	General	Hungary	EU	1	Link to the website of the procedure	https://ogyei.gov.hu/klinikai_vizsgalatok_orvostechnika
13	Fee	Hungary	EU	2	Fee (€)	Non-radioactive 468 Radioactive 764
13	Standard documentation to be submitted	Hungary	EU	3a	Cover letter	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3b	Authorisation/application form	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3c	Investigator's Brochure	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3f	Case Report Form (CRF)	N/A
13	Standard documentation to be submitted	Hungary	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3h	Proof of insurance cover	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3j	Proof of payment of the fee	Yes, optional
13	Standard documentation to be submitted	Hungary	EU	3k	Opinion of experts’ panels	Yes, optional
13	Standard documentation to be submitted	Hungary	EU	3l	CE certificates of Notified Bodies	Yes, optional
13	Standard documentation to be submitted	Hungary	EU	3m	Decisions of other Competent Authorities concerned	N/A
13	Standard documentation to be submitted	Hungary	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
13	Standard documentation to be submitted	Hungary	EU	3o	Recruitment procedures and advertising materials	Yes, optional
13	Standard documentation to be submitted	Hungary	EU	3p	Opinion of other Ethics Committees concerned	N/A
13	Standard documentation to be submitted	Hungary	EU	3q	General Device Information	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3r	Medicinal products contained in the device	N/A
13	Standard documentation to be submitted	Hungary	EU	3s	List of participating countries	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3t	Trial centres list	N/A
13	Standard documentation to be submitted	Hungary	EU	3u	Declaration of possession of requirements for trial centres	N/A
13	Standard documentation to be submitted	Hungary	EU	3v	Compliance to ISO 14155	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3w	MRI checklist	N/A
13	Standard documentation to be submitted	Hungary	EU	3x	Ionising radiation information	Yes, mandatory
13	Standard documentation to be submitted	Hungary	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
13	Patients' involvement	Hungary	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
13	Patients' involvement	Hungary	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
13	Patients' involvement	Hungary	EU	4b	Timing of patients’ involvement	N/A
13	HTA involvement	Hungary	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
13	HTA involvement	Hungary	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
13	HTA involvement	Hungary	EU	5b	Timing of HTA bodies’ involvement	N/A
13	Expert involvement	Hungary	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
13	Expert involvement	Hungary	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
13	Expert involvement	Hungary	EU	6b	Timing of expert panels’ involvement	N/A
13	Reimbursement	Hungary	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
13	Reimbursement	Hungary	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
14	General	Ireland	EU	1	Link to the website of the procedure	https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0095-guide-to-clinical-investigations-carried-out-in-ireland-v7.pdf?sfvrsn=34
14	Fee	Ireland	EU	2	Fee (€)	I/IIa 1930 IIb/III 4365 Resubmission of a clinical investigation/performance study/accademic sponsor 520
14	Standard documentation to be submitted	Ireland	EU	3a	Cover letter	N/A
14	Standard documentation to be submitted	Ireland	EU	3b	Authorisation/application form	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3c	Investigator's Brochure	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3e	Copy of the opinion of the ethics committee	Yes, optional
14	Standard documentation to be submitted	Ireland	EU	3f	Case Report Form (CRF)	N/A
14	Standard documentation to be submitted	Ireland	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3h	Proof of insurance cover	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3j	Proof of payment of the fee	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3k	Opinion of experts’ panels	N/A
14	Standard documentation to be submitted	Ireland	EU	3l	CE certificates of Notified Bodies	N/A
14	Standard documentation to be submitted	Ireland	EU	3m	Decisions of other Competent Authorities concerned	N/A
14	Standard documentation to be submitted	Ireland	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
14	Standard documentation to be submitted	Ireland	EU	3o	Recruitment procedures and advertising materials	N/A
14	Standard documentation to be submitted	Ireland	EU	3p	Opinion of other Ethics Committees concerned	N/A
14	Standard documentation to be submitted	Ireland	EU	3q	General Device Information	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3r	Medicinal products contained in the device	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3s	List of participating countries	Yes, mandatory
14	Standard documentation to be submitted	Ireland	EU	3t	Trial centres list	N/A
14	Standard documentation to be submitted	Ireland	EU	3u	Declaration of possession of requirements for trial centres	N/A
14	Standard documentation to be submitted	Ireland	EU	3v	Compliance to ISO 14155	N/A
14	Standard documentation to be submitted	Ireland	EU	3w	MRI checklist	N/A
14	Standard documentation to be submitted	Ireland	EU	3x	Ionising radiation information	N/A
14	Standard documentation to be submitted	Ireland	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
14	Patients' involvement	Ireland	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
14	Patients' involvement	Ireland	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
14	Patients' involvement	Ireland	EU	4b	Timing of patients’ involvement	N/A
14	HTA involvement	Ireland	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
14	HTA involvement	Ireland	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
14	HTA involvement	Ireland	EU	5b	Timing of HTA bodies’ involvement	N/A
14	Expert involvement	Ireland	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
14	Expert involvement	Ireland	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
14	Expert involvement	Ireland	EU	6b	Timing of expert panels’ involvement	N/A
14	Reimbursement	Ireland	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
14	Reimbursement	Ireland	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
15	General	Italy	EU	1	Link to the website of the procedure	https://www.salute.gov.it/portale/moduliServizi/dettaglioSchedaModuliServizi.jsp?lingua=italiano&menu=ufficio&label=servizionline&ufficio=&idMat=DM&idAmb=SC&idSrv=PRE2&flag=P&parolaUfficio=&gruppoUfficio=ALL&gruppoUfficioDir=DGDMF-UFFXIV
15	Fee	Italy	EU	2	Fee (€)	3398
15	Standard documentation to be submitted	Italy	EU	3a	Cover letter	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3b	Authorisation/application form	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3c	Investigator's Brochure	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3f	Case Report Form (CRF)	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3h	Proof of insurance cover	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3j	Proof of payment of the fee	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3k	Opinion of experts’ panels	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3l	CE certificates of Notified Bodies	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3o	Recruitment procedures and advertising materials	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3p	Opinion of other Ethics Committees concerned	Yes, optional
15	Standard documentation to be submitted	Italy	EU	3q	General Device Information	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3r	Medicinal products contained in the device	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3s	List of participating countries	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3t	Trial centres list	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
15	Standard documentation to be submitted	Italy	EU	3v	Compliance to ISO 14155	N/A
15	Standard documentation to be submitted	Italy	EU	3w	MRI checklist	N/A
15	Standard documentation to be submitted	Italy	EU	3x	Ionising radiation information	N/A
15	Standard documentation to be submitted	Italy	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
15	Patients' involvement	Italy	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
15	Patients' involvement	Italy	EU	4a	Brief description of the type and extent of patients’ involvement	No
15	Patients' involvement	Italy	EU	4b	Timing of patients’ involvement	No
15	HTA involvement	Italy	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
15	HTA involvement	Italy	EU	5a	Brief description of the type and extent of HTA bodies involvement	No
15	HTA involvement	Italy	EU	5b	Timing of HTA bodies’ involvement	No
15	Expert involvement	Italy	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
15	Expert involvement	Italy	EU	6a	Brief description of the type and extent of expert panels’ involvement	No
15	Expert involvement	Italy	EU	6b	Timing of expert panels’ involvement	No
15	Reimbursement	Italy	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
15	Reimbursement	Italy	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
16	General	Latvia	EU	1	Link to the website of the procedure	N/A
16	Fee	Latvia	EU	2	Fee (€)	Initial application 1500 Substantial modification CI 900
16	Standard documentation to be submitted	Latvia	EU	3a	Cover letter	Yes, optional
16	Standard documentation to be submitted	Latvia	EU	3b	Authorisation/application form	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3c	Investigator's Brochure	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3f	Case Report Form (CRF)	No
16	Standard documentation to be submitted	Latvia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3h	Proof of insurance cover	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3j	Proof of payment of the fee	No
16	Standard documentation to be submitted	Latvia	EU	3k	Opinion of experts’ panels	Yes, optional
16	Standard documentation to be submitted	Latvia	EU	3l	CE certificates of Notified Bodies	N/A
16	Standard documentation to be submitted	Latvia	EU	3m	Decisions of other Competent Authorities concerned	N/A
16	Standard documentation to be submitted	Latvia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
16	Standard documentation to be submitted	Latvia	EU	3o	Recruitment procedures and advertising materials	N/A
16	Standard documentation to be submitted	Latvia	EU	3p	Opinion of other Ethics Committees concerned	N/A
16	Standard documentation to be submitted	Latvia	EU	3q	General Device Information	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3r	Medicinal products contained in the device	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3s	List of participating countries	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3t	Trial centres list	Yes, mandatory
16	Standard documentation to be submitted	Latvia	EU	3u	Declaration of possession of requirements for trial centres	N/A
16	Standard documentation to be submitted	Latvia	EU	3v	Compliance to ISO 14155	N/A
16	Standard documentation to be submitted	Latvia	EU	3w	MRI checklist	N/A
16	Standard documentation to be submitted	Latvia	EU	3x	Ionising radiation information	Yes, optional
16	Standard documentation to be submitted	Latvia	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
16	Patients' involvement	Latvia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
16	Patients' involvement	Latvia	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
16	Patients' involvement	Latvia	EU	4b	Timing of patients’ involvement	N/A
16	HTA involvement	Latvia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
16	HTA involvement	Latvia	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
16	HTA involvement	Latvia	EU	5b	Timing of HTA bodies’ involvement	N/A
16	Expert involvement	Latvia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
16	Expert involvement	Latvia	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
16	Expert involvement	Latvia	EU	6b	Timing of expert panels’ involvement	N/A
16	Reimbursement	Latvia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
16	Reimbursement	Latvia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
17	General	Lithuania	EU	1	Link to the website of the procedure	https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/6abb8a40302911eb8c97e01ffe050e1c/asr
17	Fee	Lithuania	EU	2	Fee (€)	1407
17	Standard documentation to be submitted	Lithuania	EU	3a	Cover letter	N/A
17	Standard documentation to be submitted	Lithuania	EU	3b	Authorisation/application form	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3c	Investigator's Brochure	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3f	Case Report Form (CRF)	N/A
17	Standard documentation to be submitted	Lithuania	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3h	Proof of insurance cover	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3j	Proof of payment of the fee	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3k	Opinion of experts’ panels	N/A
17	Standard documentation to be submitted	Lithuania	EU	3l	CE certificates of Notified Bodies	N/A
17	Standard documentation to be submitted	Lithuania	EU	3m	Decisions of other Competent Authorities concerned	N/A
17	Standard documentation to be submitted	Lithuania	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
17	Standard documentation to be submitted	Lithuania	EU	3o	Recruitment procedures and advertising materials	N/A
17	Standard documentation to be submitted	Lithuania	EU	3p	Opinion of other Ethics Committees concerned	N/A
17	Standard documentation to be submitted	Lithuania	EU	3q	General Device Information	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3r	Medicinal products contained in the device	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3s	List of participating countries	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3t	Trial centres list	Yes, mandatory
17	Standard documentation to be submitted	Lithuania	EU	3u	Declaration of possession of requirements for trial centres	N/A
17	Standard documentation to be submitted	Lithuania	EU	3v	Compliance to ISO 14155	N/A
17	Standard documentation to be submitted	Lithuania	EU	3w	MRI checklist	N/A
17	Standard documentation to be submitted	Lithuania	EU	3x	Ionising radiation information	Yes, optional
17	Standard documentation to be submitted	Lithuania	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
17	Patients' involvement	Lithuania	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
17	Patients' involvement	Lithuania	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
17	Patients' involvement	Lithuania	EU	4b	Timing of patients’ involvement	N/A
17	HTA involvement	Lithuania	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
17	HTA involvement	Lithuania	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
17	HTA involvement	Lithuania	EU	5b	Timing of HTA bodies’ involvement	N/A
17	Expert involvement	Lithuania	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
17	Expert involvement	Lithuania	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
17	Expert involvement	Lithuania	EU	6b	Timing of expert panels’ involvement	N/A
17	Reimbursement	Lithuania	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
17	Reimbursement	Lithuania	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
18	General	Luxembourg	EU	1	Link to the website of the procedure	https://sante.public.lu/fr/espace-professionnel/domaines/recherche-biomedicale/investigation-clinique-dispositifs-medicaux.html
18	Fee	Luxembourg	EU	2	Fee (€)	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3a	Cover letter	No
18	Standard documentation to be submitted	Luxembourg	EU	3b	Authorisation/application form	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3c	Investigator's Brochure	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3e	Copy of the opinion of the ethics committee	No
18	Standard documentation to be submitted	Luxembourg	EU	3f	Case Report Form (CRF)	No
18	Standard documentation to be submitted	Luxembourg	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3h	Proof of insurance cover	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3j	Proof of payment of the fee	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3k	Opinion of experts’ panels	Yes, optional
18	Standard documentation to be submitted	Luxembourg	EU	3l	CE certificates of Notified Bodies	Yes, optional
18	Standard documentation to be submitted	Luxembourg	EU	3m	Decisions of other Competent Authorities concerned	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3n	Post Market Clinical Follow-up (PMCF) plan	No
18	Standard documentation to be submitted	Luxembourg	EU	3o	Recruitment procedures and advertising materials	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3p	Opinion of other Ethics Committees concerned	No
18	Standard documentation to be submitted	Luxembourg	EU	3q	General Device Information	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3r	Medicinal products contained in the device	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3s	List of participating countries	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3t	Trial centres list	Yes, mandatory
18	Standard documentation to be submitted	Luxembourg	EU	3u	Declaration of possession of requirements for trial centres	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3v	Compliance to ISO 14155	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3w	MRI checklist	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3x	Ionising radiation information	N/A
18	Standard documentation to be submitted	Luxembourg	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
18	Patients' involvement	Luxembourg	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
18	Patients' involvement	Luxembourg	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
18	Patients' involvement	Luxembourg	EU	4b	Timing of patients’ involvement	N/A
18	HTA involvement	Luxembourg	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
18	HTA involvement	Luxembourg	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
18	HTA involvement	Luxembourg	EU	5b	Timing of HTA bodies’ involvement	N/A
18	Expert involvement	Luxembourg	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
18	Expert involvement	Luxembourg	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
18	Expert involvement	Luxembourg	EU	6b	Timing of expert panels’ involvement	N/A
18	Reimbursement	Luxembourg	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
18	Reimbursement	Luxembourg	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
19	General	Malta	EU	1	Link to the website of the procedure	Medicines Authority (gov.mt)
19	Fee	Malta	EU	2	Fee (€)	5000
19	Standard documentation to be submitted	Malta	EU	3a	Cover letter	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3b	Authorisation/application form	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3c	Investigator's Brochure	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3f	Case Report Form (CRF)	N/A
19	Standard documentation to be submitted	Malta	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3h	Proof of insurance cover	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3j	Proof of payment of the fee	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3k	Opinion of experts’ panels	Yes, optional
19	Standard documentation to be submitted	Malta	EU	3l	CE certificates of Notified Bodies	Yes, optional
19	Standard documentation to be submitted	Malta	EU	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
19	Standard documentation to be submitted	Malta	EU	3o	Recruitment procedures and advertising materials	Yes, optional
19	Standard documentation to be submitted	Malta	EU	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3q	General Device Information	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3r	Medicinal products contained in the device	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3s	List of participating countries	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3t	Trial centres list	Yes, mandatory
19	Standard documentation to be submitted	Malta	EU	3u	Declaration of possession of requirements for trial centres	N/A
19	Standard documentation to be submitted	Malta	EU	3v	Compliance to ISO 14155	N/A
19	Standard documentation to be submitted	Malta	EU	3w	MRI checklist	N/A
19	Standard documentation to be submitted	Malta	EU	3x	Ionising radiation information	N/A
19	Standard documentation to be submitted	Malta	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
19	Patients' involvement	Malta	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
19	Patients' involvement	Malta	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
19	Patients' involvement	Malta	EU	4b	Timing of patients’ involvement	N/A
19	HTA involvement	Malta	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
19	HTA involvement	Malta	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
19	HTA involvement	Malta	EU	5b	Timing of HTA bodies’ involvement	N/A
19	Expert involvement	Malta	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
19	Expert involvement	Malta	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
19	Expert involvement	Malta	EU	6b	Timing of expert panels’ involvement	N/A
19	Reimbursement	Malta	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
19	Reimbursement	Malta	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
20	General	Netherlands	EU	1	Link to the website of the procedure	https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices/primary-submission-investigations-with-medical-devices
20	Fee	Netherlands	EU	2	Fee (€)	Initial application 7320 Device modification 2440
20	Standard documentation to be submitted	Netherlands	EU	3a	Cover letter	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3b	Authorisation/application form	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3c	Investigator's Brochure	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3e	Copy of the opinion of the ethics committee	N/A
20	Standard documentation to be submitted	Netherlands	EU	3f	Case Report Form (CRF)	N/A
20	Standard documentation to be submitted	Netherlands	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3h	Proof of insurance cover	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3j	Proof of payment of the fee	N/A
20	Standard documentation to be submitted	Netherlands	EU	3k	Opinion of experts’ panels	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3l	CE certificates of Notified Bodies	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3o	Recruitment procedures and advertising materials	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3p	Opinion of other Ethics Committees concerned	N/A
20	Standard documentation to be submitted	Netherlands	EU	3q	General Device Information	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3r	Medicinal products contained in the device	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3s	List of participating countries	N/A
20	Standard documentation to be submitted	Netherlands	EU	3t	Trial centres list	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
20	Standard documentation to be submitted	Netherlands	EU	3v	Compliance to ISO 14155	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3w	MRI checklist	N/A
20	Standard documentation to be submitted	Netherlands	EU	3x	Ionising radiation information	Yes, optional
20	Standard documentation to be submitted	Netherlands	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
20	Patients' involvement	Netherlands	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
20	Patients' involvement	Netherlands	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
20	Patients' involvement	Netherlands	EU	4b	Timing of patients’ involvement	N/A
20	HTA involvement	Netherlands	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
20	HTA involvement	Netherlands	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
20	HTA involvement	Netherlands	EU	5b	Timing of HTA bodies’ involvement	N/A
20	Expert involvement	Netherlands	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
20	Expert involvement	Netherlands	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
20	Expert involvement	Netherlands	EU	6b	Timing of expert panels’ involvement	N/A
20	Reimbursement	Netherlands	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
20	Reimbursement	Netherlands	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
21	General	Poland	EU	1	Link to the website of the procedure	N/A
21	Fee	Poland	EU	2	Fee (€)	Initial application 1404.78 Substantial amendments 475
21	Standard documentation to be submitted	Poland	EU	3a	Cover letter	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3b	Authorisation/application form	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3c	Investigator's Brochure	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3e	Copy of the opinion of the ethics committee	Yes
21	Standard documentation to be submitted	Poland	EU	3f	Case Report Form (CRF)	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3h	Proof of insurance cover	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes
21	Standard documentation to be submitted	Poland	EU	3j	Proof of payment of the fee	Yes
21	Standard documentation to be submitted	Poland	EU	3k	Opinion of experts’ panels	N/A
21	Standard documentation to be submitted	Poland	EU	3l	CE certificates of Notified Bodies	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
21	Standard documentation to be submitted	Poland	EU	3n	Post Market Clinical Follow-up (PMCF) plan	No
21	Standard documentation to be submitted	Poland	EU	3o	Recruitment procedures and advertising materials	Yes, optional
21	Standard documentation to be submitted	Poland	EU	3p	Opinion of other Ethics Committees concerned	No
21	Standard documentation to be submitted	Poland	EU	3q	General Device Information	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3r	Medicinal products contained in the device	If applicable
21	Standard documentation to be submitted	Poland	EU	3s	List of participating countries	Yes
21	Standard documentation to be submitted	Poland	EU	3t	Trial centres list	Yes, optional
21	Standard documentation to be submitted	Poland	EU	3u	Declaration of possession of requirements for trial centres	Yes, optional
21	Standard documentation to be submitted	Poland	EU	3v	Compliance to ISO 14155	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3w	MRI checklist	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3x	Ionising radiation information	Yes, mandatory
21	Standard documentation to be submitted	Poland	EU	3y	Serious Adverse Event (SAE) Report Form	No
21	Patients' involvement	Poland	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
21	Patients' involvement	Poland	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
21	Patients' involvement	Poland	EU	4b	Timing of patients’ involvement	N/A
21	HTA involvement	Poland	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
21	HTA involvement	Poland	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
21	HTA involvement	Poland	EU	5b	Timing of HTA bodies’ involvement	N/A
21	Expert involvement	Poland	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
21	Expert involvement	Poland	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
21	Expert involvement	Poland	EU	6b	Timing of expert panels’ involvement	N/A
21	Reimbursement	Poland	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
21	Reimbursement	Poland	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
22	General	Portugal	EU	1	Link to the website of the procedure	https://www.rnec.pt/ https://www.rnec.pt/como-submeter-um-pedido-de-realizacao-de-ic-dispositivos-em-portugal-
22	Fee	Portugal	EU	2	Fee (€)	1000
22	Standard documentation to be submitted	Portugal	EU	3a	Cover letter	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3b	Authorisation/application form	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3c	Investigator's Brochure	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3e	Copy of the opinion of the ethics committee	No
22	Standard documentation to be submitted	Portugal	EU	3f	Case Report Form (CRF)	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3h	Proof of insurance cover	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3j	Proof of payment of the fee	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3k	Opinion of experts’ panels	Yes, optional
22	Standard documentation to be submitted	Portugal	EU	3l	CE certificates of Notified Bodies	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3m	Decisions of other Competent Authorities concerned	Yes, optional
22	Standard documentation to be submitted	Portugal	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3o	Recruitment procedures and advertising materials	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3p	Opinion of other Ethics Committees concerned	N/A
22	Standard documentation to be submitted	Portugal	EU	3q	General Device Information	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3r	Medicinal products contained in the device	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3s	List of participating countries	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3t	Trial centres list	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3u	Declaration of possession of requirements for trial centres	No
22	Standard documentation to be submitted	Portugal	EU	3v	Compliance to ISO 14155	Yes, mandatory
22	Standard documentation to be submitted	Portugal	EU	3w	MRI checklist	N/A
22	Standard documentation to be submitted	Portugal	EU	3x	Ionising radiation information	N/A
22	Standard documentation to be submitted	Portugal	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
22	Patients' involvement	Portugal	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
22	Patients' involvement	Portugal	EU	4a	Brief description of the type and extent of patients’ involvement	No
22	Patients' involvement	Portugal	EU	4b	Timing of patients’ involvement	No
22	HTA involvement	Portugal	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
22	HTA involvement	Portugal	EU	5a	Brief description of the type and extent of HTA bodies involvement	No
22	HTA involvement	Portugal	EU	5b	Timing of HTA bodies’ involvement	No
22	Expert involvement	Portugal	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
22	Expert involvement	Portugal	EU	6a	Brief description of the type and extent of expert panels’ involvement	No
22	Expert involvement	Portugal	EU	6b	Timing of expert panels’ involvement	No
22	Reimbursement	Portugal	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
22	Reimbursement	Portugal	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
23	General	Romania	EU	1	Link to the website of the procedure	N/A
23	Fee	Romania	EU	2	Fee (€)	I/IIa 1754 IIa/IIb non-invasive 3606 IIb invasive/III 4090
23	Standard documentation to be submitted	Romania	EU	3a	Cover letter	N/A
23	Standard documentation to be submitted	Romania	EU	3b	Authorisation/application form	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3c	Investigator's Brochure	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3f	Case Report Form (CRF)	N/A
23	Standard documentation to be submitted	Romania	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3h	Proof of insurance cover	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
23	Standard documentation to be submitted	Romania	EU	3j	Proof of payment of the fee	N/A
23	Standard documentation to be submitted	Romania	EU	3k	Opinion of experts’ panels	N/A
23	Standard documentation to be submitted	Romania	EU	3l	CE certificates of Notified Bodies	N/A
23	Standard documentation to be submitted	Romania	EU	3m	Decisions of other Competent Authorities concerned	N/A
23	Standard documentation to be submitted	Romania	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
23	Standard documentation to be submitted	Romania	EU	3o	Recruitment procedures and advertising materials	N/A
23	Standard documentation to be submitted	Romania	EU	3p	Opinion of other Ethics Committees concerned	N/A
23	Standard documentation to be submitted	Romania	EU	3q	General Device Information	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3r	Medicinal products contained in the device	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3s	List of participating countries	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3t	Trial centres list	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3u	Declaration of possession of requirements for trial centres	N/A
23	Standard documentation to be submitted	Romania	EU	3v	Compliance to ISO 14155	Yes, mandatory
23	Standard documentation to be submitted	Romania	EU	3w	MRI checklist	N/A
23	Standard documentation to be submitted	Romania	EU	3x	Ionising radiation information	N/A
23	Standard documentation to be submitted	Romania	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
23	Patients' involvement	Romania	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
23	Patients' involvement	Romania	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
23	Patients' involvement	Romania	EU	4b	Timing of patients’ involvement	N/A
23	HTA involvement	Romania	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
23	HTA involvement	Romania	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
23	HTA involvement	Romania	EU	5b	Timing of HTA bodies’ involvement	N/A
23	Expert involvement	Romania	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
23	Expert involvement	Romania	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
23	Expert involvement	Romania	EU	6b	Timing of expert panels’ involvement	N/A
23	Reimbursement	Romania	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
23	Reimbursement	Romania	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
24	General	Slovakia	EU	1	Link to the website of the procedure	https://www.sukl.sk/sk/zdravotnicke-pomocky-informacie/informacie-tykajuce-sa-trhoveho-dohladu-vigilancie-a-klinickeho-skusania?page_id=5699
24	Fee	Slovakia	EU	2	Fee (€)	500
24	Standard documentation to be submitted	Slovakia	EU	3a	Cover letter	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3b	Authorisation/application form	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3c	Investigator's Brochure	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3e	Copy of the opinion of the ethics committee	Yes, optional
24	Standard documentation to be submitted	Slovakia	EU	3f	Case Report Form (CRF)	N/A
24	Standard documentation to be submitted	Slovakia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3h	Proof of insurance cover	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3j	Proof of payment of the fee	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3k	Opinion of experts’ panels	N/A
24	Standard documentation to be submitted	Slovakia	EU	3l	CE certificates of Notified Bodies	N/A
24	Standard documentation to be submitted	Slovakia	EU	3m	Decisions of other Competent Authorities concerned	N/A
24	Standard documentation to be submitted	Slovakia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
24	Standard documentation to be submitted	Slovakia	EU	3o	Recruitment procedures and advertising materials	N/A
24	Standard documentation to be submitted	Slovakia	EU	3p	Opinion of other Ethics Committees concerned	Yes, optional
24	Standard documentation to be submitted	Slovakia	EU	3q	General Device Information	N/A
24	Standard documentation to be submitted	Slovakia	EU	3r	Medicinal products contained in the device	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3s	List of participating countries	N/A
24	Standard documentation to be submitted	Slovakia	EU	3t	Trial centres list	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
24	Standard documentation to be submitted	Slovakia	EU	3v	Compliance to ISO 14155	N/A
24	Standard documentation to be submitted	Slovakia	EU	3w	MRI checklist	N/A
24	Standard documentation to be submitted	Slovakia	EU	3x	Ionising radiation information	N/A
24	Standard documentation to be submitted	Slovakia	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
24	Patients' involvement	Slovakia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
24	Patients' involvement	Slovakia	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
24	Patients' involvement	Slovakia	EU	4b	Timing of patients’ involvement	N/A
24	HTA involvement	Slovakia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
24	HTA involvement	Slovakia	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
24	HTA involvement	Slovakia	EU	5b	Timing of HTA bodies’ involvement	N/A
24	Expert involvement	Slovakia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
24	Expert involvement	Slovakia	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
24	Expert involvement	Slovakia	EU	6b	Timing of expert panels’ involvement	N/A
24	Reimbursement	Slovakia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
24	Reimbursement	Slovakia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
25	General	Slovenia	EU	1	Link to the website of the procedure	https://www.jazmp.si/en/medical-devices/clinical-investigations/
25	Fee	Slovenia	EU	2	Fee (€)	I/IIa 3800 IIb/III 4175
25	Standard documentation to be submitted	Slovenia	EU	3a	Cover letter	N/A
25	Standard documentation to be submitted	Slovenia	EU	3b	Authorisation/application form	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3c	Investigator's Brochure	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3f	Case Report Form (CRF)	N/A
25	Standard documentation to be submitted	Slovenia	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3h	Proof of insurance cover	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3j	Proof of payment of the fee	N/A
25	Standard documentation to be submitted	Slovenia	EU	3k	Opinion of experts’ panels	N/A
25	Standard documentation to be submitted	Slovenia	EU	3l	CE certificates of Notified Bodies	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3m	Decisions of other Competent Authorities concerned	N/A
25	Standard documentation to be submitted	Slovenia	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3o	Recruitment procedures and advertising materials	N/A
25	Standard documentation to be submitted	Slovenia	EU	3p	Opinion of other Ethics Committees concerned	N/A
25	Standard documentation to be submitted	Slovenia	EU	3q	General Device Information	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3r	Medicinal products contained in the device	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3s	List of participating countries	N/A
25	Standard documentation to be submitted	Slovenia	EU	3t	Trial centres list	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3u	Declaration of possession of requirements for trial centres	N/A
25	Standard documentation to be submitted	Slovenia	EU	3v	Compliance to ISO 14155	Yes, mandatory
25	Standard documentation to be submitted	Slovenia	EU	3w	MRI checklist	N/A
25	Standard documentation to be submitted	Slovenia	EU	3x	Ionising radiation information	N/A
25	Standard documentation to be submitted	Slovenia	EU	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
25	Patients' involvement	Slovenia	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
25	Patients' involvement	Slovenia	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
25	Patients' involvement	Slovenia	EU	4b	Timing of patients’ involvement	N/A
25	HTA involvement	Slovenia	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
25	HTA involvement	Slovenia	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
25	HTA involvement	Slovenia	EU	5b	Timing of HTA bodies’ involvement	N/A
25	Expert involvement	Slovenia	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
25	Expert involvement	Slovenia	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
25	Expert involvement	Slovenia	EU	6b	Timing of expert panels’ involvement	N/A
25	Reimbursement	Slovenia	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
25	Reimbursement	Slovenia	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
26	General	Spain	EU	1	Link to the website of the procedure	https://www.aemps.gob.es/productos-sanitarios/investigacionclinica-productossanitarios/instrucciones-de-la-aemps-para-la-realizacion-de-investigaciones-clinicas-con-productos-sanitarios-en-espana/
26	Fee	Spain	EU	2	Fee (€)	1554
26	Standard documentation to be submitted	Spain	EU	3a	Cover letter	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3b	Authorisation/application form	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3c	Investigator's Brochure	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3f	Case Report Form (CRF)	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3h	Proof of insurance cover	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
26	Standard documentation to be submitted	Spain	EU	3j	Proof of payment of the fee	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3k	Opinion of experts’ panels	N/A
26	Standard documentation to be submitted	Spain	EU	3l	CE certificates of Notified Bodies	N/A
26	Standard documentation to be submitted	Spain	EU	3m	Decisions of other Competent Authorities concerned	No
26	Standard documentation to be submitted	Spain	EU	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
26	Standard documentation to be submitted	Spain	EU	3o	Recruitment procedures and advertising materials	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3p	Opinion of other Ethics Committees concerned	No
26	Standard documentation to be submitted	Spain	EU	3q	General Device Information	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3r	Medicinal products contained in the device	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3s	List of participating countries	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3t	Declaration of possession of requirements for trial centres	Yes, optional
26	Standard documentation to be submitted	Spain	EU	3u	Trial centres list	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3v	Compliance to ISO 14155	No
26	Standard documentation to be submitted	Spain	EU	3w	MRI checklist	No
26	Standard documentation to be submitted	Spain	EU	3x	Ionising radiation information	Yes, mandatory
26	Standard documentation to be submitted	Spain	EU	3y	Serious Adverse Event (SAE) Report Form	No
26	Patients' involvement	Spain	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
26	Patients' involvement	Spain	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
26	Patients' involvement	Spain	EU	4b	Timing of patients’ involvement	N/A
26	HTA involvement	Spain	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
26	HTA involvement	Spain	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
26	HTA involvement	Spain	EU	5b	Timing of HTA bodies’ involvement	N/A
26	Expert involvement	Spain	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
26	Expert involvement	Spain	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
26	Expert involvement	Spain	EU	6b	Timing of expert panels’ involvement	N/A
26	Reimbursement	Spain	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
26	Reimbursement	Spain	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
27	General	Sweden	EU	1	Link to the website of the procedure	N/A
27	Fee	Sweden	EU	2	Fee (€)	I/non-invasive IIa/IIb 2150 III/invasive IIa/IIb 5160
27	Standard documentation to be submitted	Sweden	EU	3a	Cover letter	N/A
27	Standard documentation to be submitted	Sweden	EU	3b	Authorisation/application form	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3c	Investigator's Brochure	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3e	Copy of the opinion of the ethics committee	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3f	Case Report Form (CRF)	N/A
27	Standard documentation to be submitted	Sweden	EU	3g	Informed Consent Form (ICF)	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3h	Proof of insurance cover	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3j	Proof of payment of the fee	Yes, mandatory
27	Standard documentation to be submitted	Sweden	EU	3k	Opinion of experts’ panels	N/A
27	Standard documentation to be submitted	Sweden	EU	3l	CE certificates of Notified Bodies	N/A
27	Standard documentation to be submitted	Sweden	EU	3m	Decisions of other Competent Authorities concerned	N/A
27	Standard documentation to be submitted	Sweden	EU	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
27	Standard documentation to be submitted	Sweden	EU	3o	Recruitment procedures and advertising materials	N/A
27	Standard documentation to be submitted	Sweden	EU	3p	Opinion of other Ethics Committees concerned	N/A
27	Standard documentation to be submitted	Sweden	EU	3q	General Device Information	N/A
27	Standard documentation to be submitted	Sweden	EU	3r	Medicinal products contained in the device	N/A
27	Standard documentation to be submitted	Sweden	EU	3s	List of participating countries	N/A
27	Standard documentation to be submitted	Sweden	EU	3t	Trial centres list	N/A
27	Standard documentation to be submitted	Sweden	EU	3u	Declaration of possession of requirements for trial centres	N/A
27	Standard documentation to be submitted	Sweden	EU	3v	Compliance to ISO 14155	N/A
27	Standard documentation to be submitted	Sweden	EU	3w	MRI checklist	N/A
27	Standard documentation to be submitted	Sweden	EU	3x	Ionising radiation information	N/A
27	Standard documentation to be submitted	Sweden	EU	3y	Serious Adverse Event (SAE) Report Form	N/A
27	Patients' involvement	Sweden	EU	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
27	Patients' involvement	Sweden	EU	4a	Brief description of the type and extent of patients’ involvement	N/A
27	Patients' involvement	Sweden	EU	4b	Timing of patients’ involvement	N/A
27	HTA involvement	Sweden	EU	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
27	HTA involvement	Sweden	EU	5a	Brief description of the type and extent of HTA bodies involvement	N/A
27	HTA involvement	Sweden	EU	5b	Timing of HTA bodies’ involvement	N/A
27	Expert involvement	Sweden	EU	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
27	Expert involvement	Sweden	EU	6a	Brief description of the type and extent of expert panels’ involvement	N/A
27	Expert involvement	Sweden	EU	6b	Timing of expert panels’ involvement	N/A
27	Reimbursement	Sweden	EU	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
27	Reimbursement	Sweden	EU	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
28	General	Iceland	EEA	1	Link to the website of the procedure	https://www.lyfjastofnun.is/laekningataeki/kliniskar-profanir-a-laekningataekjum/
28	Fee	Iceland	EEA	2	Fee (€)	N/A
28	Standard documentation to be submitted	Iceland	EEA	3a	Cover letter	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3b	Authorisation/application form	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3c	Investigator's Brochure	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3f	Case Report Form (CRF)	N/A
28	Standard documentation to be submitted	Iceland	EEA	3g	Informed Consent Form (ICF)	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3h	Proof of insurance cover	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3j	Proof of payment of the fee	N/A
28	Standard documentation to be submitted	Iceland	EEA	3k	Opinion of experts’ panels	N/A
28	Standard documentation to be submitted	Iceland	EEA	3l	CE certificates of Notified Bodies	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3m	Decisions of other Competent Authorities concerned	N/A
28	Standard documentation to be submitted	Iceland	EEA	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3o	Recruitment procedures and advertising materials	N/A
28	Standard documentation to be submitted	Iceland	EEA	3p	Opinion of other Ethics Committees concerned	N/A
28	Standard documentation to be submitted	Iceland	EEA	3q	General Device Information	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3r	Medicinal products contained in the device	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3s	List of participating countries	N/A
28	Standard documentation to be submitted	Iceland	EEA	3t	Trial centres list	Yes, mandatory
28	Standard documentation to be submitted	Iceland	EEA	3u	Declaration of possession of requirements for trial centres	N/A
28	Standard documentation to be submitted	Iceland	EEA	3v	Compliance to ISO 14155	N/A
28	Standard documentation to be submitted	Iceland	EEA	3w	MRI checklist	N/A
28	Standard documentation to be submitted	Iceland	EEA	3x	Ionising radiation information	N/A
28	Standard documentation to be submitted	Iceland	EEA	3y	Serious Adverse Event (SAE) Report Form	N/A
28	Patients' involvement	Iceland	EEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
28	Patients' involvement	Iceland	EEA	4a	Brief description of the type and extent of patients’ involvement	N/A
28	Patients' involvement	Iceland	EEA	4b	Timing of patients’ involvement	N/A
28	HTA involvement	Iceland	EEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
28	HTA involvement	Iceland	EEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
28	HTA involvement	Iceland	EEA	5b	Timing of HTA bodies’ involvement	N/A
28	Expert involvement	Iceland	EEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
28	Expert involvement	Iceland	EEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
28	Expert involvement	Iceland	EEA	6b	Timing of expert panels’ involvement	N/A
28	Reimbursement	Iceland	EEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
28	Reimbursement	Iceland	EEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
29	General	Liechtenstein	EEA	1	Link to the website of the procedure	https://www.llv.li/en/company/industry-professional-associations/health-professions-and-healing/medical-devices-in-vitro-diagnostics/clinical-exams
29	Fee	Liechtenstein	EEA	2	Fee (€)	5312
29	Standard documentation to be submitted	Liechtenstein	EEA	3a	Cover letter	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3b	Authorisation/application form	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3c	Investigator's Brochure	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3f	Case Report Form (CRF)	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3g	Informed Consent Form (ICF)	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3h	Proof of insurance cover	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3j	Proof of payment of the fee	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3k	Opinion of experts’ panels	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3l	CE certificates of Notified Bodies	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3m	Decisions of other Competent Authorities concerned	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3o	Recruitment procedures and advertising materials	No
29	Standard documentation to be submitted	Liechtenstein	EEA	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3q	General Device Information	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3r	Medicinal products contained in the device	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3s	List of participating countries	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3t	Trial centres list	Yes, mandatory
29	Standard documentation to be submitted	Liechtenstein	EEA	3u	Declaration of possession of requirements for trial centres	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3v	Compliance to ISO 14155	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3w	MRI checklist	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3x	Ionising radiation information	N/A
29	Standard documentation to be submitted	Liechtenstein	EEA	3y	Serious Adverse Event (SAE) Report Form	N/A
29	Patients' involvement	Liechtenstein	EEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
29	Patients' involvement	Liechtenstein	EEA	4a	Brief description of the type and extent of patients’ involvement	N/A
29	Patients' involvement	Liechtenstein	EEA	4b	Timing of patients’ involvement	N/A
29	HTA involvement	Liechtenstein	EEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
29	HTA involvement	Liechtenstein	EEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
29	HTA involvement	Liechtenstein	EEA	5b	Timing of HTA bodies’ involvement	N/A
29	Expert involvement	Liechtenstein	EEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
29	Expert involvement	Liechtenstein	EEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
29	Expert involvement	Liechtenstein	EEA	6b	Timing of expert panels’ involvement	N/A
29	Reimbursement	Liechtenstein	EEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
29	Reimbursement	Liechtenstein	EEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
30	General	Norway	EEA	1	Link to the website of the procedure	https://www.dmp.no/en/medical-devices/clinical-investigation-of-medical-devices/clinical-investigations-which-require-a-notification-to-noma
30	Fee	Norway	EEA	2	Fee (€)	N/A
30	Standard documentation to be submitted	Norway	EEA	3a	Cover letter	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3b	Authorisation/application form	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3c	Investigator's Brochure	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3f	Case Report Form (CRF)	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3g	Informed Consent Form (ICF)	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3h	Proof of insurance cover	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3j	Proof of payment of the fee	N/A
30	Standard documentation to be submitted	Norway	EEA	3k	Opinion of experts’ panels	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3l	CE certificates of Notified Bodies	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3m	Decisions of other Competent Authorities concerned	N/A
30	Standard documentation to be submitted	Norway	EEA	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3o	Recruitment procedures and advertising materials	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3q	General Device Information	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3r	Medicinal products contained in the device	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3s	List of participating countries	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3t	Trial centres list	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3v	Compliance to ISO 14155	Yes, mandatory
30	Standard documentation to be submitted	Norway	EEA	3w	MRI checklist	N/A
30	Standard documentation to be submitted	Norway	EEA	3x	Ionising radiation information	N/A
30	Standard documentation to be submitted	Norway	EEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
30	Patients' involvement	Norway	EEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
30	Patients' involvement	Norway	EEA	4a	Brief description of the type and extent of patients’ involvement	No
30	Patients' involvement	Norway	EEA	4b	Timing of patients’ involvement	No
30	HTA involvement	Norway	EEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
30	HTA involvement	Norway	EEA	5a	Brief description of the type and extent of HTA bodies involvement	No
30	HTA involvement	Norway	EEA	5b	Timing of HTA bodies’ involvement	No
30	Expert involvement	Norway	EEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	Yes, optional
30	Expert involvement	Norway	EEA	6a	Brief description of the type and extent of expert panels’ involvement	The sponsor has the option to seek Scientific Advice from the MDR EMA Expert Panels, and NOMA will ask whether this has been done. NOMA states that they can involve national spesialists in the field when they deem neccessary.
30	Expert involvement	Norway	EEA	6b	Timing of expert panels’ involvement	No
30	Reimbursement	Norway	EEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
30	Reimbursement	Norway	EEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
31	General	Albania	EMEA	1	Link to the website of the procedure	https://akbpm.gov.al/wp-content/uploads/2019/08/Ligji-i-pajisjeve-mjekesore-2.pdf
31	Fee	Albania	EMEA	2	Fee (€)	5
31	Standard documentation to be submitted	Albania	EMEA	3a	Cover letter	No
31	Standard documentation to be submitted	Albania	EMEA	3b	Authorisation/application form	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3c	Investigator's Brochure	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3f	Case Report Form (CRF)	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3g	Informed Consent Form (ICF)	N/A
31	Standard documentation to be submitted	Albania	EMEA	3h	Proof of insurance cover	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3j	Proof of payment of the fee	No
31	Standard documentation to be submitted	Albania	EMEA	3k	Opinion of experts’ panels	No
31	Standard documentation to be submitted	Albania	EMEA	3l	CE certificates of Notified Bodies	Yes, optional
31	Standard documentation to be submitted	Albania	EMEA	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
31	Standard documentation to be submitted	Albania	EMEA	3o	Recruitment procedures and advertising materials	N/A
31	Standard documentation to be submitted	Albania	EMEA	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3q	General Device Information	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3s	List of participating countries	N/A
31	Standard documentation to be submitted	Albania	EMEA	3t	Trial centres list	Yes, mandatory
31	Standard documentation to be submitted	Albania	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
31	Standard documentation to be submitted	Albania	EMEA	3v	Compliance to ISO 14155	N/A
31	Standard documentation to be submitted	Albania	EMEA	3w	MRI checklist	N/A
31	Standard documentation to be submitted	Albania	EMEA	3x	Ionising radiation information	N/A
31	Standard documentation to be submitted	Albania	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
31	Patients' involvement	Albania	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
31	Patients' involvement	Albania	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
31	Patients' involvement	Albania	EMEA	4b	Timing of patients’ involvement	N/A
31	HTA involvement	Albania	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
31	HTA involvement	Albania	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
31	HTA involvement	Albania	EMEA	5b	Timing of HTA bodies’ involvement	N/A
31	Expert involvement	Albania	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
31	Expert involvement	Albania	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
31	Expert involvement	Albania	EMEA	6b	Timing of expert panels’ involvement	N/A
31	Reimbursement	Albania	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
31	Reimbursement	Albania	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
32	General	Georgia	EMEA	1	Link to the website of the procedure	N/A
32	Fee	Georgia	EMEA	2	Fee (€)	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3a	Cover letter	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3b	Authorisation/application form	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3c	Investigator's Brochure	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3e	Copy of the opinion of the ethics committee	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3f	Case Report Form (CRF)	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3h	Proof of insurance cover	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3j	Proof of payment of the fee	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3k	Opinion of experts’ panels	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3l	CE certificates of Notified Bodies	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3o	Recruitment procedures and advertising materials	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3q	General Device Information	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3r	Medicinal products contained in the device	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3s	List of participating countries	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3t	Trial centres list	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
32	Standard documentation to be submitted	Georgia	EMEA	3v	Compliance to ISO 14155	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3w	MRI checklist	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3x	Ionising radiation information	N/A
32	Standard documentation to be submitted	Georgia	EMEA	3y	Serious Adverse Event (SAE) Report Form	N/A
32	Patients' involvement	Georgia	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
32	Patients' involvement	Georgia	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
32	Patients' involvement	Georgia	EMEA	4b	Timing of patients’ involvement	N/A
32	HTA involvement	Georgia	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
32	HTA involvement	Georgia	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
32	HTA involvement	Georgia	EMEA	5b	Timing of HTA bodies’ involvement	N/A
32	Expert involvement	Georgia	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
32	Expert involvement	Georgia	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
32	Expert involvement	Georgia	EMEA	6b	Timing of expert panels’ involvement	N/A
32	Reimbursement	Georgia	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
32	Reimbursement	Georgia	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
33	General	Israel	EMEA	1	Link to the website of the procedure	https://www.gov.il/BlobFolder/generalpage/ct-roadmap/he/units_clinical-trials_roadmap.pdf
33	Fee	Israel	EMEA	2	Fee (€)	No fee
33	Standard documentation to be submitted	Israel	EMEA	3a	Cover letter	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3b	Authorisation/application form	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3c	Investigator's Brochure	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3f	Case Report Form (CRF)	No
33	Standard documentation to be submitted	Israel	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3h	Proof of insurance cover	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
33	Standard documentation to be submitted	Israel	EMEA	3j	Proof of payment of the fee	N/A
33	Standard documentation to be submitted	Israel	EMEA	3k	Opinion of experts’ panels	No
33	Standard documentation to be submitted	Israel	EMEA	3l	CE certificates of Notified Bodies	No
33	Standard documentation to be submitted	Israel	EMEA	3m	Decisions of other Competent Authorities concerned	No
33	Standard documentation to be submitted	Israel	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	No
33	Standard documentation to be submitted	Israel	EMEA	3o	Recruitment procedures and advertising materials	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3p	Opinion of other Ethics Committees concerned	No
33	Standard documentation to be submitted	Israel	EMEA	3q	General Device Information	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3s	List of participating countries	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3t	Trial centres list	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3u	Declaration of possession of requirements for trial centres	No
33	Standard documentation to be submitted	Israel	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
33	Standard documentation to be submitted	Israel	EMEA	3w	MRI checklist	No
33	Standard documentation to be submitted	Israel	EMEA	3x	Ionising radiation information	No
33	Standard documentation to be submitted	Israel	EMEA	3y	Serious Adverse Event (SAE) Report Form	No
33	Patients' involvement	Israel	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
33	Patients' involvement	Israel	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
33	Patients' involvement	Israel	EMEA	4b	Timing of patients’ involvement	N/A
33	HTA involvement	Israel	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
33	HTA involvement	Israel	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
33	HTA involvement	Israel	EMEA	5b	Timing of HTA bodies’ involvement	N/A
33	Expert involvement	Israel	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
33	Expert involvement	Israel	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
33	Expert involvement	Israel	EMEA	6b	Timing of expert panels’ involvement	N/A
33	Reimbursement	Israel	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
33	Reimbursement	Israel	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
34	General	Kazakhstan	EMEA	1	Link to the website of the procedure	https://adilet.zan.kz/kaz/docs/V2000021772#z10
34	Fee	Kazakhstan	EMEA	2	Fee (€)	No fee
34	Standard documentation to be submitted	Kazakhstan	EMEA	3a	Cover letter	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3b	Authorisation/application form	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3c	Investigator's Brochure	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3f	Case Report Form (CRF)	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3h	Proof of insurance cover	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3j	Proof of payment of the fee	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3k	Opinion of experts’ panels	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3l	CE certificates of Notified Bodies	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3o	Recruitment procedures and advertising materials	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3q	General Device Information	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3s	List of participating countries	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3t	Trial centres list	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
34	Standard documentation to be submitted	Kazakhstan	EMEA	3w	MRI checklist	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3x	Ionising radiation information	N/A
34	Standard documentation to be submitted	Kazakhstan	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
34	Patients' involvement	Kazakhstan	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
34	Patients' involvement	Kazakhstan	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
34	Patients' involvement	Kazakhstan	EMEA	4b	Timing of patients’ involvement	N/A
34	HTA involvement	Kazakhstan	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
34	HTA involvement	Kazakhstan	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
34	HTA involvement	Kazakhstan	EMEA	5b	Timing of HTA bodies’ involvement	N/A
34	Expert involvement	Kazakhstan	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
34	Expert involvement	Kazakhstan	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
34	Expert involvement	Kazakhstan	EMEA	6b	Timing of expert panels’ involvement	N/A
34	Reimbursement	Kazakhstan	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
34	Reimbursement	Kazakhstan	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
35	General	Russia	EMEA	1	Link to the website of the procedure	https://docs.cntd.ru/document/1200110952
35	Fee	Russia	EMEA	2	Fee (€)	Depends on medical device, insurance, cost of the clinic, samples.
35	Standard documentation to be submitted	Russia	EMEA	3a	Cover letter	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3b	Authorisation/application form	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3c	Investigator's Brochure	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3f	Case Report Form (CRF)	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3h	Proof of insurance cover	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3j	Proof of payment of the fee	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3k	Opinion of experts’ panels	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3l	CE certificates of Notified Bodies	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3m	Decisions of other Competent Authorities concerned	Yes, optional
35	Standard documentation to be submitted	Russia	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3o	Recruitment procedures and advertising materials	No
35	Standard documentation to be submitted	Russia	EMEA	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3q	General Device Information	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3s	List of participating countries	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3t	Trial centres list	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3w	MRI checklist	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3x	Ionising radiation information	Yes, mandatory
35	Standard documentation to be submitted	Russia	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
35	Patients' involvement	Russia	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
35	Patients' involvement	Russia	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
35	Patients' involvement	Russia	EMEA	4b	Timing of patients’ involvement	N/A
35	HTA involvement	Russia	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
35	HTA involvement	Russia	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
35	HTA involvement	Russia	EMEA	5b	Timing of HTA bodies’ involvement	N/A
35	Expert involvement	Russia	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
35	Expert involvement	Russia	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
35	Expert involvement	Russia	EMEA	6b	Timing of expert panels’ involvement	N/A
35	Reimbursement	Russia	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
35	Reimbursement	Russia	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
36	General	Saudi Arabia	EMEA	1	Link to the website of the procedure	https://sfda.gov.sa/en/regulations/66129
36	Fee	Saudi Arabia	EMEA	2	Fee (€)	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3a	Cover letter	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3b	Authorisation/application form	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3c	Investigator's Brochure	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3f	Case Report Form (CRF)	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3h	Proof of insurance cover	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3j	Proof of payment of the fee	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3k	Opinion of experts’ panels	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3l	CE certificates of Notified Bodies	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3o	Recruitment procedures and advertising materials	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3q	General Device Information	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3s	List of participating countries	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3t	Trial centres list	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3w	MRI checklist	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3x	Ionising radiation information	N/A
36	Standard documentation to be submitted	Saudi Arabia	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
36	Patients' involvement	Saudi Arabia	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
36	Patients' involvement	Saudi Arabia	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
36	Patients' involvement	Saudi Arabia	EMEA	4b	Timing of patients’ involvement	N/A
36	HTA involvement	Saudi Arabia	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
36	HTA involvement	Saudi Arabia	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
36	HTA involvement	Saudi Arabia	EMEA	5b	Timing of HTA bodies’ involvement	N/A
36	Expert involvement	Saudi Arabia	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
36	Expert involvement	Saudi Arabia	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
36	Expert involvement	Saudi Arabia	EMEA	6b	Timing of expert panels’ involvement	N/A
36	Reimbursement	Saudi Arabia	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
36	Reimbursement	Saudi Arabia	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
37	Fee	South Africa	EMEA	1	Fee (€)	816
37	Standard documentation to be submitted	South Africa	EMEA	3	Standard documentation to be submitted:	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3a	Cover letter	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3b	Authorisation/application form	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3c	Investigator's Brochure	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3f	Case Report Form (CRF)	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3h	Proof of insurance cover	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3j	Proof of payment of the fee	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3k	Opinion of experts’ panels	Yes, optional
37	Standard documentation to be submitted	South Africa	EMEA	3l	CE certificates of Notified Bodies	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3o	Recruitment procedures and advertising materials	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3q	General Device Information	Yes, mandatory
37	Standard documentation to be submitted	South Africa	EMEA	3r	Medicinal products contained in the device	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3s	List of participating countries	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3t	Trial centres list	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3v	Compliance to ISO 14155	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3w	MRI checklist	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3x	Ionising radiation information	N/A
37	Standard documentation to be submitted	South Africa	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
37	Patients' involvement	South Africa	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
37	Patients' involvement	South Africa	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
37	Patients' involvement	South Africa	EMEA	4b	Timing of patients’ involvement	N/A
37	HTA involvement	South Africa	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
37	HTA involvement	South Africa	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
37	HTA involvement	South Africa	EMEA	5b	Timing of HTA bodies’ involvement	N/A
37	Expert involvement	South Africa	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
37	Expert involvement	South Africa	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
37	Expert involvement	South Africa	EMEA	6b	Timing of expert panels’ involvement	N/A
37	Reimbursement	South Africa	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
37	Reimbursement	South Africa	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
38	General	Switzerland	EMEA	1	Link to the website of the procedure	https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/klinische-pruefungen.html
38	Fee	Switzerland	EMEA	2	Fee (€)	5311
38	Standard documentation to be submitted	Switzerland	EMEA	3a	Cover letter	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3b	Authorisation/application form	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3c	Investigator's Brochure	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3e	Copy of the opinion of the ethics committee	Yes, optional
38	Standard documentation to be submitted	Switzerland	EMEA	3f	Case Report Form (CRF)	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3h	Proof of insurance cover	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
38	Standard documentation to be submitted	Switzerland	EMEA	3j	Proof of payment of the fee	N/A
38	Standard documentation to be submitted	Switzerland	EMEA	3k	Opinion of experts’ panels	No
38	Standard documentation to be submitted	Switzerland	EMEA	3l	CE certificates of Notified Bodies	Yes, optional
38	Standard documentation to be submitted	Switzerland	EMEA	3m	Decisions of other Competent Authorities concerned	Yes, optional
38	Standard documentation to be submitted	Switzerland	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	No
38	Standard documentation to be submitted	Switzerland	EMEA	3o	Recruitment procedures and advertising materials	No
38	Standard documentation to be submitted	Switzerland	EMEA	3p	Opinion of other Ethics Committees concerned	Yes, optional
38	Standard documentation to be submitted	Switzerland	EMEA	3q	General Device Information	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3s	List of participating countries	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3t	Trial centres list	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3u	Declaration of possession of requirements for trial centres	No
38	Standard documentation to be submitted	Switzerland	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3w	MRI checklist	No
38	Standard documentation to be submitted	Switzerland	EMEA	3x	Ionising radiation information	Yes, mandatory
38	Standard documentation to be submitted	Switzerland	EMEA	3y	Serious Adverse Event (SAE) Report Form	No
38	Patients' involvement	Switzerland	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
38	Patients' involvement	Switzerland	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
38	Patients' involvement	Switzerland	EMEA	4b	Timing of patients’ involvement	N/A
38	HTA involvement	Switzerland	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
38	HTA involvement	Switzerland	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
38	HTA involvement	Switzerland	EMEA	5b	Timing of HTA bodies’ involvement	N/A
38	Expert involvement	Switzerland	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
38	Expert involvement	Switzerland	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
38	Expert involvement	Switzerland	EMEA	6b	Timing of expert panels’ involvement	N/A
38	Reimbursement	Switzerland	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
38	Reimbursement	Switzerland	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
39	General	Tunisia	EMEA	1	Link to the website of the procedure	N/A
39	Fee	Tunisia	EMEA	2	Fee (€)	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3a	Cover letter	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3b	Authorisation/application form	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3c	Investigator's Brochure	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3d	Clinical Investigation Plan (CIP)	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3e	Copy of the opinion of the ethics committee	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3f	Case Report Form (CRF)	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3g	Informed Consent Form (ICF)	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3h	Proof of insurance cover	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3j	Proof of payment of the fee	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3k	Opinion of experts’ panels	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3l	CE certificates of Notified Bodies	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3o	Recruitment procedures and advertising materials	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3q	General Device Information	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3r	Medicinal products contained in the device	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3s	List of participating countries	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3t	Trial centres list	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3v	Compliance to ISO 14155	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3w	MRI checklist	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3x	Ionising radiation information	N/A
39	Standard documentation to be submitted	Tunisia	EMEA	3y	Serious Adverse Event (SAE) Report Form	N/A
39	Patients' involvement	Tunisia	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
39	Patients' involvement	Tunisia	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
39	Patients' involvement	Tunisia	EMEA	4b	Timing of patients’ involvement	N/A
39	HTA involvement	Tunisia	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
39	HTA involvement	Tunisia	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
39	HTA involvement	Tunisia	EMEA	5b	Timing of HTA bodies’ involvement	N/A
39	Expert involvement	Tunisia	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
39	Expert involvement	Tunisia	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
39	Expert involvement	Tunisia	EMEA	6b	Timing of expert panels’ involvement	N/A
39	Reimbursement	Tunisia	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
39	Reimbursement	Tunisia	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
40	Fee	Turkey	EMEA	1	Fee (€)	931
40	Standard documentation to be submitted	Turkey	EMEA	3	Standard documentation to be submitted:	N/A
40	Standard documentation to be submitted	Turkey	EMEA	3a	Cover letter	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3b	Authorisation/application form	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3c	Investigator's Brochure	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3f	Case Report Form (CRF)	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3h	Proof of insurance cover	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3j	Proof of payment of the fee	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3k	Opinion of experts’ panels	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3l	CE certificates of Notified Bodies	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3m	Decisions of other Competent Authorities concerned	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3o	Recruitment procedures and advertising materials	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3p	Opinion of other Ethics Committees concerned	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3q	General Device Information	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3r	Medicinal products contained in the device	No
40	Standard documentation to be submitted	Turkey	EMEA	3s	List of participating countries	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3t	Trial centres list	Yes, mandatory
40	Standard documentation to be submitted	Turkey	EMEA	3u	Declaration of possession of requirements for trial centres	No
40	Standard documentation to be submitted	Turkey	EMEA	3v	Compliance to ISO 14155	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3w	MRI checklist	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3x	Ionising radiation information	Yes, optional
40	Standard documentation to be submitted	Turkey	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
40	Patients' involvement	Turkey	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
40	Patients' involvement	Turkey	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
40	Patients' involvement	Turkey	EMEA	4b	Timing of patients’ involvement	N/A
40	HTA involvement	Turkey	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
40	HTA involvement	Turkey	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
40	HTA involvement	Turkey	EMEA	5b	Timing of HTA bodies’ involvement	N/A
40	Expert involvement	Turkey	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
40	Expert involvement	Turkey	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
40	Expert involvement	Turkey	EMEA	6b	Timing of expert panels’ involvement	N/A
40	Reimbursement	Turkey	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
40	Reimbursement	Turkey	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
41	General	UK	EMEA	1	Link to the website of the procedure	https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#overview
41	Fee	UK	EMEA	2	Fee (€)	I/IIa/IIb 8742 (resubmission 6677) IIb/invasive III 18284 (resubmission 12951)
41	Standard documentation to be submitted	UK	EMEA	3a	Cover letter	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3b	Authorisation/application form	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3c	Investigator's Brochure	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3f	Case Report Form (CRF)	N/A
41	Standard documentation to be submitted	UK	EMEA	3g	Informed Consent Form (ICF)	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3h	Proof of insurance cover	N/A
41	Standard documentation to be submitted	UK	EMEA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
41	Standard documentation to be submitted	UK	EMEA	3j	Proof of payment of the fee	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3k	Opinion of experts’ panels	No
41	Standard documentation to be submitted	UK	EMEA	3l	CE certificates of Notified Bodies	Yes, optional
41	Standard documentation to be submitted	UK	EMEA	3m	Decisions of other Competent Authorities concerned	N/A
41	Standard documentation to be submitted	UK	EMEA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
41	Standard documentation to be submitted	UK	EMEA	3o	Recruitment procedures and advertising materials	N/A
41	Standard documentation to be submitted	UK	EMEA	3p	Opinion of other Ethics Committees concerned	N/A
41	Standard documentation to be submitted	UK	EMEA	3q	General Device Information	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3r	Medicinal products contained in the device	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3s	List of participating countries	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3t	Trial centres list	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3u	Declaration of possession of requirements for trial centres	N/A
41	Standard documentation to be submitted	UK	EMEA	3v	Compliance to ISO 14155	Yes, mandatory
41	Standard documentation to be submitted	UK	EMEA	3w	MRI checklist	Yes, optional
41	Standard documentation to be submitted	UK	EMEA	3x	Ionising radiation information	Yes, optional
41	Standard documentation to be submitted	UK	EMEA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
41	Patients' involvement	UK	EMEA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
41	Patients' involvement	UK	EMEA	4a	Brief description of the type and extent of patients’ involvement	N/A
41	Patients' involvement	UK	EMEA	4b	Timing of patients’ involvement	N/A
41	HTA involvement	UK	EMEA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
41	HTA involvement	UK	EMEA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
41	HTA involvement	UK	EMEA	5b	Timing of HTA bodies’ involvement	N/A
41	Expert involvement	UK	EMEA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
41	Expert involvement	UK	EMEA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
41	Expert involvement	UK	EMEA	6b	Timing of expert panels’ involvement	N/A
41	Reimbursement	UK	EMEA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
41	Reimbursement	UK	EMEA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
42	General	Canada	NAFTA	1	Link to the website of the procedure	https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html
42	Fee	Canada	NAFTA	2	Fee (€)	No fee
42	Standard documentation to be submitted	Canada	NAFTA	3a	Cover letter	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3b	Authorisation/application form	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3c	Investigator's Brochure	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3e	Copy of the opinion of the ethics committee	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3f	Case Report Form (CRF)	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3g	Informed Consent Form (ICF)	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3h	Proof of insurance cover	No
42	Standard documentation to be submitted	Canada	NAFTA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
42	Standard documentation to be submitted	Canada	NAFTA	3j	Proof of payment of the fee	N/A
42	Standard documentation to be submitted	Canada	NAFTA	3k	Opinion of experts’ panels	N/A
42	Standard documentation to be submitted	Canada	NAFTA	3l	CE certificates of Notified Bodies	N/A
42	Standard documentation to be submitted	Canada	NAFTA	3m	Decisions of other Competent Authorities concerned	N/A
42	Standard documentation to be submitted	Canada	NAFTA	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
42	Standard documentation to be submitted	Canada	NAFTA	3o	Recruitment procedures and advertising materials	No
42	Standard documentation to be submitted	Canada	NAFTA	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3q	General Device Information	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3r	Medicinal products contained in the device	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3s	List of participating countries	No
42	Standard documentation to be submitted	Canada	NAFTA	3t	Trial centres list	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
42	Standard documentation to be submitted	Canada	NAFTA	3v	Compliance to ISO 14155	Yes, optional
42	Standard documentation to be submitted	Canada	NAFTA	3w	MRI checklist	Yes, optional
42	Standard documentation to be submitted	Canada	NAFTA	3x	Ionising radiation information	No
42	Standard documentation to be submitted	Canada	NAFTA	3y	Serious Adverse Event (SAE) Report Form	No
42	Patients' involvement	Canada	NAFTA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
42	Patients' involvement	Canada	NAFTA	4a	Brief description of the type and extent of patients’ involvement	N/A
42	Patients' involvement	Canada	NAFTA	4b	Timing of patients’ involvement	N/A
42	HTA involvement	Canada	NAFTA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
42	HTA involvement	Canada	NAFTA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
42	HTA involvement	Canada	NAFTA	5b	Timing of HTA bodies’ involvement	N/A
42	Expert involvement	Canada	NAFTA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
42	Expert involvement	Canada	NAFTA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
42	Expert involvement	Canada	NAFTA	6b	Timing of expert panels’ involvement	N/A
42	Reimbursement	Canada	NAFTA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
42	Reimbursement	Canada	NAFTA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
43	General	USA	NAFTA	1	Link to the website of the procedure	https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program
43	Fee	USA	NAFTA	2	Fee (€)	No fee
43	Standard documentation to be submitted	USA	NAFTA	3a	Cover letter	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3b	Authorisation/application form	Yes, optional
43	Standard documentation to be submitted	USA	NAFTA	3c	Investigator's Brochure	N/A
43	Standard documentation to be submitted	USA	NAFTA	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3e	Copy of the opinion of the ethics committee	No
43	Standard documentation to be submitted	USA	NAFTA	3f	Case Report Form (CRF)	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3g	Informed Consent Form (ICF)	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3h	Proof of insurance cover	No
43	Standard documentation to be submitted	USA	NAFTA	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3j	Proof of payment of the fee	N/A
43	Standard documentation to be submitted	USA	NAFTA	3k	Opinion of experts’ panels	N/A
43	Standard documentation to be submitted	USA	NAFTA	3l	CE certificates of Notified Bodies	No
43	Standard documentation to be submitted	USA	NAFTA	3m	Decisions of other Competent Authorities concerned	No
43	Standard documentation to be submitted	USA	NAFTA	3n	Post Market Clinical Follow-up (PMCF) plan	No
43	Standard documentation to be submitted	USA	NAFTA	3o	Recruitment procedures and advertising materials	No
43	Standard documentation to be submitted	USA	NAFTA	3p	Opinion of other Ethics Committees concerned	No
43	Standard documentation to be submitted	USA	NAFTA	3q	General Device Information	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3r	Medicinal products contained in the device	Yes, mandatory
43	Standard documentation to be submitted	USA	NAFTA	3s	List of participating countries	No
43	Standard documentation to be submitted	USA	NAFTA	3t	Trial centres list	Yes, optional
43	Standard documentation to be submitted	USA	NAFTA	3u	Declaration of possession of requirements for trial centres	No
43	Standard documentation to be submitted	USA	NAFTA	3v	Compliance to ISO 14155	Yes, optional
43	Standard documentation to be submitted	USA	NAFTA	3w	MRI checklist	N/A
43	Standard documentation to be submitted	USA	NAFTA	3x	Ionising radiation information	No
43	Standard documentation to be submitted	USA	NAFTA	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
43	Patients' involvement	USA	NAFTA	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
43	Patients' involvement	USA	NAFTA	4a	Brief description of the type and extent of patients’ involvement	Maybe be utilized to justify risks, endpoints. Also used in the development process to ensure anatomical considerations have been considered.
43	Patients' involvement	USA	NAFTA	4b	Timing of patients’ involvement	Pre-submission, during review
43	HTA involvement	USA	NAFTA	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
43	HTA involvement	USA	NAFTA	5a	Brief description of the type and extent of HTA bodies involvement	N/A
43	HTA involvement	USA	NAFTA	5b	Timing of HTA bodies’ involvement	N/A
43	Expert involvement	USA	NAFTA	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
43	Expert involvement	USA	NAFTA	6a	Brief description of the type and extent of expert panels’ involvement	N/A
43	Expert involvement	USA	NAFTA	6b	Timing of expert panels’ involvement	N/A
43	Reimbursement	USA	NAFTA	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	Yes
43	Reimbursement	USA	NAFTA	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	Three trial categories exist and FDA selects the approriate category (A, B or C). A is most novel and usually assigned to EFS trials. CMS (payer) can be engaged following IDE approval and IRB approval.
44	General	Argentina	LATAM	1	Link to the website of the procedure	https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-969-1997-42205/actualizacion
44	Fee	Argentina	LATAM	2	Fee (€)	No fee
44	Standard documentation to be submitted	Argentina	LATAM	3a	Cover letter	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3b	Authorisation/application form	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3c	Investigator's Brochure	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3e	Copy of the opinion of the ethics committee	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3f	Case Report Form (CRF)	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3g	Informed Consent Form (ICF)	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3h	Proof of insurance cover	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3j	Proof of payment of the fee	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3k	Opinion of experts’ panels	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3l	CE certificates of Notified Bodies	N/A
44	Standard documentation to be submitted	Argentina	LATAM	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3o	Recruitment procedures and advertising materials	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3q	General Device Information	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3r	Medicinal products contained in the device	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3s	List of participating countries	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3t	Trial centres list	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3v	Compliance to ISO 14155	No
44	Standard documentation to be submitted	Argentina	LATAM	3w	MRI checklist	No
44	Standard documentation to be submitted	Argentina	LATAM	3x	Ionising radiation information	Yes, mandatory
44	Standard documentation to be submitted	Argentina	LATAM	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
44	Patients' involvement	Argentina	LATAM	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
44	Patients' involvement	Argentina	LATAM	4a	Brief description of the type and extent of patients’ involvement	N/A
44	Patients' involvement	Argentina	LATAM	4b	Timing of patients’ involvement	N/A
44	HTA involvement	Argentina	LATAM	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
44	HTA involvement	Argentina	LATAM	5a	Brief description of the type and extent of HTA bodies involvement	N/A
44	HTA involvement	Argentina	LATAM	5b	Timing of HTA bodies’ involvement	N/A
44	Expert involvement	Argentina	LATAM	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
44	Expert involvement	Argentina	LATAM	6a	Brief description of the type and extent of expert panels’ involvement	N/A
44	Expert involvement	Argentina	LATAM	6b	Timing of expert panels’ involvement	N/A
44	Reimbursement	Argentina	LATAM	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
44	Reimbursement	Argentina	LATAM	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
45	General	Brazil	LATAM	1	Link to the website of the procedure	https://antigo.anvisa.gov.br/documents/10181/6478920/RDC_837_2023_.pdf/d76982bf-db7c-43c8-9e1f-35b3c1bee159
45	Fee	Brazil	LATAM	2	Fee (€)	No fee
45	Standard documentation to be submitted	Brazil	LATAM	3a	Cover letter	N/A
45	Standard documentation to be submitted	Brazil	LATAM	3b	Authorisation/application form	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3c	Investigator's Brochure	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3e	Copy of the opinion of the ethics committee	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3f	Case Report Form (CRF)	No
45	Standard documentation to be submitted	Brazil	LATAM	3g	Informed Consent Form (ICF)	No
45	Standard documentation to be submitted	Brazil	LATAM	3h	Proof of insurance cover	No
45	Standard documentation to be submitted	Brazil	LATAM	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3j	Proof of payment of the fee	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3k	Opinion of experts’ panels	N/A
45	Standard documentation to be submitted	Brazil	LATAM	3l	CE certificates of Notified Bodies	N/A
45	Standard documentation to be submitted	Brazil	LATAM	3m	Decisions of other Competent Authorities concerned	No
45	Standard documentation to be submitted	Brazil	LATAM	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
45	Standard documentation to be submitted	Brazil	LATAM	3o	Recruitment procedures and advertising materials	No
45	Standard documentation to be submitted	Brazil	LATAM	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3q	General Device Information	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3r	Medicinal products contained in the device	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3s	List of participating countries	No
45	Standard documentation to be submitted	Brazil	LATAM	3t	Trial centres list	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3v	Compliance to ISO 14155	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3w	MRI checklist	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3x	Ionising radiation information	Yes, mandatory
45	Standard documentation to be submitted	Brazil	LATAM	3y	Serious Adverse Event (SAE) Report Form	No
45	Patients' involvement	Brazil	LATAM	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
45	Patients' involvement	Brazil	LATAM	4a	Brief description of the type and extent of patients’ involvement	N/A
45	Patients' involvement	Brazil	LATAM	4b	Timing of patients’ involvement	N/A
45	HTA involvement	Brazil	LATAM	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
45	HTA involvement	Brazil	LATAM	5a	Brief description of the type and extent of HTA bodies involvement	N/A
45	HTA involvement	Brazil	LATAM	5b	Timing of HTA bodies’ involvement	N/A
45	Expert involvement	Brazil	LATAM	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
45	Expert involvement	Brazil	LATAM	6a	Brief description of the type and extent of expert panels’ involvement	N/A
45	Expert involvement	Brazil	LATAM	6b	Timing of expert panels’ involvement	N/A
45	Reimbursement	Brazil	LATAM	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
45	Reimbursement	Brazil	LATAM	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
46	General	Chile	LATAM	1	Link to the website of the procedure	https://www.bcn.cl/leychile/navegar?idNorma=5595&idParte= https://www.ispch.gob.cl/anamed/estudios-clinicos/
46	Fee	Chile	LATAM	2	Fee (€)	900-2700
46	Standard documentation to be submitted	Chile	LATAM	3a	Cover letter	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3b	Authorisation/application form	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3c	Investigator's Brochure	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3e	Copy of the opinion of the ethics committee	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3f	Case Report Form (CRF)	No
46	Standard documentation to be submitted	Chile	LATAM	3g	Informed Consent Form (ICF)	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3h	Proof of insurance cover	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
46	Standard documentation to be submitted	Chile	LATAM	3j	Proof of payment of the fee	No
46	Standard documentation to be submitted	Chile	LATAM	3k	Opinion of experts’ panels	N/A
46	Standard documentation to be submitted	Chile	LATAM	3l	CE certificates of Notified Bodies	N/A
46	Standard documentation to be submitted	Chile	LATAM	3m	Decisions of other Competent Authorities concerned	No
46	Standard documentation to be submitted	Chile	LATAM	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
46	Standard documentation to be submitted	Chile	LATAM	3o	Recruitment procedures and advertising materials	No
46	Standard documentation to be submitted	Chile	LATAM	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3q	General Device Information	No
46	Standard documentation to be submitted	Chile	LATAM	3r	Medicinal products contained in the device	No
46	Standard documentation to be submitted	Chile	LATAM	3s	List of participating countries	Yes, mandatory
46	Standard documentation to be submitted	Chile	LATAM	3t	Trial centres list	No
46	Standard documentation to be submitted	Chile	LATAM	3u	Declaration of possession of requirements for trial centres	No
46	Standard documentation to be submitted	Chile	LATAM	3v	Compliance to ISO 14155	No
46	Standard documentation to be submitted	Chile	LATAM	3w	MRI checklist	No
46	Standard documentation to be submitted	Chile	LATAM	3x	Ionising radiation information	No
46	Standard documentation to be submitted	Chile	LATAM	3y	Serious Adverse Event (SAE) Report Form	No
46	Patients' involvement	Chile	LATAM	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
46	Patients' involvement	Chile	LATAM	4a	Brief description of the type and extent of patients’ involvement	N/A
46	Patients' involvement	Chile	LATAM	4b	Timing of patients’ involvement	N/A
46	HTA involvement	Chile	LATAM	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
46	HTA involvement	Chile	LATAM	5a	Brief description of the type and extent of HTA bodies involvement	N/A
46	HTA involvement	Chile	LATAM	5b	Timing of HTA bodies’ involvement	N/A
46	Expert involvement	Chile	LATAM	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
46	Expert involvement	Chile	LATAM	6a	Brief description of the type and extent of expert panels’ involvement	N/A
46	Expert involvement	Chile	LATAM	6b	Timing of expert panels’ involvement	N/A
46	Reimbursement	Chile	LATAM	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
46	Reimbursement	Chile	LATAM	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
47	General	Colombia	LATAM	1	Link to the website of the procedure	https://app.invima.gov.co/ovirtual/
47	Fee	Colombia	LATAM	2	Fee (€)	3341
47	Standard documentation to be submitted	Colombia	LATAM	3a	Cover letter	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3b	Authorisation/application form	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3c	Investigator's Brochure	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3d	Clinical Investigation Plan (CIP)	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3e	Copy of the opinion of the ethics committee	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3f	Case Report Form (CRF)	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3g	Informed Consent Form (ICF)	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3h	Proof of insurance cover	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3j	Proof of payment of the fee	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3k	Opinion of experts’ panels	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3l	CE certificates of Notified Bodies	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3m	Decisions of other Competent Authorities concerned	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3o	Recruitment procedures and advertising materials	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3q	General Device Information	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3r	Medicinal products contained in the device	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3s	List of participating countries	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3t	Trial centres list	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
47	Standard documentation to be submitted	Colombia	LATAM	3v	Compliance to ISO 14155	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3w	MRI checklist	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3x	Ionising radiation information	N/A
47	Standard documentation to be submitted	Colombia	LATAM	3y	Serious Adverse Event (SAE) Report Form	N/A
47	Patients' involvement	Colombia	LATAM	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
47	Patients' involvement	Colombia	LATAM	4a	Brief description of the type and extent of patients’ involvement	N/A
47	Patients' involvement	Colombia	LATAM	4b	Timing of patients’ involvement	N/A
47	HTA involvement	Colombia	LATAM	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
47	HTA involvement	Colombia	LATAM	5a	Brief description of the type and extent of HTA bodies involvement	N/A
47	HTA involvement	Colombia	LATAM	5b	Timing of HTA bodies’ involvement	N/A
47	Expert involvement	Colombia	LATAM	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
47	Expert involvement	Colombia	LATAM	6a	Brief description of the type and extent of expert panels’ involvement	N/A
47	Expert involvement	Colombia	LATAM	6b	Timing of expert panels’ involvement	N/A
47	Reimbursement	Colombia	LATAM	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
47	Reimbursement	Colombia	LATAM	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
48	General	Paraguay	LATAM	1	Link to the website of the procedure	https://dinavisa.gov.py/wp-content/uploads/2023/09/Requisitos-de-Ensayos-Clinicos.pdf
48	Fee	Paraguay	LATAM	2	Fee (€)	900-2700
48	Standard documentation to be submitted	Paraguay	LATAM	3a	Cover letter	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3b	Authorisation/application form	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3c	Investigator's Brochure	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3e	Copy of the opinion of the ethics committee	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3f	Case Report Form (CRF)	No
48	Standard documentation to be submitted	Paraguay	LATAM	3g	Informed Consent Form (ICF)	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3h	Proof of insurance cover	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
48	Standard documentation to be submitted	Paraguay	LATAM	3j	Proof of payment of the fee	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3k	Opinion of experts’ panels	No
48	Standard documentation to be submitted	Paraguay	LATAM	3l	CE certificates of Notified Bodies	No
48	Standard documentation to be submitted	Paraguay	LATAM	3m	Decisions of other Competent Authorities concerned	No
48	Standard documentation to be submitted	Paraguay	LATAM	3n	Post Market Clinical Follow-up (PMCF) plan	No
48	Standard documentation to be submitted	Paraguay	LATAM	3o	Recruitment procedures and advertising materials	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3q	General Device Information	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3r	Medicinal products contained in the device	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3s	List of participating countries	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3t	Trial centres list	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3v	Compliance to ISO 14155	No
48	Standard documentation to be submitted	Paraguay	LATAM	3w	MRI checklist	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3x	Ionising radiation information	Yes, mandatory
48	Standard documentation to be submitted	Paraguay	LATAM	3y	Serious Adverse Event (SAE) Report Form	No
48	Patients' involvement	Paraguay	LATAM	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
48	Patients' involvement	Paraguay	LATAM	4a	Brief description of the type and extent of patients’ involvement	N/A
48	Patients' involvement	Paraguay	LATAM	4b	Timing of patients’ involvement	N/A
48	HTA involvement	Paraguay	LATAM	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
48	HTA involvement	Paraguay	LATAM	5a	Brief description of the type and extent of HTA bodies involvement	N/A
48	HTA involvement	Paraguay	LATAM	5b	Timing of HTA bodies’ involvement	N/A
48	Expert involvement	Paraguay	LATAM	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
48	Expert involvement	Paraguay	LATAM	6a	Brief description of the type and extent of expert panels’ involvement	N/A
48	Expert involvement	Paraguay	LATAM	6b	Timing of expert panels’ involvement	N/A
48	Reimbursement	Paraguay	LATAM	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
48	Reimbursement	Paraguay	LATAM	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
49	General	Australia	APAC	1	Link to the website of the procedure	CTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor and sent to TGA via clinical.trials@health.gov.au . Supporting data for the CTA application should be provided in electronic format. It is preferable for data to be sent on USB or CD-ROM via post. In regard to supporting documents TGA evaluate summary information about the product including relevant, but limited, scientific data (which may be preclinical and early clinical data) prior to the start of a trial. If you are considering submitting a CTA application, you are strongly encouraged to contact the TGA for advice regarding the application process.
49	Fee	Australia	APAC	2	Fee (€)	12,875
49	Standard documentation to be submitted	Australia	APAC	3a	Cover letter	N/A
49	Standard documentation to be submitted	Australia	APAC	3b	Authorisation/application form	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3c	Investigator's Brochure	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3d	Clinical Investigation Plan (CIP)	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3e	Copy of the opinion of the ethics committee	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3f	Case Report Form (CRF)	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3g	Informed Consent Form (ICF)	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3h	Proof of insurance cover	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
49	Standard documentation to be submitted	Australia	APAC	3j	Proof of payment of the fee	Yes, optional
49	Standard documentation to be submitted	Australia	APAC	3k	Opinion of experts’ panels	No
49	Standard documentation to be submitted	Australia	APAC	3l	CE certificates of Notified Bodies	No
49	Standard documentation to be submitted	Australia	APAC	3m	Decisions of other Competent Authorities concerned	No
49	Standard documentation to be submitted	Australia	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	No
49	Standard documentation to be submitted	Australia	APAC	3o	Recruitment procedures and advertising materials	No
49	Standard documentation to be submitted	Australia	APAC	3p	Opinion of other Ethics Committees concerned	No
49	Standard documentation to be submitted	Australia	APAC	3q	General Device Information	Yes, mandatory
49	Standard documentation to be submitted	Australia	APAC	3r	Medicinal products contained in the device	Yes, mandatory
49	Standard documentation to be submitted	Australia	APAC	3s	List of participating countries	Yes, mandatory
49	Standard documentation to be submitted	Australia	APAC	3t	Trial centres list	Yes, mandatory
49	Standard documentation to be submitted	Australia	APAC	3u	Declaration of possession of requirements for trial centres	No
49	Standard documentation to be submitted	Australia	APAC	3v	Compliance to ISO 14155	Yes, mandatory
49	Standard documentation to be submitted	Australia	APAC	3w	MRI checklist	No
49	Standard documentation to be submitted	Australia	APAC	3x	Ionising radiation information	No
49	Standard documentation to be submitted	Australia	APAC	3y	Serious Adverse Event (SAE) Report Form	No
49	Patients' involvement	Australia	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
49	Patients' involvement	Australia	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
49	Patients' involvement	Australia	APAC	4b	Timing of patients’ involvement	N/A
49	HTA involvement	Australia	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
49	HTA involvement	Australia	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
49	HTA involvement	Australia	APAC	5b	Timing of HTA bodies’ involvement	N/A
49	Expert involvement	Australia	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
49	Expert involvement	Australia	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
49	Expert involvement	Australia	APAC	6b	Timing of expert panels’ involvement	N/A
49	Reimbursement	Australia	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
49	Reimbursement	Australia	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
50	Fee	China	APAC	1	Fee (€)	N/A
50	Standard documentation to be submitted	China	APAC	3	Standard documentation to be submitted:	N/A
50	Standard documentation to be submitted	China	APAC	3a	Cover letter	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3b	Authorisation/application form	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3c	Investigator's Brochure	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3e	Copy of the opinion of the ethics committee	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3f	Case Report Form (CRF)	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3h	Proof of insurance cover	N/A
50	Standard documentation to be submitted	China	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
50	Standard documentation to be submitted	China	APAC	3j	Proof of payment of the fee	N/A
50	Standard documentation to be submitted	China	APAC	3k	Opinion of experts’ panels	N/A
50	Standard documentation to be submitted	China	APAC	3l	CE certificates of Notified Bodies	N/A
50	Standard documentation to be submitted	China	APAC	3m	Decisions of other Competent Authorities concerned	N/A
50	Standard documentation to be submitted	China	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
50	Standard documentation to be submitted	China	APAC	3o	Recruitment procedures and advertising materials	N/A
50	Standard documentation to be submitted	China	APAC	3p	Opinion of other Ethics Committees concerned	N/A
50	Standard documentation to be submitted	China	APAC	3q	General Device Information	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3r	Medicinal products contained in the device	N/A
50	Standard documentation to be submitted	China	APAC	3s	List of participating countries	N/A
50	Standard documentation to be submitted	China	APAC	3t	Trial centres list	N/A
50	Standard documentation to be submitted	China	APAC	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	3v	Compliance to ISO 14155	N/A
50	Standard documentation to be submitted	China	APAC	3w	MRI checklist	N/A
50	Standard documentation to be submitted	China	APAC	3x	Ionising radiation information	N/A
50	Standard documentation to be submitted	China	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
50	Standard documentation to be submitted	China	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?
50	Patients' involvement	China	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
50	Patients' involvement	China	APAC	4b	Timing of patients’ involvement	N/A
50	HTA involvement	China	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
50	HTA involvement	China	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
50	HTA involvement	China	APAC	5b	Timing of HTA bodies’ involvement	N/A
50	Expert involvement	China	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
50	Expert involvement	China	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
50	Expert involvement	China	APAC	6b	Timing of expert panels’ involvement	N/A
50	Reimbursement	China	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
50	Reimbursement	China	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
51	Fee	Japan	APAC	1	Fee (€)	No fee
51	Standard documentation to be submitted	Japan	APAC	3	Standard documentation to be submitted:	N/A
51	Standard documentation to be submitted	Japan	APAC	3a	Cover letter	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3b	Authorisation/application form	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3c	Investigator's Brochure	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3e	Copy of the opinion of the ethics committee	No
51	Standard documentation to be submitted	Japan	APAC	3f	Case Report Form (CRF)	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3h	Proof of insurance cover	Yes, optional
51	Standard documentation to be submitted	Japan	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
51	Standard documentation to be submitted	Japan	APAC	3j	Proof of payment of the fee	N/A
51	Standard documentation to be submitted	Japan	APAC	3k	Opinion of experts’ panels	N/A
51	Standard documentation to be submitted	Japan	APAC	3l	CE certificates of Notified Bodies	N/A
51	Standard documentation to be submitted	Japan	APAC	3m	Decisions of other Competent Authorities concerned	No
51	Standard documentation to be submitted	Japan	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	No
51	Standard documentation to be submitted	Japan	APAC	3o	Recruitment procedures and advertising materials	No
51	Standard documentation to be submitted	Japan	APAC	3p	Opinion of other Ethics Committees concerned	No
51	Standard documentation to be submitted	Japan	APAC	3q	General Device Information	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3r	Medicinal products contained in the device	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3s	List of participating countries	Yes, optional
51	Standard documentation to be submitted	Japan	APAC	3t	Trial centres list	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
51	Standard documentation to be submitted	Japan	APAC	3v	Compliance to ISO 14155	Yes, optional
51	Standard documentation to be submitted	Japan	APAC	3w	MRI checklist	Yes, optional
51	Standard documentation to be submitted	Japan	APAC	3x	Ionising radiation information	No
51	Standard documentation to be submitted	Japan	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
51	Patients' involvement	Japan	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
51	Patients' involvement	Japan	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
51	Patients' involvement	Japan	APAC	4b	Timing of patients’ involvement	N/A
51	HTA involvement	Japan	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
51	HTA involvement	Japan	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
51	HTA involvement	Japan	APAC	5b	Timing of HTA bodies’ involvement	N/A
51	Expert involvement	Japan	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
51	Expert involvement	Japan	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
51	Expert involvement	Japan	APAC	6b	Timing of expert panels’ involvement	N/A
51	Reimbursement	Japan	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
51	Reimbursement	Japan	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
52	Fee	India	APAC	1	Fee (€)	Feasibility study 275 Pivotal study 1100
52	Standard documentation to be submitted	India	APAC	3	Standard documentation to be submitted:	N/A
52	Standard documentation to be submitted	India	APAC	3a	Cover letter	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3b	Authorisation/application form	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3c	Investigator's Brochure	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3e	Copy of the opinion of the ethics committee	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3f	Case Report Form (CRF)	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3h	Proof of insurance cover	No
52	Standard documentation to be submitted	India	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3j	Proof of payment of the fee	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3k	Opinion of experts’ panels	N/A
52	Standard documentation to be submitted	India	APAC	3l	CE certificates of Notified Bodies	N/A
52	Standard documentation to be submitted	India	APAC	3m	Decisions of other Competent Authorities concerned	N/A
52	Standard documentation to be submitted	India	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
52	Standard documentation to be submitted	India	APAC	3o	Recruitment procedures and advertising materials	N/A
52	Standard documentation to be submitted	India	APAC	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3q	General Device Information	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3r	Medicinal products contained in the device	Yes, optional
52	Standard documentation to be submitted	India	APAC	3s	List of participating countries	No
52	Standard documentation to be submitted	India	APAC	3t	Trial centres list	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3v	Compliance to ISO 14155	Yes, mandatory
52	Standard documentation to be submitted	India	APAC	3w	MRI checklist	N/A
52	Standard documentation to be submitted	India	APAC	3x	Ionising radiation information	N/A
52	Standard documentation to be submitted	India	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
52	Patients' involvement	India	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
52	Patients' involvement	India	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
52	Patients' involvement	India	APAC	4b	Timing of patients’ involvement	N/A
52	HTA involvement	India	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
52	HTA involvement	India	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
52	HTA involvement	India	APAC	5b	Timing of HTA bodies’ involvement	N/A
52	Expert involvement	India	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
52	Expert involvement	India	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
52	Expert involvement	India	APAC	6b	Timing of expert panels’ involvement	N/A
52	Reimbursement	India	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
52	Reimbursement	India	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
53	Fee	New_Zealand	APAC	1	Fee (€)	No fee
53	Standard documentation to be submitted	New_Zealand	APAC	3	Standard documentation to be submitted:	email to Medsafe with a brief summary of the your trial but no other attachments. The summary email should include: Medical devices involved, purpose of trial, who is involved, where it's taken place and any relevant information that is you think is useful to inform Medsafe about.
53	Standard documentation to be submitted	New_Zealand	APAC	3a	Cover letter	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3b	Authorisation/application form	Yes, mandatory
53	Standard documentation to be submitted	New_Zealand	APAC	3c	Investigator's Brochure	Yes, mandatory
53	Standard documentation to be submitted	New_Zealand	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
53	Standard documentation to be submitted	New_Zealand	APAC	3e	Copy of the opinion of the ethics committee	Yes, mandatory
53	Standard documentation to be submitted	New_Zealand	APAC	3f	Case Report Form (CRF)	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
53	Standard documentation to be submitted	New_Zealand	APAC	3h	Proof of insurance cover	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3j	Proof of payment of the fee	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3k	Opinion of experts’ panels	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3l	CE certificates of Notified Bodies	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3m	Decisions of other Competent Authorities concerned	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3o	Recruitment procedures and advertising materials	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3p	Opinion of other Ethics Committees concerned	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3q	General Device Information	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3r	Medicinal products contained in the device	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3s	List of participating countries	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3t	Trial centres list	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3u	Declaration of possession of requirements for trial centres	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3v	Compliance to ISO 14155	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3w	MRI checklist	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3x	Ionising radiation information	N/A
53	Standard documentation to be submitted	New_Zealand	APAC	3y	Serious Adverse Event (SAE) Report Form	N/A
53	Patients' involvement	New_Zealand	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
53	Patients' involvement	New_Zealand	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
53	Patients' involvement	New_Zealand	APAC	4b	Timing of patients’ involvement	N/A
53	HTA involvement	New_Zealand	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
53	HTA involvement	New_Zealand	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
53	HTA involvement	New_Zealand	APAC	5b	Timing of HTA bodies’ involvement	N/A
53	Expert involvement	New_Zealand	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
53	Expert involvement	New_Zealand	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
53	Expert involvement	New_Zealand	APAC	6b	Timing of expert panels’ involvement	N/A
53	Reimbursement	New_Zealand	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
53	Reimbursement	New_Zealand	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
54	Fee	Republic_of_Korea	APAC	1	Fee (€)	No fee
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3	Standard documentation to be submitted:	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3a	Cover letter	No
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3b	Authorisation/application form	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3c	Investigator's Brochure	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3e	Copy of the opinion of the ethics committee	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3f	Case Report Form (CRF)	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3h	Proof of insurance cover	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3j	Proof of payment of the fee	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3k	Opinion of experts’ panels	Yes, optional
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3l	CE certificates of Notified Bodies	No
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3m	Decisions of other Competent Authorities concerned	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3o	Recruitment procedures and advertising materials	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3q	General Device Information	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3r	Medicinal products contained in the device	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3s	List of participating countries	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3t	Trial centres list	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3u	Declaration of possession of requirements for trial centres	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3v	Compliance to ISO 14155	Yes, mandatory
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3w	MRI checklist	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3x	Ionising radiation information	N/A
54	Standard documentation to be submitted	Republic_of_Korea	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
54	Patients' involvement	Republic_of_Korea	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
54	Patients' involvement	Republic_of_Korea	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
54	Patients' involvement	Republic_of_Korea	APAC	4b	Timing of patients’ involvement	N/A
54	HTA involvement	Republic_of_Korea	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
54	HTA involvement	Republic_of_Korea	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
54	HTA involvement	Republic_of_Korea	APAC	5b	Timing of HTA bodies’ involvement	N/A
54	Expert involvement	Republic_of_Korea	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
54	Expert involvement	Republic_of_Korea	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
54	Expert involvement	Republic_of_Korea	APAC	6b	Timing of expert panels’ involvement	N/A
54	Reimbursement	Republic_of_Korea	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
54	Reimbursement	Republic_of_Korea	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
55	Fee	Taiwan	APAC	1	Fee (€)	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3	Standard documentation to be submitted:	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3a	Cover letter	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3b	Authorisation/application form	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3c	Investigator's Brochure	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3e	Copy of the opinion of the ethics committee	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3f	Case Report Form (CRF)	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3g	Informed Consent Form (ICF)	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3h	Proof of insurance cover	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
55	Standard documentation to be submitted	Taiwan	APAC	3j	Proof of payment of the fee	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3k	Opinion of experts’ panels	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3l	CE certificates of Notified Bodies	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3m	Decisions of other Competent Authorities concerned	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3o	Recruitment procedures and advertising materials	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3p	Opinion of other Ethics Committees concerned	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3q	General Device Information	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3r	Medicinal products contained in the device	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3s	List of participating countries	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3t	Trial centres list	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3u	Declaration of possession of requirements for trial centres	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3v	Compliance to ISO 14155	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3w	MRI checklist	N/A
55	Standard documentation to be submitted	Taiwan	APAC	3x	Ionising radiation information	Yes, optional
55	Standard documentation to be submitted	Taiwan	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
55	Patients' involvement	Taiwan	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
55	Patients' involvement	Taiwan	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
55	Patients' involvement	Taiwan	APAC	4b	Timing of patients’ involvement	N/A
55	HTA involvement	Taiwan	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
55	HTA involvement	Taiwan	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
55	HTA involvement	Taiwan	APAC	5b	Timing of HTA bodies’ involvement	N/A
55	Expert involvement	Taiwan	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
55	Expert involvement	Taiwan	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
55	Expert involvement	Taiwan	APAC	6b	Timing of expert panels’ involvement	N/A
55	Reimbursement	Taiwan	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
55	Reimbursement	Taiwan	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
56	Fee	Singapore	APAC	1	Fee (€)	N/A
56	Standard documentation to be submitted	Singapore	APAC	3	Standard documentation to be submitted:	N/A
56	Standard documentation to be submitted	Singapore	APAC	3a	Cover letter	Yes, mandatory
56	Standard documentation to be submitted	Singapore	APAC	3b	Authorisation/application form	Yes, mandatory
56	Standard documentation to be submitted	Singapore	APAC	3c	Investigator's Brochure	Yes, mandatory
56	Standard documentation to be submitted	Singapore	APAC	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
56	Standard documentation to be submitted	Singapore	APAC	3e	Copy of the opinion of the ethics committee	N/A
56	Standard documentation to be submitted	Singapore	APAC	3f	Case Report Form (CRF)	N/A
56	Standard documentation to be submitted	Singapore	APAC	3g	Informed Consent Form (ICF)	N/A
56	Standard documentation to be submitted	Singapore	APAC	3h	Proof of insurance cover	N/A
56	Standard documentation to be submitted	Singapore	APAC	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
56	Standard documentation to be submitted	Singapore	APAC	3j	Proof of payment of the fee	N/A
56	Standard documentation to be submitted	Singapore	APAC	3k	Opinion of experts’ panels	N/A
56	Standard documentation to be submitted	Singapore	APAC	3l	CE certificates of Notified Bodies	N/A
56	Standard documentation to be submitted	Singapore	APAC	3m	Decisions of other Competent Authorities concerned	N/A
56	Standard documentation to be submitted	Singapore	APAC	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
56	Standard documentation to be submitted	Singapore	APAC	3o	Recruitment procedures and advertising materials	N/A
56	Standard documentation to be submitted	Singapore	APAC	3p	Opinion of other Ethics Committees concerned	N/A
56	Standard documentation to be submitted	Singapore	APAC	3q	General Device Information	N/A
56	Standard documentation to be submitted	Singapore	APAC	3r	Medicinal products contained in the device	N/A
56	Standard documentation to be submitted	Singapore	APAC	3s	List of participating countries	N/A
56	Standard documentation to be submitted	Singapore	APAC	3t	Trial centres list	N/A
56	Standard documentation to be submitted	Singapore	APAC	3u	Declaration of possession of requirements for trial centres	N/A
56	Standard documentation to be submitted	Singapore	APAC	3v	Compliance to ISO 14155	N/A
56	Standard documentation to be submitted	Singapore	APAC	3w	MRI checklist	N/A
56	Standard documentation to be submitted	Singapore	APAC	3x	Ionising radiation information	N/A
56	Standard documentation to be submitted	Singapore	APAC	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
56	Patients' involvement	Singapore	APAC	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
56	Patients' involvement	Singapore	APAC	4a	Brief description of the type and extent of patients’ involvement	N/A
56	Patients' involvement	Singapore	APAC	4b	Timing of patients’ involvement	N/A
56	HTA involvement	Singapore	APAC	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
56	HTA involvement	Singapore	APAC	5a	Brief description of the type and extent of HTA bodies involvement	N/A
56	HTA involvement	Singapore	APAC	5b	Timing of HTA bodies’ involvement	N/A
56	Expert involvement	Singapore	APAC	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
56	Expert involvement	Singapore	APAC	6a	Brief description of the type and extent of expert panels’ involvement	N/A
56	Expert involvement	Singapore	APAC	6b	Timing of expert panels’ involvement	N/A
56	Reimbursement	Singapore	APAC	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
56	Reimbursement	Singapore	APAC	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
ID	Group	Country	Jurisdiction	Code vars	Variables	Procedure

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