Procedural Section

Country :

Jurisdiction :

Topic :

Country	Category	Jurisdiction	ID	Code vars	Topic	Procedure
Austria	General	EU	1	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
Austria	Fee	EU	1	2	Fee (€)	7927
Austria	Standard documentation to be submitted	EU	1	3a	Cover letter	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3b	Authorisation/application form	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3c	Investigator's Brochure	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3f	Case Report Form (CRF)	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3g	Informed Consent Form (ICF)	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3h	Proof of insurance cover	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Austria	Standard documentation to be submitted	EU	1	3j	Proof of payment of the fee	No
Austria	Standard documentation to be submitted	EU	1	3k	Opinion of experts’ panels	No
Austria	Standard documentation to be submitted	EU	1	3l	CE certificates of Notified Bodies	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3m	Decisions of other Competent Authorities concerned	No
Austria	Standard documentation to be submitted	EU	1	3n	Post Market Clinical Follow-up (PMCF) plan	No
Austria	Standard documentation to be submitted	EU	1	3o	Recruitment procedures and advertising materials	No
Austria	Standard documentation to be submitted	EU	1	3p	Opinion of other Ethics Committees concerned	No
Austria	Standard documentation to be submitted	EU	1	3q	General Device Information	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3r	Medicinal products contained in the device	N/A
Austria	Standard documentation to be submitted	EU	1	3s	List of participating countries	N/A
Austria	Standard documentation to be submitted	EU	1	3t	Trial centres list	N/A
Austria	Standard documentation to be submitted	EU	1	3u	Declaration of possession of requirements for trial centres	No
Austria	Standard documentation to be submitted	EU	1	3v	Compliance to ISO 14155	Yes, mandatory
Austria	Standard documentation to be submitted	EU	1	3w	MRI checklist	N/A
Austria	Standard documentation to be submitted	EU	1	3x	Ionising radiation information	N/A
Austria	Standard documentation to be submitted	EU	1	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Austria	Patients' involvement	EU	1	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Austria	Patients' involvement	EU	1	4a	Brief description of the type and extent of patients’ involvement	N/A
Austria	Patients' involvement	EU	1	4b	Timing of patients’ involvement	N/A
Austria	HTA involvement	EU	1	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Austria	HTA involvement	EU	1	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Austria	HTA involvement	EU	1	5b	Timing of HTA bodies’ involvement	N/A
Austria	Expert involvement	EU	1	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Austria	Expert involvement	EU	1	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Austria	Expert involvement	EU	1	6b	Timing of expert panels’ involvement	N/A
Austria	Reimbursement	EU	1	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Austria	Reimbursement	EU	1	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Belgium	General	EU	2	1	Link to the website of the procedure	https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/clinical_evaluation/DM
Belgium	Fee	EU	2	2	Fee (€)	I/II 12466 III 18013 If dossiers are withdrawn or rejected 592
Belgium	Standard documentation to be submitted	EU	2	3a	Cover letter	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3b	Authorisation/application form	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3c	Investigator's Brochure	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3e	Copy of the opinion of the ethics committee	N/A
Belgium	Standard documentation to be submitted	EU	2	3f	Case Report Form (CRF)	N/A
Belgium	Standard documentation to be submitted	EU	2	3g	Informed Consent Form (ICF)	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3h	Proof of insurance cover	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3j	Proof of payment of the fee	N/A
Belgium	Standard documentation to be submitted	EU	2	3k	Opinion of experts’ panels	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3l	CE certificates of Notified Bodies	N/A
Belgium	Standard documentation to be submitted	EU	2	3m	Decisions of other Competent Authorities concerned	N/A
Belgium	Standard documentation to be submitted	EU	2	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Belgium	Standard documentation to be submitted	EU	2	3o	Recruitment procedures and advertising materials	N/A
Belgium	Standard documentation to be submitted	EU	2	3p	Opinion of other Ethics Committees concerned	N/A
Belgium	Standard documentation to be submitted	EU	2	3q	General Device Information	N/A
Belgium	Standard documentation to be submitted	EU	2	3r	Medicinal products contained in the device	N/A
Belgium	Standard documentation to be submitted	EU	2	3s	List of participating countries	N/A
Belgium	Standard documentation to be submitted	EU	2	3t	Trial centres list	Yes, mandatory
Belgium	Standard documentation to be submitted	EU	2	3u	Declaration of possession of requirements for trial centres	N/A
Belgium	Standard documentation to be submitted	EU	2	3v	Compliance to ISO 14155	N/A
Belgium	Standard documentation to be submitted	EU	2	3w	MRI checklist	N/A
Belgium	Standard documentation to be submitted	EU	2	3x	Ionising radiation information	N/A
Belgium	Standard documentation to be submitted	EU	2	3y	Serious Adverse Event (SAE) Report Form	N/A
Belgium	Patients' involvement	EU	2	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	Yes, mandatory
Belgium	Patients' involvement	EU	2	4a	Brief description of the type and extent of patients’ involvement	N/A
Belgium	Patients' involvement	EU	2	4b	Timing of patients’ involvement	N/A
Belgium	HTA involvement	EU	2	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	Yes, optional
Belgium	HTA involvement	EU	2	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
Belgium	HTA involvement	EU	2	5b	Timing of HTA bodies’ involvement	N/A
Belgium	Expert involvement	EU	2	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Belgium	Expert involvement	EU	2	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Belgium	Expert involvement	EU	2	6b	Timing of expert panels’ involvement	N/A
Belgium	Reimbursement	EU	2	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	Yes, mandatory
Belgium	Reimbursement	EU	2	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Bulgaria	General	EU	3	1	Link to the website of the procedure	https://iisda.government.bg/adm_services/services/service_provision/6825
Bulgaria	Fee	EU	3	2	Fee (€)	1532
Bulgaria	Standard documentation to be submitted	EU	3	3a	Cover letter	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3b	Authorisation/application form	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3c	Investigator's Brochure	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3f	Case Report Form (CRF)	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3g	Informed Consent Form (ICF)	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3h	Proof of insurance cover	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3j	Proof of payment of the fee	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3k	Opinion of experts’ panels	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3l	CE certificates of Notified Bodies	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3m	Decisions of other Competent Authorities concerned	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3o	Recruitment procedures and advertising materials	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3p	Opinion of other Ethics Committees concerned	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3q	General Device Information	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3r	Medicinal products contained in the device	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3s	List of participating countries	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3t	Trial centres list	Yes, mandatory
Bulgaria	Standard documentation to be submitted	EU	3	3u	Declaration of possession of requirements for trial centres	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3v	Compliance to ISO 14155	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3w	MRI checklist	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3x	Ionising radiation information	N/A
Bulgaria	Standard documentation to be submitted	EU	3	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Bulgaria	Patients' involvement	EU	3	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Bulgaria	Patients' involvement	EU	3	4a	Brief description of the type and extent of patients’ involvement	N/A
Bulgaria	Patients' involvement	EU	3	4b	Timing of patients’ involvement	N/A
Bulgaria	HTA involvement	EU	3	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Bulgaria	HTA involvement	EU	3	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Bulgaria	HTA involvement	EU	3	5b	Timing of HTA bodies’ involvement	N/A
Bulgaria	Expert involvement	EU	3	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Bulgaria	Expert involvement	EU	3	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Bulgaria	Expert involvement	EU	3	6b	Timing of expert panels’ involvement	N/A
Bulgaria	Reimbursement	EU	3	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Bulgaria	Reimbursement	EU	3	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Croatia	General	EU	4	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/
Croatia	Fee	EU	4	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
Croatia	Standard documentation to be submitted	EU	4	3a	Cover letter	N/A
Croatia	Standard documentation to be submitted	EU	4	3b	Authorisation/application form	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3c	Investigator's Brochure	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3e	Copy of the opinion of the ethics committee	N/A
Croatia	Standard documentation to be submitted	EU	4	3f	Case Report Form (CRF)	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3g	Informed Consent Form (ICF)	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3h	Proof of insurance cover	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Croatia	Standard documentation to be submitted	EU	4	3j	Proof of payment of the fee	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3k	Opinion of experts’ panels	N/A
Croatia	Standard documentation to be submitted	EU	4	3l	CE certificates of Notified Bodies	N/A
Croatia	Standard documentation to be submitted	EU	4	3m	Decisions of other Competent Authorities concerned	N/A
Croatia	Standard documentation to be submitted	EU	4	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Croatia	Standard documentation to be submitted	EU	4	3o	Recruitment procedures and advertising materials	N/A
Croatia	Standard documentation to be submitted	EU	4	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3q	General Device Information	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3r	Medicinal products contained in the device	N/A
Croatia	Standard documentation to be submitted	EU	4	3s	List of participating countries	N/A
Croatia	Standard documentation to be submitted	EU	4	3t	Trial centres list	Yes, mandatory
Croatia	Standard documentation to be submitted	EU	4	3u	Declaration of possession of requirements for trial centres	N/A
Croatia	Standard documentation to be submitted	EU	4	3v	Compliance to ISO 14155	N/A
Croatia	Standard documentation to be submitted	EU	4	3w	MRI checklist	N/A
Croatia	Standard documentation to be submitted	EU	4	3x	Ionising radiation information	N/A
Croatia	Standard documentation to be submitted	EU	4	3y	Serious Adverse Event (SAE) Report Form	N/A
Croatia	Patients' involvement	EU	4	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Croatia	Patients' involvement	EU	4	4a	Brief description of the type and extent of patients’ involvement	N/A
Croatia	Patients' involvement	EU	4	4b	Timing of patients’ involvement	N/A
Croatia	HTA involvement	EU	4	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Croatia	HTA involvement	EU	4	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Croatia	HTA involvement	EU	4	5b	Timing of HTA bodies’ involvement	N/A
Croatia	Expert involvement	EU	4	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Croatia	Expert involvement	EU	4	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Croatia	Expert involvement	EU	4	6b	Timing of expert panels’ involvement	N/A
Croatia	Reimbursement	EU	4	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Croatia	Reimbursement	EU	4	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Cyprus	General	EU	5	1	Link to the website of the procedure	https://www.moh.gov.cy/moh/mphs/mphs.nsf/page23_en/page23_en?OpenDocument
Cyprus	Fee	EU	5	2	Fee (€)	N/A
Cyprus	Standard documentation to be submitted	EU	5	3a	Cover letter	N/A
Cyprus	Standard documentation to be submitted	EU	5	3b	Authorisation/application form	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3c	Investigator's Brochure	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3f	Case Report Form (CRF)	N/A
Cyprus	Standard documentation to be submitted	EU	5	3g	Informed Consent Form (ICF)	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3h	Proof of insurance cover	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Cyprus	Standard documentation to be submitted	EU	5	3j	Proof of payment of the fee	N/A
Cyprus	Standard documentation to be submitted	EU	5	3k	Opinion of experts’ panels	N/A
Cyprus	Standard documentation to be submitted	EU	5	3l	CE certificates of Notified Bodies	N/A
Cyprus	Standard documentation to be submitted	EU	5	3m	Decisions of other Competent Authorities concerned	N/A
Cyprus	Standard documentation to be submitted	EU	5	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Cyprus	Standard documentation to be submitted	EU	5	3o	Recruitment procedures and advertising materials	N/A
Cyprus	Standard documentation to be submitted	EU	5	3p	Opinion of other Ethics Committees concerned	N/A
Cyprus	Standard documentation to be submitted	EU	5	3q	General Device Information	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3r	Medicinal products contained in the device	N/A
Cyprus	Standard documentation to be submitted	EU	5	3s	List of participating countries	N/A
Cyprus	Standard documentation to be submitted	EU	5	3t	Trial centres list	Yes, mandatory
Cyprus	Standard documentation to be submitted	EU	5	3u	Declaration of possession of requirements for trial centres	N/A
Cyprus	Standard documentation to be submitted	EU	5	3v	Compliance to ISO 14155	N/A
Cyprus	Standard documentation to be submitted	EU	5	3w	MRI checklist	N/A
Cyprus	Standard documentation to be submitted	EU	5	3x	Ionising radiation information	N/A
Cyprus	Standard documentation to be submitted	EU	5	3y	Serious Adverse Event (SAE) Report Form	N/A
Cyprus	Patients' involvement	EU	5	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Cyprus	Patients' involvement	EU	5	4a	Brief description of the type and extent of patients’ involvement	N/A
Cyprus	Patients' involvement	EU	5	4b	Timing of patients’ involvement	N/A
Cyprus	HTA involvement	EU	5	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Cyprus	HTA involvement	EU	5	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Cyprus	HTA involvement	EU	5	5b	Timing of HTA bodies’ involvement	N/A
Cyprus	Expert involvement	EU	5	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Cyprus	Expert involvement	EU	5	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Cyprus	Expert involvement	EU	5	6b	Timing of expert panels’ involvement	N/A
Cyprus	Reimbursement	EU	5	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Cyprus	Reimbursement	EU	5	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Czechia	General	EU	6	1	Link to the website of the procedure	https://www.sukl.eu/medical-devices/podani-zadosti-o-povoleni-provedeni-klinicke-zkousky
Czechia	Fee	EU	6	2	Fee (€)	No fee
Czechia	Standard documentation to be submitted	EU	6	3a	Cover letter	N/A
Czechia	Standard documentation to be submitted	EU	6	3b	Authorisation/application form	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3c	Investigator's Brochure	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3f	Case Report Form (CRF)	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3g	Informed Consent Form (ICF)	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3h	Proof of insurance cover	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3j	Proof of payment of the fee	N/A
Czechia	Standard documentation to be submitted	EU	6	3k	Opinion of experts’ panels	N/A
Czechia	Standard documentation to be submitted	EU	6	3l	CE certificates of Notified Bodies	N/A
Czechia	Standard documentation to be submitted	EU	6	3m	Decisions of other Competent Authorities concerned	N/A
Czechia	Standard documentation to be submitted	EU	6	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Czechia	Standard documentation to be submitted	EU	6	3o	Recruitment procedures and advertising materials	N/A
Czechia	Standard documentation to be submitted	EU	6	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3q	General Device Information	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3r	Medicinal products contained in the device	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3s	List of participating countries	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3t	Trial centres list	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3u	Declaration of possession of requirements for trial centres	N/A
Czechia	Standard documentation to be submitted	EU	6	3v	Compliance to ISO 14155	Yes, optional
Czechia	Standard documentation to be submitted	EU	6	3w	MRI checklist	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3x	Ionising radiation information	Yes, mandatory
Czechia	Standard documentation to be submitted	EU	6	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Czechia	Patients' involvement	EU	6	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Czechia	Patients' involvement	EU	6	4a	Brief description of the type and extent of patients’ involvement	N/A
Czechia	Patients' involvement	EU	6	4b	Timing of patients’ involvement	N/A
Czechia	HTA involvement	EU	6	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Czechia	HTA involvement	EU	6	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Czechia	HTA involvement	EU	6	5b	Timing of HTA bodies’ involvement	N/A
Czechia	Expert involvement	EU	6	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Czechia	Expert involvement	EU	6	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Czechia	Expert involvement	EU	6	6b	Timing of expert panels’ involvement	N/A
Czechia	Reimbursement	EU	6	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Czechia	Reimbursement	EU	6	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Denmark	General	EU	7	1	Link to the website of the procedure	https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
Denmark	Fee	EU	7	2	Fee (€)	I/IIa/IIb 936 IIb invasive/III 1258
Denmark	Standard documentation to be submitted	EU	7	3a	Cover letter	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3b	Authorisation/application form	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3c	Investigator's Brochure	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3f	Case Report Form (CRF)	N/A
Denmark	Standard documentation to be submitted	EU	7	3g	Informed Consent Form (ICF)	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3h	Proof of insurance cover	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3j	Proof of payment of the fee	N/A
Denmark	Standard documentation to be submitted	EU	7	3k	Opinion of experts’ panels	N/A
Denmark	Standard documentation to be submitted	EU	7	3l	CE certificates of Notified Bodies	N/A
Denmark	Standard documentation to be submitted	EU	7	3m	Decisions of other Competent Authorities concerned	N/A
Denmark	Standard documentation to be submitted	EU	7	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Denmark	Standard documentation to be submitted	EU	7	3o	Recruitment procedures and advertising materials	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3p	Opinion of other Ethics Committees concerned	N/A
Denmark	Standard documentation to be submitted	EU	7	3q	General Device Information	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3r	Medicinal products contained in the device	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3s	List of participating countries	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3t	Trial centres list	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3u	Declaration of possession of requirements for trial centres	N/A
Denmark	Standard documentation to be submitted	EU	7	3v	Compliance to ISO 14155	Yes, mandatory
Denmark	Standard documentation to be submitted	EU	7	3w	MRI checklist	N/A
Denmark	Standard documentation to be submitted	EU	7	3x	Ionising radiation information	N/A
Denmark	Standard documentation to be submitted	EU	7	3y	Serious Adverse Event (SAE) Report Form	N/A
Denmark	Patients' involvement	EU	7	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Denmark	Patients' involvement	EU	7	4a	Brief description of the type and extent of patients’ involvement	N/A
Denmark	Patients' involvement	EU	7	4b	Timing of patients’ involvement	N/A
Denmark	HTA involvement	EU	7	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Denmark	HTA involvement	EU	7	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Denmark	HTA involvement	EU	7	5b	Timing of HTA bodies’ involvement	N/A
Denmark	Expert involvement	EU	7	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Denmark	Expert involvement	EU	7	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Denmark	Expert involvement	EU	7	6b	Timing of expert panels’ involvement	N/A
Denmark	Reimbursement	EU	7	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Denmark	Reimbursement	EU	7	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Estonia	General	EU	8	1	Link to the website of the procedure	N/A
Estonia	Fee	EU	8	2	Fee (€)	210 state fee + 405 or 1457 (Health Board fee depending on the type of study requested)
Estonia	Standard documentation to be submitted	EU	8	3a	Cover letter	Yes, optional
Estonia	Standard documentation to be submitted	EU	8	3b	Authorisation/application form	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3c	Investigator's Brochure	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3f	Case Report Form (CRF)	No
Estonia	Standard documentation to be submitted	EU	8	3g	Informed Consent Form (ICF)	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3h	Proof of insurance cover	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3j	Proof of payment of the fee	No
Estonia	Standard documentation to be submitted	EU	8	3k	Opinion of experts’ panels	No
Estonia	Standard documentation to be submitted	EU	8	3l	CE certificates of Notified Bodies	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3m	Decisions of other Competent Authorities concerned	No
Estonia	Standard documentation to be submitted	EU	8	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3o	Recruitment procedures and advertising materials	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3p	Opinion of other Ethics Committees concerned	Yes, optional
Estonia	Standard documentation to be submitted	EU	8	3q	General Device Information	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3r	Medicinal products contained in the device	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3s	List of participating countries	No
Estonia	Standard documentation to be submitted	EU	8	3t	Trial centres list	Yes, mandatory
Estonia	Standard documentation to be submitted	EU	8	3u	Declaration of possession of requirements for trial centres	No
Estonia	Standard documentation to be submitted	EU	8	3v	Compliance to ISO 14155	No
Estonia	Standard documentation to be submitted	EU	8	3w	MRI checklist	No
Estonia	Standard documentation to be submitted	EU	8	3x	Ionising radiation information	No
Estonia	Standard documentation to be submitted	EU	8	3y	Serious Adverse Event (SAE) Report Form	No
Estonia	Patients' involvement	EU	8	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Estonia	Patients' involvement	EU	8	4a	Brief description of the type and extent of patients’ involvement	No
Estonia	Patients' involvement	EU	8	4b	Timing of patients’ involvement	No
Estonia	HTA involvement	EU	8	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Estonia	HTA involvement	EU	8	5a	Brief description of the type and extent of HTA bodies involvement	No
Estonia	HTA involvement	EU	8	5b	Timing of HTA bodies’ involvement	No
Estonia	Expert involvement	EU	8	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Estonia	Expert involvement	EU	8	6a	Brief description of the type and extent of expert panels’ involvement	No
Estonia	Expert involvement	EU	8	6b	Timing of expert panels’ involvement	No
Estonia	Reimbursement	EU	8	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Estonia	Reimbursement	EU	8	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
Finland	General	EU	9	1	Link to the website of the procedure	https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
Finland	Fee	EU	9	2	Fee (€)	I 770 IIa to III 1930
Finland	Standard documentation to be submitted	EU	9	3a	Cover letter	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3b	Authorisation/application form	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3c	Investigator's Brochure	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3f	Case Report Form (CRF)	N/A
Finland	Standard documentation to be submitted	EU	9	3g	Informed Consent Form (ICF)	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3h	Proof of insurance cover	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3j	Proof of payment of the fee	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3k	Opinion of experts’ panels	Yes, optional
Finland	Standard documentation to be submitted	EU	9	3l	CE certificates of Notified Bodies	Yes, optional
Finland	Standard documentation to be submitted	EU	9	3m	Decisions of other Competent Authorities concerned	Yes, optional
Finland	Standard documentation to be submitted	EU	9	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Finland	Standard documentation to be submitted	EU	9	3o	Recruitment procedures and advertising materials	Yes, optional
Finland	Standard documentation to be submitted	EU	9	3p	Opinion of other Ethics Committees concerned	N/A
Finland	Standard documentation to be submitted	EU	9	3q	General Device Information	N/A
Finland	Standard documentation to be submitted	EU	9	3r	Medicinal products contained in the device	N/A
Finland	Standard documentation to be submitted	EU	9	3s	List of participating countries	N/A
Finland	Standard documentation to be submitted	EU	9	3t	Trial centres list	Yes, mandatory
Finland	Standard documentation to be submitted	EU	9	3u	Declaration of possession of requirements for trial centres	N/A
Finland	Standard documentation to be submitted	EU	9	3v	Compliance to ISO 14155	N/A
Finland	Standard documentation to be submitted	EU	9	3w	MRI checklist	N/A
Finland	Standard documentation to be submitted	EU	9	3x	Ionising radiation information	N/A
Finland	Standard documentation to be submitted	EU	9	3y	Serious Adverse Event (SAE) Report Form	N/A
Finland	Patients' involvement	EU	9	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Finland	Patients' involvement	EU	9	4a	Brief description of the type and extent of patients’ involvement	N/A
Finland	Patients' involvement	EU	9	4b	Timing of patients’ involvement	N/A
Finland	HTA involvement	EU	9	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Finland	HTA involvement	EU	9	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Finland	HTA involvement	EU	9	5b	Timing of HTA bodies’ involvement	N/A
Finland	Expert involvement	EU	9	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Finland	Expert involvement	EU	9	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Finland	Expert involvement	EU	9	6b	Timing of expert panels’ involvement	N/A
Finland	Reimbursement	EU	9	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Finland	Reimbursement	EU	9	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
France	General	EU	10	1	Link to the website of the procedure	Dispositifs médicaux - Demander une autorisation pour une inves - ANSM (sante.fr)
France	Fee	EU	10	2	Fee (€)	N/A
France	Standard documentation to be submitted	EU	10	3a	Cover letter	N/A
France	Standard documentation to be submitted	EU	10	3b	Authorisation/application form	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3c	Investigator's Brochure	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3e	Copy of the opinion of the ethics committee	Yes, optional
France	Standard documentation to be submitted	EU	10	3f	Case Report Form (CRF)	N/A
France	Standard documentation to be submitted	EU	10	3g	Informed Consent Form (ICF)	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3h	Proof of insurance cover	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3j	Proof of payment of the fee	N/A
France	Standard documentation to be submitted	EU	10	3k	Opinion of experts’ panels	Yes, optional
France	Standard documentation to be submitted	EU	10	3l	CE certificates of Notified Bodies	No
France	Standard documentation to be submitted	EU	10	3m	Decisions of other Competent Authorities concerned	N/A
France	Standard documentation to be submitted	EU	10	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3o	Recruitment procedures and advertising materials	N/A
France	Standard documentation to be submitted	EU	10	3p	Opinion of other Ethics Committees concerned	N/A
France	Standard documentation to be submitted	EU	10	3q	General Device Information	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3r	Medicinal products contained in the device	Yes, mandatory
France	Standard documentation to be submitted	EU	10	3s	List of participating countries	N/A
France	Standard documentation to be submitted	EU	10	3t	Trial centres list	N/A
France	Standard documentation to be submitted	EU	10	3u	Declaration of possession of requirements for trial centres	N/A
France	Standard documentation to be submitted	EU	10	3v	Compliance to ISO 14155	N/A
France	Standard documentation to be submitted	EU	10	3w	MRI checklist	N/A
France	Standard documentation to be submitted	EU	10	3x	Ionising radiation information	Yes, optional
France	Standard documentation to be submitted	EU	10	3y	Serious Adverse Event (SAE) Report Form	N/A
France	Patients' involvement	EU	10	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
France	Patients' involvement	EU	10	4a	Brief description of the type and extent of patients’ involvement	N/A
France	Patients' involvement	EU	10	4b	Timing of patients’ involvement	N/A
France	HTA involvement	EU	10	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
France	HTA involvement	EU	10	5a	Brief description of the type and extent of HTA bodies involvement	N/A
France	HTA involvement	EU	10	5b	Timing of HTA bodies’ involvement	N/A
France	Expert involvement	EU	10	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
France	Expert involvement	EU	10	6a	Brief description of the type and extent of expert panels’ involvement	N/A
France	Expert involvement	EU	10	6b	Timing of expert panels’ involvement	N/A
France	Reimbursement	EU	10	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
France	Reimbursement	EU	10	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Germany	General	EU	11	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
Germany	Fee	EU	11	2	Fee (€)	The final fee is not determined until the end of a procedure.
Germany	Standard documentation to be submitted	EU	11	3a	Cover letter	No
Germany	Standard documentation to be submitted	EU	11	3b	Authorisation/application form	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3c	Investigator's Brochure	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3f	Case Report Form (CRF)	N/A
Germany	Standard documentation to be submitted	EU	11	3g	Informed Consent Form (ICF)	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3h	Proof of insurance cover	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3j	Proof of payment of the fee	N/A
Germany	Standard documentation to be submitted	EU	11	3k	Opinion of experts’ panels	N/A
Germany	Standard documentation to be submitted	EU	11	3l	CE certificates of Notified Bodies	N/A
Germany	Standard documentation to be submitted	EU	11	3m	Decisions of other Competent Authorities concerned	N/A
Germany	Standard documentation to be submitted	EU	11	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Germany	Standard documentation to be submitted	EU	11	3o	Recruitment procedures and advertising materials	N/A
Germany	Standard documentation to be submitted	EU	11	3p	Opinion of other Ethics Committees concerned	N/A
Germany	Standard documentation to be submitted	EU	11	3q	General Device Information	N/A
Germany	Standard documentation to be submitted	EU	11	3r	Medicinal products contained in the device	N/A
Germany	Standard documentation to be submitted	EU	11	3s	List of participating countries	N/A
Germany	Standard documentation to be submitted	EU	11	3t	Trial centres list	N/A
Germany	Standard documentation to be submitted	EU	11	3u	Declaration of possession of requirements for trial centres	N/A
Germany	Standard documentation to be submitted	EU	11	3v	Compliance to ISO 14155	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3w	MRI checklist	No
Germany	Standard documentation to be submitted	EU	11	3x	Ionising radiation information	Yes, mandatory
Germany	Standard documentation to be submitted	EU	11	3y	Serious Adverse Event (SAE) Report Form	N/A
Germany	Patients' involvement	EU	11	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Germany	Patients' involvement	EU	11	4a	Brief description of the type and extent of patients’ involvement	N/A
Germany	Patients' involvement	EU	11	4b	Timing of patients’ involvement	N/A
Germany	HTA involvement	EU	11	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Germany	HTA involvement	EU	11	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Germany	HTA involvement	EU	11	5b	Timing of HTA bodies’ involvement	N/A
Germany	Expert involvement	EU	11	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Germany	Expert involvement	EU	11	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Germany	Expert involvement	EU	11	6b	Timing of expert panels’ involvement	N/A
Germany	Reimbursement	EU	11	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Germany	Reimbursement	EU	11	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
Greece	General	EU	12	1	Link to the website of the procedure	https://www.eof.gr/web/guest/clinical-md
Greece	Fee	EU	12	2	Fee (€)	1000
Greece	Standard documentation to be submitted	EU	12	3a	Cover letter	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3b	Authorisation/application form	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3c	Investigator's Brochure	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3e	Copy of the opinion of the ethics committee	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3f	Case Report Form (CRF)	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3g	Informed Consent Form (ICF)	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3h	Proof of insurance cover	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3j	Proof of payment of the fee	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3k	Opinion of experts’ panels	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3l	CE certificates of Notified Bodies	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3m	Decisions of other Competent Authorities concerned	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3o	Recruitment procedures and advertising materials	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3p	Opinion of other Ethics Committees concerned	Yes, optional
Greece	Standard documentation to be submitted	EU	12	3q	General Device Information	N/A
Greece	Standard documentation to be submitted	EU	12	3r	Medicinal products contained in the device	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3s	List of participating countries	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3t	Trial centres list	Yes, mandatory
Greece	Standard documentation to be submitted	EU	12	3u	Declaration of possession of requirements for trial centres	N/A
Greece	Standard documentation to be submitted	EU	12	3v	Compliance to ISO 14155	N/A
Greece	Standard documentation to be submitted	EU	12	3w	MRI checklist	N/A
Greece	Standard documentation to be submitted	EU	12	3x	Ionising radiation information	N/A
Greece	Standard documentation to be submitted	EU	12	3y	Serious Adverse Event (SAE) Report Form	N/A
Greece	Patients' involvement	EU	12	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Greece	Patients' involvement	EU	12	4a	Brief description of the type and extent of patients’ involvement	N/A
Greece	Patients' involvement	EU	12	4b	Timing of patients’ involvement	N/A
Greece	HTA involvement	EU	12	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Greece	HTA involvement	EU	12	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Greece	HTA involvement	EU	12	5b	Timing of HTA bodies’ involvement	N/A
Greece	Expert involvement	EU	12	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Greece	Expert involvement	EU	12	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Greece	Expert involvement	EU	12	6b	Timing of expert panels’ involvement	N/A
Greece	Reimbursement	EU	12	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Greece	Reimbursement	EU	12	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Hungary	General	EU	13	1	Link to the website of the procedure	https://ogyei.gov.hu/klinikai_vizsgalatok_orvostechnika
Hungary	Fee	EU	13	2	Fee (€)	Non-radioactive 468 Radioactive 764
Hungary	Standard documentation to be submitted	EU	13	3a	Cover letter	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3b	Authorisation/application form	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3c	Investigator's Brochure	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3f	Case Report Form (CRF)	N/A
Hungary	Standard documentation to be submitted	EU	13	3g	Informed Consent Form (ICF)	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3h	Proof of insurance cover	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3j	Proof of payment of the fee	Yes, optional
Hungary	Standard documentation to be submitted	EU	13	3k	Opinion of experts’ panels	Yes, optional
Hungary	Standard documentation to be submitted	EU	13	3l	CE certificates of Notified Bodies	Yes, optional
Hungary	Standard documentation to be submitted	EU	13	3m	Decisions of other Competent Authorities concerned	N/A
Hungary	Standard documentation to be submitted	EU	13	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Hungary	Standard documentation to be submitted	EU	13	3o	Recruitment procedures and advertising materials	Yes, optional
Hungary	Standard documentation to be submitted	EU	13	3p	Opinion of other Ethics Committees concerned	N/A
Hungary	Standard documentation to be submitted	EU	13	3q	General Device Information	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3r	Medicinal products contained in the device	N/A
Hungary	Standard documentation to be submitted	EU	13	3s	List of participating countries	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3t	Trial centres list	N/A
Hungary	Standard documentation to be submitted	EU	13	3u	Declaration of possession of requirements for trial centres	N/A
Hungary	Standard documentation to be submitted	EU	13	3v	Compliance to ISO 14155	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3w	MRI checklist	N/A
Hungary	Standard documentation to be submitted	EU	13	3x	Ionising radiation information	Yes, mandatory
Hungary	Standard documentation to be submitted	EU	13	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
Hungary	Patients' involvement	EU	13	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Hungary	Patients' involvement	EU	13	4a	Brief description of the type and extent of patients’ involvement	N/A
Hungary	Patients' involvement	EU	13	4b	Timing of patients’ involvement	N/A
Hungary	HTA involvement	EU	13	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Hungary	HTA involvement	EU	13	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Hungary	HTA involvement	EU	13	5b	Timing of HTA bodies’ involvement	N/A
Hungary	Expert involvement	EU	13	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Hungary	Expert involvement	EU	13	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Hungary	Expert involvement	EU	13	6b	Timing of expert panels’ involvement	N/A
Hungary	Reimbursement	EU	13	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Hungary	Reimbursement	EU	13	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Ireland	General	EU	14	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
Ireland	Fee	EU	14	2	Fee (€)	I/IIa 1930 IIb/III 4365 Resubmission of a clinical investigation/performance study/accademic sponsor 520
Ireland	Standard documentation to be submitted	EU	14	3a	Cover letter	N/A
Ireland	Standard documentation to be submitted	EU	14	3b	Authorisation/application form	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3c	Investigator's Brochure	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3e	Copy of the opinion of the ethics committee	Yes, optional
Ireland	Standard documentation to be submitted	EU	14	3f	Case Report Form (CRF)	N/A
Ireland	Standard documentation to be submitted	EU	14	3g	Informed Consent Form (ICF)	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3h	Proof of insurance cover	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3j	Proof of payment of the fee	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3k	Opinion of experts’ panels	N/A
Ireland	Standard documentation to be submitted	EU	14	3l	CE certificates of Notified Bodies	N/A
Ireland	Standard documentation to be submitted	EU	14	3m	Decisions of other Competent Authorities concerned	N/A
Ireland	Standard documentation to be submitted	EU	14	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Ireland	Standard documentation to be submitted	EU	14	3o	Recruitment procedures and advertising materials	N/A
Ireland	Standard documentation to be submitted	EU	14	3p	Opinion of other Ethics Committees concerned	N/A
Ireland	Standard documentation to be submitted	EU	14	3q	General Device Information	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3r	Medicinal products contained in the device	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3s	List of participating countries	Yes, mandatory
Ireland	Standard documentation to be submitted	EU	14	3t	Trial centres list	N/A
Ireland	Standard documentation to be submitted	EU	14	3u	Declaration of possession of requirements for trial centres	N/A
Ireland	Standard documentation to be submitted	EU	14	3v	Compliance to ISO 14155	N/A
Ireland	Standard documentation to be submitted	EU	14	3w	MRI checklist	N/A
Ireland	Standard documentation to be submitted	EU	14	3x	Ionising radiation information	N/A
Ireland	Standard documentation to be submitted	EU	14	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Ireland	Patients' involvement	EU	14	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Ireland	Patients' involvement	EU	14	4a	Brief description of the type and extent of patients’ involvement	N/A
Ireland	Patients' involvement	EU	14	4b	Timing of patients’ involvement	N/A
Ireland	HTA involvement	EU	14	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Ireland	HTA involvement	EU	14	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Ireland	HTA involvement	EU	14	5b	Timing of HTA bodies’ involvement	N/A
Ireland	Expert involvement	EU	14	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Ireland	Expert involvement	EU	14	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Ireland	Expert involvement	EU	14	6b	Timing of expert panels’ involvement	N/A
Ireland	Reimbursement	EU	14	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Ireland	Reimbursement	EU	14	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Italy	General	EU	15	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
Italy	Fee	EU	15	2	Fee (€)	3398
Italy	Standard documentation to be submitted	EU	15	3a	Cover letter	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3b	Authorisation/application form	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3c	Investigator's Brochure	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3f	Case Report Form (CRF)	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3g	Informed Consent Form (ICF)	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3h	Proof of insurance cover	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3j	Proof of payment of the fee	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3k	Opinion of experts’ panels	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3l	CE certificates of Notified Bodies	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3m	Decisions of other Competent Authorities concerned	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3o	Recruitment procedures and advertising materials	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3p	Opinion of other Ethics Committees concerned	Yes, optional
Italy	Standard documentation to be submitted	EU	15	3q	General Device Information	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3r	Medicinal products contained in the device	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3s	List of participating countries	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3t	Trial centres list	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Italy	Standard documentation to be submitted	EU	15	3v	Compliance to ISO 14155	N/A
Italy	Standard documentation to be submitted	EU	15	3w	MRI checklist	N/A
Italy	Standard documentation to be submitted	EU	15	3x	Ionising radiation information	N/A
Italy	Standard documentation to be submitted	EU	15	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Italy	Patients' involvement	EU	15	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Italy	Patients' involvement	EU	15	4a	Brief description of the type and extent of patients’ involvement	No
Italy	Patients' involvement	EU	15	4b	Timing of patients’ involvement	No
Italy	HTA involvement	EU	15	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Italy	HTA involvement	EU	15	5a	Brief description of the type and extent of HTA bodies involvement	No
Italy	HTA involvement	EU	15	5b	Timing of HTA bodies’ involvement	No
Italy	Expert involvement	EU	15	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Italy	Expert involvement	EU	15	6a	Brief description of the type and extent of expert panels’ involvement	No
Italy	Expert involvement	EU	15	6b	Timing of expert panels’ involvement	No
Italy	Reimbursement	EU	15	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Italy	Reimbursement	EU	15	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
Latvia	General	EU	16	1	Link to the website of the procedure	N/A
Latvia	Fee	EU	16	2	Fee (€)	Initial application 1500 Substantial modification CI 900
Latvia	Standard documentation to be submitted	EU	16	3a	Cover letter	Yes, optional
Latvia	Standard documentation to be submitted	EU	16	3b	Authorisation/application form	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3c	Investigator's Brochure	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3f	Case Report Form (CRF)	No
Latvia	Standard documentation to be submitted	EU	16	3g	Informed Consent Form (ICF)	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3h	Proof of insurance cover	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3j	Proof of payment of the fee	No
Latvia	Standard documentation to be submitted	EU	16	3k	Opinion of experts’ panels	Yes, optional
Latvia	Standard documentation to be submitted	EU	16	3l	CE certificates of Notified Bodies	N/A
Latvia	Standard documentation to be submitted	EU	16	3m	Decisions of other Competent Authorities concerned	N/A
Latvia	Standard documentation to be submitted	EU	16	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Latvia	Standard documentation to be submitted	EU	16	3o	Recruitment procedures and advertising materials	N/A
Latvia	Standard documentation to be submitted	EU	16	3p	Opinion of other Ethics Committees concerned	N/A
Latvia	Standard documentation to be submitted	EU	16	3q	General Device Information	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3r	Medicinal products contained in the device	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3s	List of participating countries	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3t	Trial centres list	Yes, mandatory
Latvia	Standard documentation to be submitted	EU	16	3u	Declaration of possession of requirements for trial centres	N/A
Latvia	Standard documentation to be submitted	EU	16	3v	Compliance to ISO 14155	N/A
Latvia	Standard documentation to be submitted	EU	16	3w	MRI checklist	N/A
Latvia	Standard documentation to be submitted	EU	16	3x	Ionising radiation information	Yes, optional
Latvia	Standard documentation to be submitted	EU	16	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Latvia	Patients' involvement	EU	16	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Latvia	Patients' involvement	EU	16	4a	Brief description of the type and extent of patients’ involvement	N/A
Latvia	Patients' involvement	EU	16	4b	Timing of patients’ involvement	N/A
Latvia	HTA involvement	EU	16	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Latvia	HTA involvement	EU	16	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Latvia	HTA involvement	EU	16	5b	Timing of HTA bodies’ involvement	N/A
Latvia	Expert involvement	EU	16	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Latvia	Expert involvement	EU	16	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Latvia	Expert involvement	EU	16	6b	Timing of expert panels’ involvement	N/A
Latvia	Reimbursement	EU	16	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Latvia	Reimbursement	EU	16	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Lithuania	General	EU	17	1	Link to the website of the procedure	https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/6abb8a40302911eb8c97e01ffe050e1c/asr
Lithuania	Fee	EU	17	2	Fee (€)	1407
Lithuania	Standard documentation to be submitted	EU	17	3a	Cover letter	N/A
Lithuania	Standard documentation to be submitted	EU	17	3b	Authorisation/application form	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3c	Investigator's Brochure	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3f	Case Report Form (CRF)	N/A
Lithuania	Standard documentation to be submitted	EU	17	3g	Informed Consent Form (ICF)	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3h	Proof of insurance cover	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3j	Proof of payment of the fee	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3k	Opinion of experts’ panels	N/A
Lithuania	Standard documentation to be submitted	EU	17	3l	CE certificates of Notified Bodies	N/A
Lithuania	Standard documentation to be submitted	EU	17	3m	Decisions of other Competent Authorities concerned	N/A
Lithuania	Standard documentation to be submitted	EU	17	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Lithuania	Standard documentation to be submitted	EU	17	3o	Recruitment procedures and advertising materials	N/A
Lithuania	Standard documentation to be submitted	EU	17	3p	Opinion of other Ethics Committees concerned	N/A
Lithuania	Standard documentation to be submitted	EU	17	3q	General Device Information	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3r	Medicinal products contained in the device	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3s	List of participating countries	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3t	Trial centres list	Yes, mandatory
Lithuania	Standard documentation to be submitted	EU	17	3u	Declaration of possession of requirements for trial centres	N/A
Lithuania	Standard documentation to be submitted	EU	17	3v	Compliance to ISO 14155	N/A
Lithuania	Standard documentation to be submitted	EU	17	3w	MRI checklist	N/A
Lithuania	Standard documentation to be submitted	EU	17	3x	Ionising radiation information	Yes, optional
Lithuania	Standard documentation to be submitted	EU	17	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Lithuania	Patients' involvement	EU	17	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Lithuania	Patients' involvement	EU	17	4a	Brief description of the type and extent of patients’ involvement	N/A
Lithuania	Patients' involvement	EU	17	4b	Timing of patients’ involvement	N/A
Lithuania	HTA involvement	EU	17	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Lithuania	HTA involvement	EU	17	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Lithuania	HTA involvement	EU	17	5b	Timing of HTA bodies’ involvement	N/A
Lithuania	Expert involvement	EU	17	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Lithuania	Expert involvement	EU	17	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Lithuania	Expert involvement	EU	17	6b	Timing of expert panels’ involvement	N/A
Lithuania	Reimbursement	EU	17	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Lithuania	Reimbursement	EU	17	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Luxembourg	General	EU	18	1	Link to the website of the procedure	https://sante.public.lu/fr/espace-professionnel/domaines/recherche-biomedicale/investigation-clinique-dispositifs-medicaux.html
Luxembourg	Fee	EU	18	2	Fee (€)	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3a	Cover letter	No
Luxembourg	Standard documentation to be submitted	EU	18	3b	Authorisation/application form	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3c	Investigator's Brochure	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3e	Copy of the opinion of the ethics committee	No
Luxembourg	Standard documentation to be submitted	EU	18	3f	Case Report Form (CRF)	No
Luxembourg	Standard documentation to be submitted	EU	18	3g	Informed Consent Form (ICF)	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3h	Proof of insurance cover	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3j	Proof of payment of the fee	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3k	Opinion of experts’ panels	Yes, optional
Luxembourg	Standard documentation to be submitted	EU	18	3l	CE certificates of Notified Bodies	Yes, optional
Luxembourg	Standard documentation to be submitted	EU	18	3m	Decisions of other Competent Authorities concerned	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3n	Post Market Clinical Follow-up (PMCF) plan	No
Luxembourg	Standard documentation to be submitted	EU	18	3o	Recruitment procedures and advertising materials	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3p	Opinion of other Ethics Committees concerned	No
Luxembourg	Standard documentation to be submitted	EU	18	3q	General Device Information	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3r	Medicinal products contained in the device	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3s	List of participating countries	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3t	Trial centres list	Yes, mandatory
Luxembourg	Standard documentation to be submitted	EU	18	3u	Declaration of possession of requirements for trial centres	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3v	Compliance to ISO 14155	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3w	MRI checklist	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3x	Ionising radiation information	N/A
Luxembourg	Standard documentation to be submitted	EU	18	3y	Serious Adverse Event (SAE) Report Form	N/A
Luxembourg	Patients' involvement	EU	18	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Luxembourg	Patients' involvement	EU	18	4a	Brief description of the type and extent of patients’ involvement	N/A
Luxembourg	Patients' involvement	EU	18	4b	Timing of patients’ involvement	N/A
Luxembourg	HTA involvement	EU	18	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Luxembourg	HTA involvement	EU	18	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Luxembourg	HTA involvement	EU	18	5b	Timing of HTA bodies’ involvement	N/A
Luxembourg	Expert involvement	EU	18	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Luxembourg	Expert involvement	EU	18	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Luxembourg	Expert involvement	EU	18	6b	Timing of expert panels’ involvement	N/A
Luxembourg	Reimbursement	EU	18	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Luxembourg	Reimbursement	EU	18	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Malta	General	EU	19	1	Link to the website of the procedure	Medicines Authority (gov.mt)
Malta	Fee	EU	19	2	Fee (€)	5000
Malta	Standard documentation to be submitted	EU	19	3a	Cover letter	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3b	Authorisation/application form	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3c	Investigator's Brochure	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3f	Case Report Form (CRF)	N/A
Malta	Standard documentation to be submitted	EU	19	3g	Informed Consent Form (ICF)	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3h	Proof of insurance cover	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3j	Proof of payment of the fee	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3k	Opinion of experts’ panels	Yes, optional
Malta	Standard documentation to be submitted	EU	19	3l	CE certificates of Notified Bodies	Yes, optional
Malta	Standard documentation to be submitted	EU	19	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Malta	Standard documentation to be submitted	EU	19	3o	Recruitment procedures and advertising materials	Yes, optional
Malta	Standard documentation to be submitted	EU	19	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3q	General Device Information	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3r	Medicinal products contained in the device	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3s	List of participating countries	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3t	Trial centres list	Yes, mandatory
Malta	Standard documentation to be submitted	EU	19	3u	Declaration of possession of requirements for trial centres	N/A
Malta	Standard documentation to be submitted	EU	19	3v	Compliance to ISO 14155	N/A
Malta	Standard documentation to be submitted	EU	19	3w	MRI checklist	N/A
Malta	Standard documentation to be submitted	EU	19	3x	Ionising radiation information	N/A
Malta	Standard documentation to be submitted	EU	19	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Malta	Patients' involvement	EU	19	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Malta	Patients' involvement	EU	19	4a	Brief description of the type and extent of patients’ involvement	N/A
Malta	Patients' involvement	EU	19	4b	Timing of patients’ involvement	N/A
Malta	HTA involvement	EU	19	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Malta	HTA involvement	EU	19	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Malta	HTA involvement	EU	19	5b	Timing of HTA bodies’ involvement	N/A
Malta	Expert involvement	EU	19	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Malta	Expert involvement	EU	19	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Malta	Expert involvement	EU	19	6b	Timing of expert panels’ involvement	N/A
Malta	Reimbursement	EU	19	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Malta	Reimbursement	EU	19	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Netherlands	General	EU	20	1	Link to the website of the procedure	https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices/primary-submission-investigations-with-medical-devices
Netherlands	Fee	EU	20	2	Fee (€)	Initial application 7320 Device modification 2440
Netherlands	Standard documentation to be submitted	EU	20	3a	Cover letter	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3b	Authorisation/application form	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3c	Investigator's Brochure	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3e	Copy of the opinion of the ethics committee	N/A
Netherlands	Standard documentation to be submitted	EU	20	3f	Case Report Form (CRF)	N/A
Netherlands	Standard documentation to be submitted	EU	20	3g	Informed Consent Form (ICF)	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3h	Proof of insurance cover	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3j	Proof of payment of the fee	N/A
Netherlands	Standard documentation to be submitted	EU	20	3k	Opinion of experts’ panels	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3l	CE certificates of Notified Bodies	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3m	Decisions of other Competent Authorities concerned	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3o	Recruitment procedures and advertising materials	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3p	Opinion of other Ethics Committees concerned	N/A
Netherlands	Standard documentation to be submitted	EU	20	3q	General Device Information	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3r	Medicinal products contained in the device	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3s	List of participating countries	N/A
Netherlands	Standard documentation to be submitted	EU	20	3t	Trial centres list	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Netherlands	Standard documentation to be submitted	EU	20	3v	Compliance to ISO 14155	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3w	MRI checklist	N/A
Netherlands	Standard documentation to be submitted	EU	20	3x	Ionising radiation information	Yes, optional
Netherlands	Standard documentation to be submitted	EU	20	3y	Serious Adverse Event (SAE) Report Form	N/A
Netherlands	Patients' involvement	EU	20	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Netherlands	Patients' involvement	EU	20	4a	Brief description of the type and extent of patients’ involvement	N/A
Netherlands	Patients' involvement	EU	20	4b	Timing of patients’ involvement	N/A
Netherlands	HTA involvement	EU	20	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Netherlands	HTA involvement	EU	20	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Netherlands	HTA involvement	EU	20	5b	Timing of HTA bodies’ involvement	N/A
Netherlands	Expert involvement	EU	20	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Netherlands	Expert involvement	EU	20	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Netherlands	Expert involvement	EU	20	6b	Timing of expert panels’ involvement	N/A
Netherlands	Reimbursement	EU	20	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Netherlands	Reimbursement	EU	20	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Poland	General	EU	21	1	Link to the website of the procedure	N/A
Poland	Fee	EU	21	2	Fee (€)	Initial application 1404.78 Substantial amendments 475
Poland	Standard documentation to be submitted	EU	21	3a	Cover letter	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3b	Authorisation/application form	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3c	Investigator's Brochure	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3e	Copy of the opinion of the ethics committee	Yes
Poland	Standard documentation to be submitted	EU	21	3f	Case Report Form (CRF)	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3g	Informed Consent Form (ICF)	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3h	Proof of insurance cover	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes
Poland	Standard documentation to be submitted	EU	21	3j	Proof of payment of the fee	Yes
Poland	Standard documentation to be submitted	EU	21	3k	Opinion of experts’ panels	N/A
Poland	Standard documentation to be submitted	EU	21	3l	CE certificates of Notified Bodies	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3m	Decisions of other Competent Authorities concerned	Yes, optional
Poland	Standard documentation to be submitted	EU	21	3n	Post Market Clinical Follow-up (PMCF) plan	No
Poland	Standard documentation to be submitted	EU	21	3o	Recruitment procedures and advertising materials	Yes, optional
Poland	Standard documentation to be submitted	EU	21	3p	Opinion of other Ethics Committees concerned	No
Poland	Standard documentation to be submitted	EU	21	3q	General Device Information	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3r	Medicinal products contained in the device	If applicable
Poland	Standard documentation to be submitted	EU	21	3s	List of participating countries	Yes
Poland	Standard documentation to be submitted	EU	21	3t	Trial centres list	Yes, optional
Poland	Standard documentation to be submitted	EU	21	3u	Declaration of possession of requirements for trial centres	Yes, optional
Poland	Standard documentation to be submitted	EU	21	3v	Compliance to ISO 14155	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3w	MRI checklist	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3x	Ionising radiation information	Yes, mandatory
Poland	Standard documentation to be submitted	EU	21	3y	Serious Adverse Event (SAE) Report Form	No
Poland	Patients' involvement	EU	21	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Poland	Patients' involvement	EU	21	4a	Brief description of the type and extent of patients’ involvement	N/A
Poland	Patients' involvement	EU	21	4b	Timing of patients’ involvement	N/A
Poland	HTA involvement	EU	21	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Poland	HTA involvement	EU	21	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Poland	HTA involvement	EU	21	5b	Timing of HTA bodies’ involvement	N/A
Poland	Expert involvement	EU	21	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Poland	Expert involvement	EU	21	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Poland	Expert involvement	EU	21	6b	Timing of expert panels’ involvement	N/A
Poland	Reimbursement	EU	21	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Poland	Reimbursement	EU	21	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Portugal	General	EU	22	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-
Portugal	Fee	EU	22	2	Fee (€)	1000
Portugal	Standard documentation to be submitted	EU	22	3a	Cover letter	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3b	Authorisation/application form	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3c	Investigator's Brochure	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3e	Copy of the opinion of the ethics committee	No
Portugal	Standard documentation to be submitted	EU	22	3f	Case Report Form (CRF)	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3g	Informed Consent Form (ICF)	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3h	Proof of insurance cover	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3j	Proof of payment of the fee	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3k	Opinion of experts’ panels	Yes, optional
Portugal	Standard documentation to be submitted	EU	22	3l	CE certificates of Notified Bodies	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3m	Decisions of other Competent Authorities concerned	Yes, optional
Portugal	Standard documentation to be submitted	EU	22	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3o	Recruitment procedures and advertising materials	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3p	Opinion of other Ethics Committees concerned	N/A
Portugal	Standard documentation to be submitted	EU	22	3q	General Device Information	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3r	Medicinal products contained in the device	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3s	List of participating countries	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3t	Trial centres list	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3u	Declaration of possession of requirements for trial centres	No
Portugal	Standard documentation to be submitted	EU	22	3v	Compliance to ISO 14155	Yes, mandatory
Portugal	Standard documentation to be submitted	EU	22	3w	MRI checklist	N/A
Portugal	Standard documentation to be submitted	EU	22	3x	Ionising radiation information	N/A
Portugal	Standard documentation to be submitted	EU	22	3y	Serious Adverse Event (SAE) Report Form	N/A
Portugal	Patients' involvement	EU	22	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Portugal	Patients' involvement	EU	22	4a	Brief description of the type and extent of patients’ involvement	No
Portugal	Patients' involvement	EU	22	4b	Timing of patients’ involvement	No
Portugal	HTA involvement	EU	22	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Portugal	HTA involvement	EU	22	5a	Brief description of the type and extent of HTA bodies involvement	No
Portugal	HTA involvement	EU	22	5b	Timing of HTA bodies’ involvement	No
Portugal	Expert involvement	EU	22	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Portugal	Expert involvement	EU	22	6a	Brief description of the type and extent of expert panels’ involvement	No
Portugal	Expert involvement	EU	22	6b	Timing of expert panels’ involvement	No
Portugal	Reimbursement	EU	22	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Portugal	Reimbursement	EU	22	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
Romania	General	EU	23	1	Link to the website of the procedure	N/A
Romania	Fee	EU	23	2	Fee (€)	I/IIa 1754 IIa/IIb non-invasive 3606 IIb invasive/III 4090
Romania	Standard documentation to be submitted	EU	23	3a	Cover letter	N/A
Romania	Standard documentation to be submitted	EU	23	3b	Authorisation/application form	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3c	Investigator's Brochure	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3f	Case Report Form (CRF)	N/A
Romania	Standard documentation to be submitted	EU	23	3g	Informed Consent Form (ICF)	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3h	Proof of insurance cover	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Romania	Standard documentation to be submitted	EU	23	3j	Proof of payment of the fee	N/A
Romania	Standard documentation to be submitted	EU	23	3k	Opinion of experts’ panels	N/A
Romania	Standard documentation to be submitted	EU	23	3l	CE certificates of Notified Bodies	N/A
Romania	Standard documentation to be submitted	EU	23	3m	Decisions of other Competent Authorities concerned	N/A
Romania	Standard documentation to be submitted	EU	23	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Romania	Standard documentation to be submitted	EU	23	3o	Recruitment procedures and advertising materials	N/A
Romania	Standard documentation to be submitted	EU	23	3p	Opinion of other Ethics Committees concerned	N/A
Romania	Standard documentation to be submitted	EU	23	3q	General Device Information	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3r	Medicinal products contained in the device	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3s	List of participating countries	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3t	Trial centres list	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3u	Declaration of possession of requirements for trial centres	N/A
Romania	Standard documentation to be submitted	EU	23	3v	Compliance to ISO 14155	Yes, mandatory
Romania	Standard documentation to be submitted	EU	23	3w	MRI checklist	N/A
Romania	Standard documentation to be submitted	EU	23	3x	Ionising radiation information	N/A
Romania	Standard documentation to be submitted	EU	23	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Romania	Patients' involvement	EU	23	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Romania	Patients' involvement	EU	23	4a	Brief description of the type and extent of patients’ involvement	N/A
Romania	Patients' involvement	EU	23	4b	Timing of patients’ involvement	N/A
Romania	HTA involvement	EU	23	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Romania	HTA involvement	EU	23	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Romania	HTA involvement	EU	23	5b	Timing of HTA bodies’ involvement	N/A
Romania	Expert involvement	EU	23	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Romania	Expert involvement	EU	23	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Romania	Expert involvement	EU	23	6b	Timing of expert panels’ involvement	N/A
Romania	Reimbursement	EU	23	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Romania	Reimbursement	EU	23	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Slovakia	General	EU	24	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
Slovakia	Fee	EU	24	2	Fee (€)	500
Slovakia	Standard documentation to be submitted	EU	24	3a	Cover letter	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3b	Authorisation/application form	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3c	Investigator's Brochure	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3e	Copy of the opinion of the ethics committee	Yes, optional
Slovakia	Standard documentation to be submitted	EU	24	3f	Case Report Form (CRF)	N/A
Slovakia	Standard documentation to be submitted	EU	24	3g	Informed Consent Form (ICF)	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3h	Proof of insurance cover	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3j	Proof of payment of the fee	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3k	Opinion of experts’ panels	N/A
Slovakia	Standard documentation to be submitted	EU	24	3l	CE certificates of Notified Bodies	N/A
Slovakia	Standard documentation to be submitted	EU	24	3m	Decisions of other Competent Authorities concerned	N/A
Slovakia	Standard documentation to be submitted	EU	24	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Slovakia	Standard documentation to be submitted	EU	24	3o	Recruitment procedures and advertising materials	N/A
Slovakia	Standard documentation to be submitted	EU	24	3p	Opinion of other Ethics Committees concerned	Yes, optional
Slovakia	Standard documentation to be submitted	EU	24	3q	General Device Information	N/A
Slovakia	Standard documentation to be submitted	EU	24	3r	Medicinal products contained in the device	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3s	List of participating countries	N/A
Slovakia	Standard documentation to be submitted	EU	24	3t	Trial centres list	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Slovakia	Standard documentation to be submitted	EU	24	3v	Compliance to ISO 14155	N/A
Slovakia	Standard documentation to be submitted	EU	24	3w	MRI checklist	N/A
Slovakia	Standard documentation to be submitted	EU	24	3x	Ionising radiation information	N/A
Slovakia	Standard documentation to be submitted	EU	24	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Slovakia	Patients' involvement	EU	24	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovakia	Patients' involvement	EU	24	4a	Brief description of the type and extent of patients’ involvement	N/A
Slovakia	Patients' involvement	EU	24	4b	Timing of patients’ involvement	N/A
Slovakia	HTA involvement	EU	24	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovakia	HTA involvement	EU	24	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Slovakia	HTA involvement	EU	24	5b	Timing of HTA bodies’ involvement	N/A
Slovakia	Expert involvement	EU	24	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovakia	Expert involvement	EU	24	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Slovakia	Expert involvement	EU	24	6b	Timing of expert panels’ involvement	N/A
Slovakia	Reimbursement	EU	24	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Slovakia	Reimbursement	EU	24	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Slovenia	General	EU	25	1	Link to the website of the procedure	https://www.jazmp.si/en/medical-devices/clinical-investigations/
Slovenia	Fee	EU	25	2	Fee (€)	I/IIa 3800 IIb/III 4175
Slovenia	Standard documentation to be submitted	EU	25	3a	Cover letter	N/A
Slovenia	Standard documentation to be submitted	EU	25	3b	Authorisation/application form	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3c	Investigator's Brochure	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3f	Case Report Form (CRF)	N/A
Slovenia	Standard documentation to be submitted	EU	25	3g	Informed Consent Form (ICF)	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3h	Proof of insurance cover	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3j	Proof of payment of the fee	N/A
Slovenia	Standard documentation to be submitted	EU	25	3k	Opinion of experts’ panels	N/A
Slovenia	Standard documentation to be submitted	EU	25	3l	CE certificates of Notified Bodies	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3m	Decisions of other Competent Authorities concerned	N/A
Slovenia	Standard documentation to be submitted	EU	25	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3o	Recruitment procedures and advertising materials	N/A
Slovenia	Standard documentation to be submitted	EU	25	3p	Opinion of other Ethics Committees concerned	N/A
Slovenia	Standard documentation to be submitted	EU	25	3q	General Device Information	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3r	Medicinal products contained in the device	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3s	List of participating countries	N/A
Slovenia	Standard documentation to be submitted	EU	25	3t	Trial centres list	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3u	Declaration of possession of requirements for trial centres	N/A
Slovenia	Standard documentation to be submitted	EU	25	3v	Compliance to ISO 14155	Yes, mandatory
Slovenia	Standard documentation to be submitted	EU	25	3w	MRI checklist	N/A
Slovenia	Standard documentation to be submitted	EU	25	3x	Ionising radiation information	N/A
Slovenia	Standard documentation to be submitted	EU	25	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
Slovenia	Patients' involvement	EU	25	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovenia	Patients' involvement	EU	25	4a	Brief description of the type and extent of patients’ involvement	N/A
Slovenia	Patients' involvement	EU	25	4b	Timing of patients’ involvement	N/A
Slovenia	HTA involvement	EU	25	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovenia	HTA involvement	EU	25	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Slovenia	HTA involvement	EU	25	5b	Timing of HTA bodies’ involvement	N/A
Slovenia	Expert involvement	EU	25	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Slovenia	Expert involvement	EU	25	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Slovenia	Expert involvement	EU	25	6b	Timing of expert panels’ involvement	N/A
Slovenia	Reimbursement	EU	25	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Slovenia	Reimbursement	EU	25	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Spain	General	EU	26	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/
Spain	Fee	EU	26	2	Fee (€)	1554
Spain	Standard documentation to be submitted	EU	26	3a	Cover letter	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3b	Authorisation/application form	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3c	Investigator's Brochure	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3f	Case Report Form (CRF)	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3g	Informed Consent Form (ICF)	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3h	Proof of insurance cover	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
Spain	Standard documentation to be submitted	EU	26	3j	Proof of payment of the fee	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3k	Opinion of experts’ panels	N/A
Spain	Standard documentation to be submitted	EU	26	3l	CE certificates of Notified Bodies	N/A
Spain	Standard documentation to be submitted	EU	26	3m	Decisions of other Competent Authorities concerned	No
Spain	Standard documentation to be submitted	EU	26	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, optional
Spain	Standard documentation to be submitted	EU	26	3o	Recruitment procedures and advertising materials	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3p	Opinion of other Ethics Committees concerned	No
Spain	Standard documentation to be submitted	EU	26	3q	General Device Information	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3r	Medicinal products contained in the device	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3s	List of participating countries	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3t	Declaration of possession of requirements for trial centres	Yes, optional
Spain	Standard documentation to be submitted	EU	26	3u	Trial centres list	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3v	Compliance to ISO 14155	No
Spain	Standard documentation to be submitted	EU	26	3w	MRI checklist	No
Spain	Standard documentation to be submitted	EU	26	3x	Ionising radiation information	Yes, mandatory
Spain	Standard documentation to be submitted	EU	26	3y	Serious Adverse Event (SAE) Report Form	No
Spain	Patients' involvement	EU	26	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Spain	Patients' involvement	EU	26	4a	Brief description of the type and extent of patients’ involvement	N/A
Spain	Patients' involvement	EU	26	4b	Timing of patients’ involvement	N/A
Spain	HTA involvement	EU	26	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Spain	HTA involvement	EU	26	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Spain	HTA involvement	EU	26	5b	Timing of HTA bodies’ involvement	N/A
Spain	Expert involvement	EU	26	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Spain	Expert involvement	EU	26	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Spain	Expert involvement	EU	26	6b	Timing of expert panels’ involvement	N/A
Spain	Reimbursement	EU	26	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Spain	Reimbursement	EU	26	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Sweden	General	EU	27	1	Link to the website of the procedure	N/A
Sweden	Fee	EU	27	2	Fee (€)	I/non-invasive IIa/IIb 2150 III/invasive IIa/IIb 5160
Sweden	Standard documentation to be submitted	EU	27	3a	Cover letter	N/A
Sweden	Standard documentation to be submitted	EU	27	3b	Authorisation/application form	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3c	Investigator's Brochure	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3f	Case Report Form (CRF)	N/A
Sweden	Standard documentation to be submitted	EU	27	3g	Informed Consent Form (ICF)	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3h	Proof of insurance cover	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3j	Proof of payment of the fee	Yes, mandatory
Sweden	Standard documentation to be submitted	EU	27	3k	Opinion of experts’ panels	N/A
Sweden	Standard documentation to be submitted	EU	27	3l	CE certificates of Notified Bodies	N/A
Sweden	Standard documentation to be submitted	EU	27	3m	Decisions of other Competent Authorities concerned	N/A
Sweden	Standard documentation to be submitted	EU	27	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Sweden	Standard documentation to be submitted	EU	27	3o	Recruitment procedures and advertising materials	N/A
Sweden	Standard documentation to be submitted	EU	27	3p	Opinion of other Ethics Committees concerned	N/A
Sweden	Standard documentation to be submitted	EU	27	3q	General Device Information	N/A
Sweden	Standard documentation to be submitted	EU	27	3r	Medicinal products contained in the device	N/A
Sweden	Standard documentation to be submitted	EU	27	3s	List of participating countries	N/A
Sweden	Standard documentation to be submitted	EU	27	3t	Trial centres list	N/A
Sweden	Standard documentation to be submitted	EU	27	3u	Declaration of possession of requirements for trial centres	N/A
Sweden	Standard documentation to be submitted	EU	27	3v	Compliance to ISO 14155	N/A
Sweden	Standard documentation to be submitted	EU	27	3w	MRI checklist	N/A
Sweden	Standard documentation to be submitted	EU	27	3x	Ionising radiation information	N/A
Sweden	Standard documentation to be submitted	EU	27	3y	Serious Adverse Event (SAE) Report Form	N/A
Sweden	Patients' involvement	EU	27	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Sweden	Patients' involvement	EU	27	4a	Brief description of the type and extent of patients’ involvement	N/A
Sweden	Patients' involvement	EU	27	4b	Timing of patients’ involvement	N/A
Sweden	HTA involvement	EU	27	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Sweden	HTA involvement	EU	27	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Sweden	HTA involvement	EU	27	5b	Timing of HTA bodies’ involvement	N/A
Sweden	Expert involvement	EU	27	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Sweden	Expert involvement	EU	27	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Sweden	Expert involvement	EU	27	6b	Timing of expert panels’ involvement	N/A
Sweden	Reimbursement	EU	27	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Sweden	Reimbursement	EU	27	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Iceland	General	EEA	28	1	Link to the website of the procedure	https://www.lyfjastofnun.is/laekningataeki/kliniskar-profanir-a-laekningataekjum/
Iceland	Fee	EEA	28	2	Fee (€)	N/A
Iceland	Standard documentation to be submitted	EEA	28	3a	Cover letter	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3b	Authorisation/application form	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3c	Investigator's Brochure	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3f	Case Report Form (CRF)	N/A
Iceland	Standard documentation to be submitted	EEA	28	3g	Informed Consent Form (ICF)	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3h	Proof of insurance cover	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3j	Proof of payment of the fee	N/A
Iceland	Standard documentation to be submitted	EEA	28	3k	Opinion of experts’ panels	N/A
Iceland	Standard documentation to be submitted	EEA	28	3l	CE certificates of Notified Bodies	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3m	Decisions of other Competent Authorities concerned	N/A
Iceland	Standard documentation to be submitted	EEA	28	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3o	Recruitment procedures and advertising materials	N/A
Iceland	Standard documentation to be submitted	EEA	28	3p	Opinion of other Ethics Committees concerned	N/A
Iceland	Standard documentation to be submitted	EEA	28	3q	General Device Information	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3r	Medicinal products contained in the device	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3s	List of participating countries	N/A
Iceland	Standard documentation to be submitted	EEA	28	3t	Trial centres list	Yes, mandatory
Iceland	Standard documentation to be submitted	EEA	28	3u	Declaration of possession of requirements for trial centres	N/A
Iceland	Standard documentation to be submitted	EEA	28	3v	Compliance to ISO 14155	N/A
Iceland	Standard documentation to be submitted	EEA	28	3w	MRI checklist	N/A
Iceland	Standard documentation to be submitted	EEA	28	3x	Ionising radiation information	N/A
Iceland	Standard documentation to be submitted	EEA	28	3y	Serious Adverse Event (SAE) Report Form	N/A
Iceland	Patients' involvement	EEA	28	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Iceland	Patients' involvement	EEA	28	4a	Brief description of the type and extent of patients’ involvement	N/A
Iceland	Patients' involvement	EEA	28	4b	Timing of patients’ involvement	N/A
Iceland	HTA involvement	EEA	28	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Iceland	HTA involvement	EEA	28	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Iceland	HTA involvement	EEA	28	5b	Timing of HTA bodies’ involvement	N/A
Iceland	Expert involvement	EEA	28	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Iceland	Expert involvement	EEA	28	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Iceland	Expert involvement	EEA	28	6b	Timing of expert panels’ involvement	N/A
Iceland	Reimbursement	EEA	28	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Iceland	Reimbursement	EEA	28	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Liechtenstein	General	EEA	29	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
Liechtenstein	Fee	EEA	29	2	Fee (€)	5312
Liechtenstein	Standard documentation to be submitted	EEA	29	3a	Cover letter	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3b	Authorisation/application form	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3c	Investigator's Brochure	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3f	Case Report Form (CRF)	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3g	Informed Consent Form (ICF)	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3h	Proof of insurance cover	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3j	Proof of payment of the fee	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3k	Opinion of experts’ panels	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3l	CE certificates of Notified Bodies	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3m	Decisions of other Competent Authorities concerned	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3o	Recruitment procedures and advertising materials	No
Liechtenstein	Standard documentation to be submitted	EEA	29	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3q	General Device Information	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3r	Medicinal products contained in the device	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3s	List of participating countries	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3t	Trial centres list	Yes, mandatory
Liechtenstein	Standard documentation to be submitted	EEA	29	3u	Declaration of possession of requirements for trial centres	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3v	Compliance to ISO 14155	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3w	MRI checklist	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3x	Ionising radiation information	N/A
Liechtenstein	Standard documentation to be submitted	EEA	29	3y	Serious Adverse Event (SAE) Report Form	N/A
Liechtenstein	Patients' involvement	EEA	29	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Liechtenstein	Patients' involvement	EEA	29	4a	Brief description of the type and extent of patients’ involvement	N/A
Liechtenstein	Patients' involvement	EEA	29	4b	Timing of patients’ involvement	N/A
Liechtenstein	HTA involvement	EEA	29	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Liechtenstein	HTA involvement	EEA	29	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Liechtenstein	HTA involvement	EEA	29	5b	Timing of HTA bodies’ involvement	N/A
Liechtenstein	Expert involvement	EEA	29	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Liechtenstein	Expert involvement	EEA	29	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Liechtenstein	Expert involvement	EEA	29	6b	Timing of expert panels’ involvement	N/A
Liechtenstein	Reimbursement	EEA	29	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Liechtenstein	Reimbursement	EEA	29	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Norway	General	EEA	30	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
Norway	Fee	EEA	30	2	Fee (€)	N/A
Norway	Standard documentation to be submitted	EEA	30	3a	Cover letter	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3b	Authorisation/application form	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3c	Investigator's Brochure	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3f	Case Report Form (CRF)	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3g	Informed Consent Form (ICF)	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3h	Proof of insurance cover	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3j	Proof of payment of the fee	N/A
Norway	Standard documentation to be submitted	EEA	30	3k	Opinion of experts’ panels	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3l	CE certificates of Notified Bodies	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3m	Decisions of other Competent Authorities concerned	N/A
Norway	Standard documentation to be submitted	EEA	30	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3o	Recruitment procedures and advertising materials	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3q	General Device Information	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3r	Medicinal products contained in the device	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3s	List of participating countries	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3t	Trial centres list	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3v	Compliance to ISO 14155	Yes, mandatory
Norway	Standard documentation to be submitted	EEA	30	3w	MRI checklist	N/A
Norway	Standard documentation to be submitted	EEA	30	3x	Ionising radiation information	N/A
Norway	Standard documentation to be submitted	EEA	30	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Norway	Patients' involvement	EEA	30	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Norway	Patients' involvement	EEA	30	4a	Brief description of the type and extent of patients’ involvement	No
Norway	Patients' involvement	EEA	30	4b	Timing of patients’ involvement	No
Norway	HTA involvement	EEA	30	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Norway	HTA involvement	EEA	30	5a	Brief description of the type and extent of HTA bodies involvement	No
Norway	HTA involvement	EEA	30	5b	Timing of HTA bodies’ involvement	No
Norway	Expert involvement	EEA	30	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	Yes, optional
Norway	Expert involvement	EEA	30	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.
Norway	Expert involvement	EEA	30	6b	Timing of expert panels’ involvement	No
Norway	Reimbursement	EEA	30	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Norway	Reimbursement	EEA	30	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	No
Albania	General	EMEA	31	1	Link to the website of the procedure	https://akbpm.gov.al/wp-content/uploads/2019/08/Ligji-i-pajisjeve-mjekesore-2.pdf
Albania	Fee	EMEA	31	2	Fee (€)	5
Albania	Standard documentation to be submitted	EMEA	31	3a	Cover letter	No
Albania	Standard documentation to be submitted	EMEA	31	3b	Authorisation/application form	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3c	Investigator's Brochure	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3f	Case Report Form (CRF)	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3g	Informed Consent Form (ICF)	N/A
Albania	Standard documentation to be submitted	EMEA	31	3h	Proof of insurance cover	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3j	Proof of payment of the fee	No
Albania	Standard documentation to be submitted	EMEA	31	3k	Opinion of experts’ panels	No
Albania	Standard documentation to be submitted	EMEA	31	3l	CE certificates of Notified Bodies	Yes, optional
Albania	Standard documentation to be submitted	EMEA	31	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Albania	Standard documentation to be submitted	EMEA	31	3o	Recruitment procedures and advertising materials	N/A
Albania	Standard documentation to be submitted	EMEA	31	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3q	General Device Information	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3r	Medicinal products contained in the device	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3s	List of participating countries	N/A
Albania	Standard documentation to be submitted	EMEA	31	3t	Trial centres list	Yes, mandatory
Albania	Standard documentation to be submitted	EMEA	31	3u	Declaration of possession of requirements for trial centres	N/A
Albania	Standard documentation to be submitted	EMEA	31	3v	Compliance to ISO 14155	N/A
Albania	Standard documentation to be submitted	EMEA	31	3w	MRI checklist	N/A
Albania	Standard documentation to be submitted	EMEA	31	3x	Ionising radiation information	N/A
Albania	Standard documentation to be submitted	EMEA	31	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Albania	Patients' involvement	EMEA	31	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Albania	Patients' involvement	EMEA	31	4a	Brief description of the type and extent of patients’ involvement	N/A
Albania	Patients' involvement	EMEA	31	4b	Timing of patients’ involvement	N/A
Albania	HTA involvement	EMEA	31	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Albania	HTA involvement	EMEA	31	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Albania	HTA involvement	EMEA	31	5b	Timing of HTA bodies’ involvement	N/A
Albania	Expert involvement	EMEA	31	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Albania	Expert involvement	EMEA	31	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Albania	Expert involvement	EMEA	31	6b	Timing of expert panels’ involvement	N/A
Albania	Reimbursement	EMEA	31	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Albania	Reimbursement	EMEA	31	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Georgia	General	EMEA	32	1	Link to the website of the procedure	N/A
Georgia	Fee	EMEA	32	2	Fee (€)	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3a	Cover letter	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3b	Authorisation/application form	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3c	Investigator's Brochure	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3e	Copy of the opinion of the ethics committee	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3f	Case Report Form (CRF)	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3g	Informed Consent Form (ICF)	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3h	Proof of insurance cover	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3j	Proof of payment of the fee	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3k	Opinion of experts’ panels	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3l	CE certificates of Notified Bodies	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3m	Decisions of other Competent Authorities concerned	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3o	Recruitment procedures and advertising materials	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3p	Opinion of other Ethics Committees concerned	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3q	General Device Information	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3r	Medicinal products contained in the device	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3s	List of participating countries	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3t	Trial centres list	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Georgia	Standard documentation to be submitted	EMEA	32	3v	Compliance to ISO 14155	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3w	MRI checklist	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3x	Ionising radiation information	N/A
Georgia	Standard documentation to be submitted	EMEA	32	3y	Serious Adverse Event (SAE) Report Form	N/A
Georgia	Patients' involvement	EMEA	32	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Georgia	Patients' involvement	EMEA	32	4a	Brief description of the type and extent of patients’ involvement	N/A
Georgia	Patients' involvement	EMEA	32	4b	Timing of patients’ involvement	N/A
Georgia	HTA involvement	EMEA	32	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Georgia	HTA involvement	EMEA	32	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Georgia	HTA involvement	EMEA	32	5b	Timing of HTA bodies’ involvement	N/A
Georgia	Expert involvement	EMEA	32	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Georgia	Expert involvement	EMEA	32	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Georgia	Expert involvement	EMEA	32	6b	Timing of expert panels’ involvement	N/A
Georgia	Reimbursement	EMEA	32	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Georgia	Reimbursement	EMEA	32	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Israel	General	EMEA	33	1	Link to the website of the procedure	https://www.gov.il/BlobFolder/generalpage/ct-roadmap/he/units_clinical-trials_roadmap.pdf
Israel	Fee	EMEA	33	2	Fee (€)	No fee
Israel	Standard documentation to be submitted	EMEA	33	3a	Cover letter	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3b	Authorisation/application form	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3c	Investigator's Brochure	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3f	Case Report Form (CRF)	No
Israel	Standard documentation to be submitted	EMEA	33	3g	Informed Consent Form (ICF)	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3h	Proof of insurance cover	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Israel	Standard documentation to be submitted	EMEA	33	3j	Proof of payment of the fee	N/A
Israel	Standard documentation to be submitted	EMEA	33	3k	Opinion of experts’ panels	No
Israel	Standard documentation to be submitted	EMEA	33	3l	CE certificates of Notified Bodies	No
Israel	Standard documentation to be submitted	EMEA	33	3m	Decisions of other Competent Authorities concerned	No
Israel	Standard documentation to be submitted	EMEA	33	3n	Post Market Clinical Follow-up (PMCF) plan	No
Israel	Standard documentation to be submitted	EMEA	33	3o	Recruitment procedures and advertising materials	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3p	Opinion of other Ethics Committees concerned	No
Israel	Standard documentation to be submitted	EMEA	33	3q	General Device Information	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3r	Medicinal products contained in the device	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3s	List of participating countries	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3t	Trial centres list	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3u	Declaration of possession of requirements for trial centres	No
Israel	Standard documentation to be submitted	EMEA	33	3v	Compliance to ISO 14155	Yes, mandatory
Israel	Standard documentation to be submitted	EMEA	33	3w	MRI checklist	No
Israel	Standard documentation to be submitted	EMEA	33	3x	Ionising radiation information	No
Israel	Standard documentation to be submitted	EMEA	33	3y	Serious Adverse Event (SAE) Report Form	No
Israel	Patients' involvement	EMEA	33	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Israel	Patients' involvement	EMEA	33	4a	Brief description of the type and extent of patients’ involvement	N/A
Israel	Patients' involvement	EMEA	33	4b	Timing of patients’ involvement	N/A
Israel	HTA involvement	EMEA	33	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Israel	HTA involvement	EMEA	33	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Israel	HTA involvement	EMEA	33	5b	Timing of HTA bodies’ involvement	N/A
Israel	Expert involvement	EMEA	33	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Israel	Expert involvement	EMEA	33	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Israel	Expert involvement	EMEA	33	6b	Timing of expert panels’ involvement	N/A
Israel	Reimbursement	EMEA	33	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Israel	Reimbursement	EMEA	33	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Kazakhstan	General	EMEA	34	1	Link to the website of the procedure	https://adilet.zan.kz/kaz/docs/V2000021772#z10
Kazakhstan	Fee	EMEA	34	2	Fee (€)	No fee
Kazakhstan	Standard documentation to be submitted	EMEA	34	3a	Cover letter	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3b	Authorisation/application form	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3c	Investigator's Brochure	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3f	Case Report Form (CRF)	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3g	Informed Consent Form (ICF)	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3h	Proof of insurance cover	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3j	Proof of payment of the fee	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3k	Opinion of experts’ panels	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3l	CE certificates of Notified Bodies	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3m	Decisions of other Competent Authorities concerned	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3o	Recruitment procedures and advertising materials	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3p	Opinion of other Ethics Committees concerned	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3q	General Device Information	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3r	Medicinal products contained in the device	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3s	List of participating countries	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3t	Trial centres list	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3u	Declaration of possession of requirements for trial centres	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3v	Compliance to ISO 14155	Yes, mandatory
Kazakhstan	Standard documentation to be submitted	EMEA	34	3w	MRI checklist	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3x	Ionising radiation information	N/A
Kazakhstan	Standard documentation to be submitted	EMEA	34	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Kazakhstan	Patients' involvement	EMEA	34	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Kazakhstan	Patients' involvement	EMEA	34	4a	Brief description of the type and extent of patients’ involvement	N/A
Kazakhstan	Patients' involvement	EMEA	34	4b	Timing of patients’ involvement	N/A
Kazakhstan	HTA involvement	EMEA	34	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Kazakhstan	HTA involvement	EMEA	34	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Kazakhstan	HTA involvement	EMEA	34	5b	Timing of HTA bodies’ involvement	N/A
Kazakhstan	Expert involvement	EMEA	34	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Kazakhstan	Expert involvement	EMEA	34	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Kazakhstan	Expert involvement	EMEA	34	6b	Timing of expert panels’ involvement	N/A
Kazakhstan	Reimbursement	EMEA	34	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Kazakhstan	Reimbursement	EMEA	34	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Russia	General	EMEA	35	1	Link to the website of the procedure	https://docs.cntd.ru/document/1200110952
Russia	Fee	EMEA	35	2	Fee (€)	Depends on medical device, insurance, cost of the clinic, samples.
Russia	Standard documentation to be submitted	EMEA	35	3a	Cover letter	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3b	Authorisation/application form	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3c	Investigator's Brochure	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3f	Case Report Form (CRF)	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3g	Informed Consent Form (ICF)	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3h	Proof of insurance cover	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3j	Proof of payment of the fee	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3k	Opinion of experts’ panels	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3l	CE certificates of Notified Bodies	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3m	Decisions of other Competent Authorities concerned	Yes, optional
Russia	Standard documentation to be submitted	EMEA	35	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3o	Recruitment procedures and advertising materials	No
Russia	Standard documentation to be submitted	EMEA	35	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3q	General Device Information	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3r	Medicinal products contained in the device	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3s	List of participating countries	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3t	Trial centres list	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3v	Compliance to ISO 14155	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3w	MRI checklist	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3x	Ionising radiation information	Yes, mandatory
Russia	Standard documentation to be submitted	EMEA	35	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Russia	Patients' involvement	EMEA	35	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Russia	Patients' involvement	EMEA	35	4a	Brief description of the type and extent of patients’ involvement	N/A
Russia	Patients' involvement	EMEA	35	4b	Timing of patients’ involvement	N/A
Russia	HTA involvement	EMEA	35	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Russia	HTA involvement	EMEA	35	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Russia	HTA involvement	EMEA	35	5b	Timing of HTA bodies’ involvement	N/A
Russia	Expert involvement	EMEA	35	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Russia	Expert involvement	EMEA	35	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Russia	Expert involvement	EMEA	35	6b	Timing of expert panels’ involvement	N/A
Russia	Reimbursement	EMEA	35	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Russia	Reimbursement	EMEA	35	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Saudi Arabia	General	EMEA	36	1	Link to the website of the procedure	https://sfda.gov.sa/en/regulations/66129
Saudi Arabia	Fee	EMEA	36	2	Fee (€)	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3a	Cover letter	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3b	Authorisation/application form	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3c	Investigator's Brochure	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3f	Case Report Form (CRF)	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3g	Informed Consent Form (ICF)	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3h	Proof of insurance cover	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3j	Proof of payment of the fee	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3k	Opinion of experts’ panels	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3l	CE certificates of Notified Bodies	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3m	Decisions of other Competent Authorities concerned	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3o	Recruitment procedures and advertising materials	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3p	Opinion of other Ethics Committees concerned	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3q	General Device Information	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3r	Medicinal products contained in the device	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3s	List of participating countries	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3t	Trial centres list	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3u	Declaration of possession of requirements for trial centres	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3v	Compliance to ISO 14155	Yes, mandatory
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3w	MRI checklist	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3x	Ionising radiation information	N/A
Saudi Arabia	Standard documentation to be submitted	EMEA	36	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Saudi Arabia	Patients' involvement	EMEA	36	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Saudi Arabia	Patients' involvement	EMEA	36	4a	Brief description of the type and extent of patients’ involvement	N/A
Saudi Arabia	Patients' involvement	EMEA	36	4b	Timing of patients’ involvement	N/A
Saudi Arabia	HTA involvement	EMEA	36	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Saudi Arabia	HTA involvement	EMEA	36	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Saudi Arabia	HTA involvement	EMEA	36	5b	Timing of HTA bodies’ involvement	N/A
Saudi Arabia	Expert involvement	EMEA	36	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Saudi Arabia	Expert involvement	EMEA	36	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Saudi Arabia	Expert involvement	EMEA	36	6b	Timing of expert panels’ involvement	N/A
Saudi Arabia	Reimbursement	EMEA	36	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Saudi Arabia	Reimbursement	EMEA	36	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
South Africa	Fee	EMEA	37	1	Fee (€)	816
South Africa	Standard documentation to be submitted	EMEA	37	3	Standard documentation to be submitted:	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3a	Cover letter	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3b	Authorisation/application form	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3c	Investigator's Brochure	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3e	Copy of the opinion of the ethics committee	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3f	Case Report Form (CRF)	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3g	Informed Consent Form (ICF)	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3h	Proof of insurance cover	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3j	Proof of payment of the fee	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3k	Opinion of experts’ panels	Yes, optional
South Africa	Standard documentation to be submitted	EMEA	37	3l	CE certificates of Notified Bodies	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3m	Decisions of other Competent Authorities concerned	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3o	Recruitment procedures and advertising materials	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3p	Opinion of other Ethics Committees concerned	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3q	General Device Information	Yes, mandatory
South Africa	Standard documentation to be submitted	EMEA	37	3r	Medicinal products contained in the device	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3s	List of participating countries	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3t	Trial centres list	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3u	Declaration of possession of requirements for trial centres	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3v	Compliance to ISO 14155	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3w	MRI checklist	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3x	Ionising radiation information	N/A
South Africa	Standard documentation to be submitted	EMEA	37	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
South Africa	Patients' involvement	EMEA	37	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
South Africa	Patients' involvement	EMEA	37	4a	Brief description of the type and extent of patients’ involvement	N/A
South Africa	Patients' involvement	EMEA	37	4b	Timing of patients’ involvement	N/A
South Africa	HTA involvement	EMEA	37	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
South Africa	HTA involvement	EMEA	37	5a	Brief description of the type and extent of HTA bodies involvement	N/A
South Africa	HTA involvement	EMEA	37	5b	Timing of HTA bodies’ involvement	N/A
South Africa	Expert involvement	EMEA	37	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
South Africa	Expert involvement	EMEA	37	6a	Brief description of the type and extent of expert panels’ involvement	N/A
South Africa	Expert involvement	EMEA	37	6b	Timing of expert panels’ involvement	N/A
South Africa	Reimbursement	EMEA	37	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
South Africa	Reimbursement	EMEA	37	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Switzerland	General	EMEA	38	1	Link to the website of the procedure	https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/klinische-pruefungen.html
Switzerland	Fee	EMEA	38	2	Fee (€)	5311
Switzerland	Standard documentation to be submitted	EMEA	38	3a	Cover letter	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3b	Authorisation/application form	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3c	Investigator's Brochure	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3e	Copy of the opinion of the ethics committee	Yes, optional
Switzerland	Standard documentation to be submitted	EMEA	38	3f	Case Report Form (CRF)	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3g	Informed Consent Form (ICF)	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3h	Proof of insurance cover	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Switzerland	Standard documentation to be submitted	EMEA	38	3j	Proof of payment of the fee	N/A
Switzerland	Standard documentation to be submitted	EMEA	38	3k	Opinion of experts’ panels	No
Switzerland	Standard documentation to be submitted	EMEA	38	3l	CE certificates of Notified Bodies	Yes, optional
Switzerland	Standard documentation to be submitted	EMEA	38	3m	Decisions of other Competent Authorities concerned	Yes, optional
Switzerland	Standard documentation to be submitted	EMEA	38	3n	Post Market Clinical Follow-up (PMCF) plan	No
Switzerland	Standard documentation to be submitted	EMEA	38	3o	Recruitment procedures and advertising materials	No
Switzerland	Standard documentation to be submitted	EMEA	38	3p	Opinion of other Ethics Committees concerned	Yes, optional
Switzerland	Standard documentation to be submitted	EMEA	38	3q	General Device Information	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3r	Medicinal products contained in the device	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3s	List of participating countries	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3t	Trial centres list	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3u	Declaration of possession of requirements for trial centres	No
Switzerland	Standard documentation to be submitted	EMEA	38	3v	Compliance to ISO 14155	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3w	MRI checklist	No
Switzerland	Standard documentation to be submitted	EMEA	38	3x	Ionising radiation information	Yes, mandatory
Switzerland	Standard documentation to be submitted	EMEA	38	3y	Serious Adverse Event (SAE) Report Form	No
Switzerland	Patients' involvement	EMEA	38	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Switzerland	Patients' involvement	EMEA	38	4a	Brief description of the type and extent of patients’ involvement	N/A
Switzerland	Patients' involvement	EMEA	38	4b	Timing of patients’ involvement	N/A
Switzerland	HTA involvement	EMEA	38	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Switzerland	HTA involvement	EMEA	38	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Switzerland	HTA involvement	EMEA	38	5b	Timing of HTA bodies’ involvement	N/A
Switzerland	Expert involvement	EMEA	38	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Switzerland	Expert involvement	EMEA	38	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Switzerland	Expert involvement	EMEA	38	6b	Timing of expert panels’ involvement	N/A
Switzerland	Reimbursement	EMEA	38	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Switzerland	Reimbursement	EMEA	38	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Tunisia	General	EMEA	39	1	Link to the website of the procedure	N/A
Tunisia	Fee	EMEA	39	2	Fee (€)	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3a	Cover letter	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3b	Authorisation/application form	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3c	Investigator's Brochure	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3d	Clinical Investigation Plan (CIP)	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3e	Copy of the opinion of the ethics committee	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3f	Case Report Form (CRF)	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3g	Informed Consent Form (ICF)	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3h	Proof of insurance cover	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3j	Proof of payment of the fee	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3k	Opinion of experts’ panels	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3l	CE certificates of Notified Bodies	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3m	Decisions of other Competent Authorities concerned	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3o	Recruitment procedures and advertising materials	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3p	Opinion of other Ethics Committees concerned	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3q	General Device Information	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3r	Medicinal products contained in the device	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3s	List of participating countries	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3t	Trial centres list	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3u	Declaration of possession of requirements for trial centres	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3v	Compliance to ISO 14155	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3w	MRI checklist	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3x	Ionising radiation information	N/A
Tunisia	Standard documentation to be submitted	EMEA	39	3y	Serious Adverse Event (SAE) Report Form	N/A
Tunisia	Patients' involvement	EMEA	39	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Tunisia	Patients' involvement	EMEA	39	4a	Brief description of the type and extent of patients’ involvement	N/A
Tunisia	Patients' involvement	EMEA	39	4b	Timing of patients’ involvement	N/A
Tunisia	HTA involvement	EMEA	39	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Tunisia	HTA involvement	EMEA	39	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Tunisia	HTA involvement	EMEA	39	5b	Timing of HTA bodies’ involvement	N/A
Tunisia	Expert involvement	EMEA	39	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Tunisia	Expert involvement	EMEA	39	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Tunisia	Expert involvement	EMEA	39	6b	Timing of expert panels’ involvement	N/A
Tunisia	Reimbursement	EMEA	39	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Tunisia	Reimbursement	EMEA	39	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Turkey	Fee	EMEA	40	1	Fee (€)	931
Turkey	Standard documentation to be submitted	EMEA	40	3	Standard documentation to be submitted:	N/A
Turkey	Standard documentation to be submitted	EMEA	40	3a	Cover letter	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3b	Authorisation/application form	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3c	Investigator's Brochure	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3f	Case Report Form (CRF)	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3g	Informed Consent Form (ICF)	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3h	Proof of insurance cover	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3j	Proof of payment of the fee	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3k	Opinion of experts’ panels	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3l	CE certificates of Notified Bodies	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3m	Decisions of other Competent Authorities concerned	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3o	Recruitment procedures and advertising materials	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3p	Opinion of other Ethics Committees concerned	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3q	General Device Information	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3r	Medicinal products contained in the device	No
Turkey	Standard documentation to be submitted	EMEA	40	3s	List of participating countries	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3t	Trial centres list	Yes, mandatory
Turkey	Standard documentation to be submitted	EMEA	40	3u	Declaration of possession of requirements for trial centres	No
Turkey	Standard documentation to be submitted	EMEA	40	3v	Compliance to ISO 14155	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3w	MRI checklist	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3x	Ionising radiation information	Yes, optional
Turkey	Standard documentation to be submitted	EMEA	40	3y	Serious Adverse Event (SAE) Report Form	Yes, optional
Turkey	Patients' involvement	EMEA	40	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Turkey	Patients' involvement	EMEA	40	4a	Brief description of the type and extent of patients’ involvement	N/A
Turkey	Patients' involvement	EMEA	40	4b	Timing of patients’ involvement	N/A
Turkey	HTA involvement	EMEA	40	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Turkey	HTA involvement	EMEA	40	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Turkey	HTA involvement	EMEA	40	5b	Timing of HTA bodies’ involvement	N/A
Turkey	Expert involvement	EMEA	40	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Turkey	Expert involvement	EMEA	40	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Turkey	Expert involvement	EMEA	40	6b	Timing of expert panels’ involvement	N/A
Turkey	Reimbursement	EMEA	40	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Turkey	Reimbursement	EMEA	40	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
UK	General	EMEA	41	1	Link to the website of the procedure	https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#overview
UK	Fee	EMEA	41	2	Fee (€)	I/IIa/IIb 8742 (resubmission 6677) IIb/invasive III 18284 (resubmission 12951)
UK	Standard documentation to be submitted	EMEA	41	3a	Cover letter	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3b	Authorisation/application form	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3c	Investigator's Brochure	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3e	Copy of the opinion of the ethics committee	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3f	Case Report Form (CRF)	N/A
UK	Standard documentation to be submitted	EMEA	41	3g	Informed Consent Form (ICF)	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3h	Proof of insurance cover	N/A
UK	Standard documentation to be submitted	EMEA	41	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
UK	Standard documentation to be submitted	EMEA	41	3j	Proof of payment of the fee	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3k	Opinion of experts’ panels	No
UK	Standard documentation to be submitted	EMEA	41	3l	CE certificates of Notified Bodies	Yes, optional
UK	Standard documentation to be submitted	EMEA	41	3m	Decisions of other Competent Authorities concerned	N/A
UK	Standard documentation to be submitted	EMEA	41	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
UK	Standard documentation to be submitted	EMEA	41	3o	Recruitment procedures and advertising materials	N/A
UK	Standard documentation to be submitted	EMEA	41	3p	Opinion of other Ethics Committees concerned	N/A
UK	Standard documentation to be submitted	EMEA	41	3q	General Device Information	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3r	Medicinal products contained in the device	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3s	List of participating countries	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3t	Trial centres list	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3u	Declaration of possession of requirements for trial centres	N/A
UK	Standard documentation to be submitted	EMEA	41	3v	Compliance to ISO 14155	Yes, mandatory
UK	Standard documentation to be submitted	EMEA	41	3w	MRI checklist	Yes, optional
UK	Standard documentation to be submitted	EMEA	41	3x	Ionising radiation information	Yes, optional
UK	Standard documentation to be submitted	EMEA	41	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
UK	Patients' involvement	EMEA	41	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
UK	Patients' involvement	EMEA	41	4a	Brief description of the type and extent of patients’ involvement	N/A
UK	Patients' involvement	EMEA	41	4b	Timing of patients’ involvement	N/A
UK	HTA involvement	EMEA	41	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
UK	HTA involvement	EMEA	41	5a	Brief description of the type and extent of HTA bodies involvement	N/A
UK	HTA involvement	EMEA	41	5b	Timing of HTA bodies’ involvement	N/A
UK	Expert involvement	EMEA	41	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
UK	Expert involvement	EMEA	41	6a	Brief description of the type and extent of expert panels’ involvement	N/A
UK	Expert involvement	EMEA	41	6b	Timing of expert panels’ involvement	N/A
UK	Reimbursement	EMEA	41	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
UK	Reimbursement	EMEA	41	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Canada	General	NAFTA	42	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
Canada	Fee	NAFTA	42	2	Fee (€)	No fee
Canada	Standard documentation to be submitted	NAFTA	42	3a	Cover letter	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3b	Authorisation/application form	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3c	Investigator's Brochure	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3f	Case Report Form (CRF)	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3g	Informed Consent Form (ICF)	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3h	Proof of insurance cover	No
Canada	Standard documentation to be submitted	NAFTA	42	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, optional
Canada	Standard documentation to be submitted	NAFTA	42	3j	Proof of payment of the fee	N/A
Canada	Standard documentation to be submitted	NAFTA	42	3k	Opinion of experts’ panels	N/A
Canada	Standard documentation to be submitted	NAFTA	42	3l	CE certificates of Notified Bodies	N/A
Canada	Standard documentation to be submitted	NAFTA	42	3m	Decisions of other Competent Authorities concerned	N/A
Canada	Standard documentation to be submitted	NAFTA	42	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Canada	Standard documentation to be submitted	NAFTA	42	3o	Recruitment procedures and advertising materials	No
Canada	Standard documentation to be submitted	NAFTA	42	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3q	General Device Information	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3r	Medicinal products contained in the device	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3s	List of participating countries	No
Canada	Standard documentation to be submitted	NAFTA	42	3t	Trial centres list	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Canada	Standard documentation to be submitted	NAFTA	42	3v	Compliance to ISO 14155	Yes, optional
Canada	Standard documentation to be submitted	NAFTA	42	3w	MRI checklist	Yes, optional
Canada	Standard documentation to be submitted	NAFTA	42	3x	Ionising radiation information	No
Canada	Standard documentation to be submitted	NAFTA	42	3y	Serious Adverse Event (SAE) Report Form	No
Canada	Patients' involvement	NAFTA	42	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Canada	Patients' involvement	NAFTA	42	4a	Brief description of the type and extent of patients’ involvement	N/A
Canada	Patients' involvement	NAFTA	42	4b	Timing of patients’ involvement	N/A
Canada	HTA involvement	NAFTA	42	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Canada	HTA involvement	NAFTA	42	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Canada	HTA involvement	NAFTA	42	5b	Timing of HTA bodies’ involvement	N/A
Canada	Expert involvement	NAFTA	42	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Canada	Expert involvement	NAFTA	42	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Canada	Expert involvement	NAFTA	42	6b	Timing of expert panels’ involvement	N/A
Canada	Reimbursement	NAFTA	42	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Canada	Reimbursement	NAFTA	42	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
USA	General	NAFTA	43	1	Link to the website of the procedure	https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program
USA	Fee	NAFTA	43	2	Fee (€)	No fee
USA	Standard documentation to be submitted	NAFTA	43	3a	Cover letter	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3b	Authorisation/application form	Yes, optional
USA	Standard documentation to be submitted	NAFTA	43	3c	Investigator's Brochure	N/A
USA	Standard documentation to be submitted	NAFTA	43	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3e	Copy of the opinion of the ethics committee	No
USA	Standard documentation to be submitted	NAFTA	43	3f	Case Report Form (CRF)	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3g	Informed Consent Form (ICF)	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3h	Proof of insurance cover	No
USA	Standard documentation to be submitted	NAFTA	43	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3j	Proof of payment of the fee	N/A
USA	Standard documentation to be submitted	NAFTA	43	3k	Opinion of experts’ panels	N/A
USA	Standard documentation to be submitted	NAFTA	43	3l	CE certificates of Notified Bodies	No
USA	Standard documentation to be submitted	NAFTA	43	3m	Decisions of other Competent Authorities concerned	No
USA	Standard documentation to be submitted	NAFTA	43	3n	Post Market Clinical Follow-up (PMCF) plan	No
USA	Standard documentation to be submitted	NAFTA	43	3o	Recruitment procedures and advertising materials	No
USA	Standard documentation to be submitted	NAFTA	43	3p	Opinion of other Ethics Committees concerned	No
USA	Standard documentation to be submitted	NAFTA	43	3q	General Device Information	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3r	Medicinal products contained in the device	Yes, mandatory
USA	Standard documentation to be submitted	NAFTA	43	3s	List of participating countries	No
USA	Standard documentation to be submitted	NAFTA	43	3t	Trial centres list	Yes, optional
USA	Standard documentation to be submitted	NAFTA	43	3u	Declaration of possession of requirements for trial centres	No
USA	Standard documentation to be submitted	NAFTA	43	3v	Compliance to ISO 14155	Yes, optional
USA	Standard documentation to be submitted	NAFTA	43	3w	MRI checklist	N/A
USA	Standard documentation to be submitted	NAFTA	43	3x	Ionising radiation information	No
USA	Standard documentation to be submitted	NAFTA	43	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
USA	Patients' involvement	NAFTA	43	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
USA	Patients' involvement	NAFTA	43	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.
USA	Patients' involvement	NAFTA	43	4b	Timing of patients’ involvement	Pre-submission, during review
USA	HTA involvement	NAFTA	43	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
USA	HTA involvement	NAFTA	43	5a	Brief description of the type and extent of HTA bodies involvement	N/A
USA	HTA involvement	NAFTA	43	5b	Timing of HTA bodies’ involvement	N/A
USA	Expert involvement	NAFTA	43	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
USA	Expert involvement	NAFTA	43	6a	Brief description of the type and extent of expert panels’ involvement	N/A
USA	Expert involvement	NAFTA	43	6b	Timing of expert panels’ involvement	N/A
USA	Reimbursement	NAFTA	43	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	Yes
USA	Reimbursement	NAFTA	43	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.
Argentina	General	LATAM	44	1	Link to the website of the procedure	https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-969-1997-42205/actualizacion
Argentina	Fee	LATAM	44	2	Fee (€)	No fee
Argentina	Standard documentation to be submitted	LATAM	44	3a	Cover letter	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3b	Authorisation/application form	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3c	Investigator's Brochure	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3f	Case Report Form (CRF)	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3g	Informed Consent Form (ICF)	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3h	Proof of insurance cover	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3j	Proof of payment of the fee	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3k	Opinion of experts’ panels	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3l	CE certificates of Notified Bodies	N/A
Argentina	Standard documentation to be submitted	LATAM	44	3m	Decisions of other Competent Authorities concerned	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3o	Recruitment procedures and advertising materials	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3q	General Device Information	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3r	Medicinal products contained in the device	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3s	List of participating countries	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3t	Trial centres list	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3v	Compliance to ISO 14155	No
Argentina	Standard documentation to be submitted	LATAM	44	3w	MRI checklist	No
Argentina	Standard documentation to be submitted	LATAM	44	3x	Ionising radiation information	Yes, mandatory
Argentina	Standard documentation to be submitted	LATAM	44	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Argentina	Patients' involvement	LATAM	44	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Argentina	Patients' involvement	LATAM	44	4a	Brief description of the type and extent of patients’ involvement	N/A
Argentina	Patients' involvement	LATAM	44	4b	Timing of patients’ involvement	N/A
Argentina	HTA involvement	LATAM	44	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Argentina	HTA involvement	LATAM	44	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Argentina	HTA involvement	LATAM	44	5b	Timing of HTA bodies’ involvement	N/A
Argentina	Expert involvement	LATAM	44	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Argentina	Expert involvement	LATAM	44	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Argentina	Expert involvement	LATAM	44	6b	Timing of expert panels’ involvement	N/A
Argentina	Reimbursement	LATAM	44	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Argentina	Reimbursement	LATAM	44	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Brazil	General	LATAM	45	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
Brazil	Fee	LATAM	45	2	Fee (€)	No fee
Brazil	Standard documentation to be submitted	LATAM	45	3a	Cover letter	N/A
Brazil	Standard documentation to be submitted	LATAM	45	3b	Authorisation/application form	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3c	Investigator's Brochure	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3f	Case Report Form (CRF)	No
Brazil	Standard documentation to be submitted	LATAM	45	3g	Informed Consent Form (ICF)	No
Brazil	Standard documentation to be submitted	LATAM	45	3h	Proof of insurance cover	No
Brazil	Standard documentation to be submitted	LATAM	45	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3j	Proof of payment of the fee	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3k	Opinion of experts’ panels	N/A
Brazil	Standard documentation to be submitted	LATAM	45	3l	CE certificates of Notified Bodies	N/A
Brazil	Standard documentation to be submitted	LATAM	45	3m	Decisions of other Competent Authorities concerned	No
Brazil	Standard documentation to be submitted	LATAM	45	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Brazil	Standard documentation to be submitted	LATAM	45	3o	Recruitment procedures and advertising materials	No
Brazil	Standard documentation to be submitted	LATAM	45	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3q	General Device Information	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3r	Medicinal products contained in the device	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3s	List of participating countries	No
Brazil	Standard documentation to be submitted	LATAM	45	3t	Trial centres list	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3v	Compliance to ISO 14155	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3w	MRI checklist	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3x	Ionising radiation information	Yes, mandatory
Brazil	Standard documentation to be submitted	LATAM	45	3y	Serious Adverse Event (SAE) Report Form	No
Brazil	Patients' involvement	LATAM	45	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Brazil	Patients' involvement	LATAM	45	4a	Brief description of the type and extent of patients’ involvement	N/A
Brazil	Patients' involvement	LATAM	45	4b	Timing of patients’ involvement	N/A
Brazil	HTA involvement	LATAM	45	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Brazil	HTA involvement	LATAM	45	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Brazil	HTA involvement	LATAM	45	5b	Timing of HTA bodies’ involvement	N/A
Brazil	Expert involvement	LATAM	45	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Brazil	Expert involvement	LATAM	45	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Brazil	Expert involvement	LATAM	45	6b	Timing of expert panels’ involvement	N/A
Brazil	Reimbursement	LATAM	45	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Brazil	Reimbursement	LATAM	45	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Chile	General	LATAM	46	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/
Chile	Fee	LATAM	46	2	Fee (€)	900-2700
Chile	Standard documentation to be submitted	LATAM	46	3a	Cover letter	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3b	Authorisation/application form	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3c	Investigator's Brochure	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3f	Case Report Form (CRF)	No
Chile	Standard documentation to be submitted	LATAM	46	3g	Informed Consent Form (ICF)	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3h	Proof of insurance cover	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Chile	Standard documentation to be submitted	LATAM	46	3j	Proof of payment of the fee	No
Chile	Standard documentation to be submitted	LATAM	46	3k	Opinion of experts’ panels	N/A
Chile	Standard documentation to be submitted	LATAM	46	3l	CE certificates of Notified Bodies	N/A
Chile	Standard documentation to be submitted	LATAM	46	3m	Decisions of other Competent Authorities concerned	No
Chile	Standard documentation to be submitted	LATAM	46	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Chile	Standard documentation to be submitted	LATAM	46	3o	Recruitment procedures and advertising materials	No
Chile	Standard documentation to be submitted	LATAM	46	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3q	General Device Information	No
Chile	Standard documentation to be submitted	LATAM	46	3r	Medicinal products contained in the device	No
Chile	Standard documentation to be submitted	LATAM	46	3s	List of participating countries	Yes, mandatory
Chile	Standard documentation to be submitted	LATAM	46	3t	Trial centres list	No
Chile	Standard documentation to be submitted	LATAM	46	3u	Declaration of possession of requirements for trial centres	No
Chile	Standard documentation to be submitted	LATAM	46	3v	Compliance to ISO 14155	No
Chile	Standard documentation to be submitted	LATAM	46	3w	MRI checklist	No
Chile	Standard documentation to be submitted	LATAM	46	3x	Ionising radiation information	No
Chile	Standard documentation to be submitted	LATAM	46	3y	Serious Adverse Event (SAE) Report Form	No
Chile	Patients' involvement	LATAM	46	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Chile	Patients' involvement	LATAM	46	4a	Brief description of the type and extent of patients’ involvement	N/A
Chile	Patients' involvement	LATAM	46	4b	Timing of patients’ involvement	N/A
Chile	HTA involvement	LATAM	46	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Chile	HTA involvement	LATAM	46	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Chile	HTA involvement	LATAM	46	5b	Timing of HTA bodies’ involvement	N/A
Chile	Expert involvement	LATAM	46	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Chile	Expert involvement	LATAM	46	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Chile	Expert involvement	LATAM	46	6b	Timing of expert panels’ involvement	N/A
Chile	Reimbursement	LATAM	46	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Chile	Reimbursement	LATAM	46	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Colombia	General	LATAM	47	1	Link to the website of the procedure	https://app.invima.gov.co/ovirtual/
Colombia	Fee	LATAM	47	2	Fee (€)	3341
Colombia	Standard documentation to be submitted	LATAM	47	3a	Cover letter	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3b	Authorisation/application form	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3c	Investigator's Brochure	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3d	Clinical Investigation Plan (CIP)	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3f	Case Report Form (CRF)	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3g	Informed Consent Form (ICF)	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3h	Proof of insurance cover	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3j	Proof of payment of the fee	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3k	Opinion of experts’ panels	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3l	CE certificates of Notified Bodies	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3m	Decisions of other Competent Authorities concerned	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3o	Recruitment procedures and advertising materials	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3q	General Device Information	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3r	Medicinal products contained in the device	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3s	List of participating countries	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3t	Trial centres list	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Colombia	Standard documentation to be submitted	LATAM	47	3v	Compliance to ISO 14155	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3w	MRI checklist	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3x	Ionising radiation information	N/A
Colombia	Standard documentation to be submitted	LATAM	47	3y	Serious Adverse Event (SAE) Report Form	N/A
Colombia	Patients' involvement	LATAM	47	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Colombia	Patients' involvement	LATAM	47	4a	Brief description of the type and extent of patients’ involvement	N/A
Colombia	Patients' involvement	LATAM	47	4b	Timing of patients’ involvement	N/A
Colombia	HTA involvement	LATAM	47	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Colombia	HTA involvement	LATAM	47	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Colombia	HTA involvement	LATAM	47	5b	Timing of HTA bodies’ involvement	N/A
Colombia	Expert involvement	LATAM	47	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Colombia	Expert involvement	LATAM	47	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Colombia	Expert involvement	LATAM	47	6b	Timing of expert panels’ involvement	N/A
Colombia	Reimbursement	LATAM	47	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Colombia	Reimbursement	LATAM	47	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Paraguay	General	LATAM	48	1	Link to the website of the procedure	https://dinavisa.gov.py/wp-content/uploads/2023/09/Requisitos-de-Ensayos-Clinicos.pdf
Paraguay	Fee	LATAM	48	2	Fee (€)	900-2700
Paraguay	Standard documentation to be submitted	LATAM	48	3a	Cover letter	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3b	Authorisation/application form	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3c	Investigator's Brochure	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3f	Case Report Form (CRF)	No
Paraguay	Standard documentation to be submitted	LATAM	48	3g	Informed Consent Form (ICF)	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3h	Proof of insurance cover	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Paraguay	Standard documentation to be submitted	LATAM	48	3j	Proof of payment of the fee	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3k	Opinion of experts’ panels	No
Paraguay	Standard documentation to be submitted	LATAM	48	3l	CE certificates of Notified Bodies	No
Paraguay	Standard documentation to be submitted	LATAM	48	3m	Decisions of other Competent Authorities concerned	No
Paraguay	Standard documentation to be submitted	LATAM	48	3n	Post Market Clinical Follow-up (PMCF) plan	No
Paraguay	Standard documentation to be submitted	LATAM	48	3o	Recruitment procedures and advertising materials	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3q	General Device Information	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3r	Medicinal products contained in the device	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3s	List of participating countries	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3t	Trial centres list	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3v	Compliance to ISO 14155	No
Paraguay	Standard documentation to be submitted	LATAM	48	3w	MRI checklist	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3x	Ionising radiation information	Yes, mandatory
Paraguay	Standard documentation to be submitted	LATAM	48	3y	Serious Adverse Event (SAE) Report Form	No
Paraguay	Patients' involvement	LATAM	48	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Paraguay	Patients' involvement	LATAM	48	4a	Brief description of the type and extent of patients’ involvement	N/A
Paraguay	Patients' involvement	LATAM	48	4b	Timing of patients’ involvement	N/A
Paraguay	HTA involvement	LATAM	48	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Paraguay	HTA involvement	LATAM	48	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Paraguay	HTA involvement	LATAM	48	5b	Timing of HTA bodies’ involvement	N/A
Paraguay	Expert involvement	LATAM	48	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Paraguay	Expert involvement	LATAM	48	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Paraguay	Expert involvement	LATAM	48	6b	Timing of expert panels’ involvement	N/A
Paraguay	Reimbursement	LATAM	48	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Paraguay	Reimbursement	LATAM	48	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Australia	General	APAC	49	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.
Australia	Fee	APAC	49	2	Fee (€)	12,875
Australia	Standard documentation to be submitted	APAC	49	3a	Cover letter	N/A
Australia	Standard documentation to be submitted	APAC	49	3b	Authorisation/application form	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3c	Investigator's Brochure	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3d	Clinical Investigation Plan (CIP)	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3e	Copy of the opinion of the ethics committee	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3f	Case Report Form (CRF)	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3g	Informed Consent Form (ICF)	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3h	Proof of insurance cover	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Australia	Standard documentation to be submitted	APAC	49	3j	Proof of payment of the fee	Yes, optional
Australia	Standard documentation to be submitted	APAC	49	3k	Opinion of experts’ panels	No
Australia	Standard documentation to be submitted	APAC	49	3l	CE certificates of Notified Bodies	No
Australia	Standard documentation to be submitted	APAC	49	3m	Decisions of other Competent Authorities concerned	No
Australia	Standard documentation to be submitted	APAC	49	3n	Post Market Clinical Follow-up (PMCF) plan	No
Australia	Standard documentation to be submitted	APAC	49	3o	Recruitment procedures and advertising materials	No
Australia	Standard documentation to be submitted	APAC	49	3p	Opinion of other Ethics Committees concerned	No
Australia	Standard documentation to be submitted	APAC	49	3q	General Device Information	Yes, mandatory
Australia	Standard documentation to be submitted	APAC	49	3r	Medicinal products contained in the device	Yes, mandatory
Australia	Standard documentation to be submitted	APAC	49	3s	List of participating countries	Yes, mandatory
Australia	Standard documentation to be submitted	APAC	49	3t	Trial centres list	Yes, mandatory
Australia	Standard documentation to be submitted	APAC	49	3u	Declaration of possession of requirements for trial centres	No
Australia	Standard documentation to be submitted	APAC	49	3v	Compliance to ISO 14155	Yes, mandatory
Australia	Standard documentation to be submitted	APAC	49	3w	MRI checklist	No
Australia	Standard documentation to be submitted	APAC	49	3x	Ionising radiation information	No
Australia	Standard documentation to be submitted	APAC	49	3y	Serious Adverse Event (SAE) Report Form	No
Australia	Patients' involvement	APAC	49	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Australia	Patients' involvement	APAC	49	4a	Brief description of the type and extent of patients’ involvement	N/A
Australia	Patients' involvement	APAC	49	4b	Timing of patients’ involvement	N/A
Australia	HTA involvement	APAC	49	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Australia	HTA involvement	APAC	49	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Australia	HTA involvement	APAC	49	5b	Timing of HTA bodies’ involvement	N/A
Australia	Expert involvement	APAC	49	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Australia	Expert involvement	APAC	49	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Australia	Expert involvement	APAC	49	6b	Timing of expert panels’ involvement	N/A
Australia	Reimbursement	APAC	49	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Australia	Reimbursement	APAC	49	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
China	Fee	APAC	50	1	Fee (€)	N/A
China	Standard documentation to be submitted	APAC	50	3	Standard documentation to be submitted:	N/A
China	Standard documentation to be submitted	APAC	50	3a	Cover letter	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3b	Authorisation/application form	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3c	Investigator's Brochure	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3e	Copy of the opinion of the ethics committee	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3f	Case Report Form (CRF)	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3g	Informed Consent Form (ICF)	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3h	Proof of insurance cover	N/A
China	Standard documentation to be submitted	APAC	50	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
China	Standard documentation to be submitted	APAC	50	3j	Proof of payment of the fee	N/A
China	Standard documentation to be submitted	APAC	50	3k	Opinion of experts’ panels	N/A
China	Standard documentation to be submitted	APAC	50	3l	CE certificates of Notified Bodies	N/A
China	Standard documentation to be submitted	APAC	50	3m	Decisions of other Competent Authorities concerned	N/A
China	Standard documentation to be submitted	APAC	50	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
China	Standard documentation to be submitted	APAC	50	3o	Recruitment procedures and advertising materials	N/A
China	Standard documentation to be submitted	APAC	50	3p	Opinion of other Ethics Committees concerned	N/A
China	Standard documentation to be submitted	APAC	50	3q	General Device Information	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3r	Medicinal products contained in the device	N/A
China	Standard documentation to be submitted	APAC	50	3s	List of participating countries	N/A
China	Standard documentation to be submitted	APAC	50	3t	Trial centres list	N/A
China	Standard documentation to be submitted	APAC	50	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	3v	Compliance to ISO 14155	N/A
China	Standard documentation to be submitted	APAC	50	3w	MRI checklist	N/A
China	Standard documentation to be submitted	APAC	50	3x	Ionising radiation information	N/A
China	Standard documentation to be submitted	APAC	50	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
China	Standard documentation to be submitted	APAC	50	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?
China	Patients' involvement	APAC	50	4a	Brief description of the type and extent of patients’ involvement	N/A
China	Patients' involvement	APAC	50	4b	Timing of patients’ involvement	N/A
China	HTA involvement	APAC	50	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
China	HTA involvement	APAC	50	5a	Brief description of the type and extent of HTA bodies involvement	N/A
China	HTA involvement	APAC	50	5b	Timing of HTA bodies’ involvement	N/A
China	Expert involvement	APAC	50	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
China	Expert involvement	APAC	50	6a	Brief description of the type and extent of expert panels’ involvement	N/A
China	Expert involvement	APAC	50	6b	Timing of expert panels’ involvement	N/A
China	Reimbursement	APAC	50	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
China	Reimbursement	APAC	50	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Japan	Fee	APAC	51	1	Fee (€)	No fee
Japan	Standard documentation to be submitted	APAC	51	3	Standard documentation to be submitted:	N/A
Japan	Standard documentation to be submitted	APAC	51	3a	Cover letter	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3b	Authorisation/application form	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3c	Investigator's Brochure	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3e	Copy of the opinion of the ethics committee	No
Japan	Standard documentation to be submitted	APAC	51	3f	Case Report Form (CRF)	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3g	Informed Consent Form (ICF)	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3h	Proof of insurance cover	Yes, optional
Japan	Standard documentation to be submitted	APAC	51	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	No
Japan	Standard documentation to be submitted	APAC	51	3j	Proof of payment of the fee	N/A
Japan	Standard documentation to be submitted	APAC	51	3k	Opinion of experts’ panels	N/A
Japan	Standard documentation to be submitted	APAC	51	3l	CE certificates of Notified Bodies	N/A
Japan	Standard documentation to be submitted	APAC	51	3m	Decisions of other Competent Authorities concerned	No
Japan	Standard documentation to be submitted	APAC	51	3n	Post Market Clinical Follow-up (PMCF) plan	No
Japan	Standard documentation to be submitted	APAC	51	3o	Recruitment procedures and advertising materials	No
Japan	Standard documentation to be submitted	APAC	51	3p	Opinion of other Ethics Committees concerned	No
Japan	Standard documentation to be submitted	APAC	51	3q	General Device Information	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3r	Medicinal products contained in the device	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3s	List of participating countries	Yes, optional
Japan	Standard documentation to be submitted	APAC	51	3t	Trial centres list	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
Japan	Standard documentation to be submitted	APAC	51	3v	Compliance to ISO 14155	Yes, optional
Japan	Standard documentation to be submitted	APAC	51	3w	MRI checklist	Yes, optional
Japan	Standard documentation to be submitted	APAC	51	3x	Ionising radiation information	No
Japan	Standard documentation to be submitted	APAC	51	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Japan	Patients' involvement	APAC	51	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	No
Japan	Patients' involvement	APAC	51	4a	Brief description of the type and extent of patients’ involvement	N/A
Japan	Patients' involvement	APAC	51	4b	Timing of patients’ involvement	N/A
Japan	HTA involvement	APAC	51	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	No
Japan	HTA involvement	APAC	51	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Japan	HTA involvement	APAC	51	5b	Timing of HTA bodies’ involvement	N/A
Japan	Expert involvement	APAC	51	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	No
Japan	Expert involvement	APAC	51	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Japan	Expert involvement	APAC	51	6b	Timing of expert panels’ involvement	N/A
Japan	Reimbursement	APAC	51	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	No
Japan	Reimbursement	APAC	51	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
India	Fee	APAC	52	1	Fee (€)	Feasibility study 275 Pivotal study 1100
India	Standard documentation to be submitted	APAC	52	3	Standard documentation to be submitted:	N/A
India	Standard documentation to be submitted	APAC	52	3a	Cover letter	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3b	Authorisation/application form	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3c	Investigator's Brochure	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3e	Copy of the opinion of the ethics committee	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3f	Case Report Form (CRF)	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3g	Informed Consent Form (ICF)	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3h	Proof of insurance cover	No
India	Standard documentation to be submitted	APAC	52	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3j	Proof of payment of the fee	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3k	Opinion of experts’ panels	N/A
India	Standard documentation to be submitted	APAC	52	3l	CE certificates of Notified Bodies	N/A
India	Standard documentation to be submitted	APAC	52	3m	Decisions of other Competent Authorities concerned	N/A
India	Standard documentation to be submitted	APAC	52	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
India	Standard documentation to be submitted	APAC	52	3o	Recruitment procedures and advertising materials	N/A
India	Standard documentation to be submitted	APAC	52	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3q	General Device Information	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3r	Medicinal products contained in the device	Yes, optional
India	Standard documentation to be submitted	APAC	52	3s	List of participating countries	No
India	Standard documentation to be submitted	APAC	52	3t	Trial centres list	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3u	Declaration of possession of requirements for trial centres	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3v	Compliance to ISO 14155	Yes, mandatory
India	Standard documentation to be submitted	APAC	52	3w	MRI checklist	N/A
India	Standard documentation to be submitted	APAC	52	3x	Ionising radiation information	N/A
India	Standard documentation to be submitted	APAC	52	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
India	Patients' involvement	APAC	52	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
India	Patients' involvement	APAC	52	4a	Brief description of the type and extent of patients’ involvement	N/A
India	Patients' involvement	APAC	52	4b	Timing of patients’ involvement	N/A
India	HTA involvement	APAC	52	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
India	HTA involvement	APAC	52	5a	Brief description of the type and extent of HTA bodies involvement	N/A
India	HTA involvement	APAC	52	5b	Timing of HTA bodies’ involvement	N/A
India	Expert involvement	APAC	52	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
India	Expert involvement	APAC	52	6a	Brief description of the type and extent of expert panels’ involvement	N/A
India	Expert involvement	APAC	52	6b	Timing of expert panels’ involvement	N/A
India	Reimbursement	APAC	52	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
India	Reimbursement	APAC	52	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
New_Zealand	Fee	APAC	53	1	Fee (€)	No fee
New_Zealand	Standard documentation to be submitted	APAC	53	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.
New_Zealand	Standard documentation to be submitted	APAC	53	3a	Cover letter	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3b	Authorisation/application form	Yes, mandatory
New_Zealand	Standard documentation to be submitted	APAC	53	3c	Investigator's Brochure	Yes, mandatory
New_Zealand	Standard documentation to be submitted	APAC	53	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
New_Zealand	Standard documentation to be submitted	APAC	53	3e	Copy of the opinion of the ethics committee	Yes, mandatory
New_Zealand	Standard documentation to be submitted	APAC	53	3f	Case Report Form (CRF)	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3g	Informed Consent Form (ICF)	Yes, mandatory
New_Zealand	Standard documentation to be submitted	APAC	53	3h	Proof of insurance cover	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3j	Proof of payment of the fee	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3k	Opinion of experts’ panels	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3l	CE certificates of Notified Bodies	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3m	Decisions of other Competent Authorities concerned	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3o	Recruitment procedures and advertising materials	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3p	Opinion of other Ethics Committees concerned	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3q	General Device Information	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3r	Medicinal products contained in the device	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3s	List of participating countries	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3t	Trial centres list	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3u	Declaration of possession of requirements for trial centres	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3v	Compliance to ISO 14155	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3w	MRI checklist	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3x	Ionising radiation information	N/A
New_Zealand	Standard documentation to be submitted	APAC	53	3y	Serious Adverse Event (SAE) Report Form	N/A
New_Zealand	Patients' involvement	APAC	53	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
New_Zealand	Patients' involvement	APAC	53	4a	Brief description of the type and extent of patients’ involvement	N/A
New_Zealand	Patients' involvement	APAC	53	4b	Timing of patients’ involvement	N/A
New_Zealand	HTA involvement	APAC	53	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
New_Zealand	HTA involvement	APAC	53	5a	Brief description of the type and extent of HTA bodies involvement	N/A
New_Zealand	HTA involvement	APAC	53	5b	Timing of HTA bodies’ involvement	N/A
New_Zealand	Expert involvement	APAC	53	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
New_Zealand	Expert involvement	APAC	53	6a	Brief description of the type and extent of expert panels’ involvement	N/A
New_Zealand	Expert involvement	APAC	53	6b	Timing of expert panels’ involvement	N/A
New_Zealand	Reimbursement	APAC	53	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
New_Zealand	Reimbursement	APAC	53	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Republic_of_Korea	Fee	APAC	54	1	Fee (€)	No fee
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3	Standard documentation to be submitted:	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3a	Cover letter	No
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3b	Authorisation/application form	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3c	Investigator's Brochure	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3e	Copy of the opinion of the ethics committee	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3f	Case Report Form (CRF)	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3g	Informed Consent Form (ICF)	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3h	Proof of insurance cover	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3j	Proof of payment of the fee	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3k	Opinion of experts’ panels	Yes, optional
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3l	CE certificates of Notified Bodies	No
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3m	Decisions of other Competent Authorities concerned	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3n	Post Market Clinical Follow-up (PMCF) plan	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3o	Recruitment procedures and advertising materials	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3p	Opinion of other Ethics Committees concerned	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3q	General Device Information	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3r	Medicinal products contained in the device	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3s	List of participating countries	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3t	Trial centres list	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3u	Declaration of possession of requirements for trial centres	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3v	Compliance to ISO 14155	Yes, mandatory
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3w	MRI checklist	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3x	Ionising radiation information	N/A
Republic_of_Korea	Standard documentation to be submitted	APAC	54	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Republic_of_Korea	Patients' involvement	APAC	54	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Republic_of_Korea	Patients' involvement	APAC	54	4a	Brief description of the type and extent of patients’ involvement	N/A
Republic_of_Korea	Patients' involvement	APAC	54	4b	Timing of patients’ involvement	N/A
Republic_of_Korea	HTA involvement	APAC	54	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Republic_of_Korea	HTA involvement	APAC	54	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Republic_of_Korea	HTA involvement	APAC	54	5b	Timing of HTA bodies’ involvement	N/A
Republic_of_Korea	Expert involvement	APAC	54	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Republic_of_Korea	Expert involvement	APAC	54	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Republic_of_Korea	Expert involvement	APAC	54	6b	Timing of expert panels’ involvement	N/A
Republic_of_Korea	Reimbursement	APAC	54	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Republic_of_Korea	Reimbursement	APAC	54	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Taiwan	Fee	APAC	55	1	Fee (€)	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3	Standard documentation to be submitted:	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3a	Cover letter	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3b	Authorisation/application form	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3c	Investigator's Brochure	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3e	Copy of the opinion of the ethics committee	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3f	Case Report Form (CRF)	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3g	Informed Consent Form (ICF)	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3h	Proof of insurance cover	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	Yes, mandatory
Taiwan	Standard documentation to be submitted	APAC	55	3j	Proof of payment of the fee	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3k	Opinion of experts’ panels	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3l	CE certificates of Notified Bodies	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3m	Decisions of other Competent Authorities concerned	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3o	Recruitment procedures and advertising materials	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3p	Opinion of other Ethics Committees concerned	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3q	General Device Information	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3r	Medicinal products contained in the device	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3s	List of participating countries	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3t	Trial centres list	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3u	Declaration of possession of requirements for trial centres	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3v	Compliance to ISO 14155	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3w	MRI checklist	N/A
Taiwan	Standard documentation to be submitted	APAC	55	3x	Ionising radiation information	Yes, optional
Taiwan	Standard documentation to be submitted	APAC	55	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Taiwan	Patients' involvement	APAC	55	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Taiwan	Patients' involvement	APAC	55	4a	Brief description of the type and extent of patients’ involvement	N/A
Taiwan	Patients' involvement	APAC	55	4b	Timing of patients’ involvement	N/A
Taiwan	HTA involvement	APAC	55	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Taiwan	HTA involvement	APAC	55	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Taiwan	HTA involvement	APAC	55	5b	Timing of HTA bodies’ involvement	N/A
Taiwan	Expert involvement	APAC	55	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Taiwan	Expert involvement	APAC	55	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Taiwan	Expert involvement	APAC	55	6b	Timing of expert panels’ involvement	N/A
Taiwan	Reimbursement	APAC	55	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Taiwan	Reimbursement	APAC	55	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Singapore	Fee	APAC	56	1	Fee (€)	N/A
Singapore	Standard documentation to be submitted	APAC	56	3	Standard documentation to be submitted:	N/A
Singapore	Standard documentation to be submitted	APAC	56	3a	Cover letter	Yes, mandatory
Singapore	Standard documentation to be submitted	APAC	56	3b	Authorisation/application form	Yes, mandatory
Singapore	Standard documentation to be submitted	APAC	56	3c	Investigator's Brochure	Yes, mandatory
Singapore	Standard documentation to be submitted	APAC	56	3d	Clinical Investigation Plan (CIP)	Yes, mandatory
Singapore	Standard documentation to be submitted	APAC	56	3e	Copy of the opinion of the ethics committee	N/A
Singapore	Standard documentation to be submitted	APAC	56	3f	Case Report Form (CRF)	N/A
Singapore	Standard documentation to be submitted	APAC	56	3g	Informed Consent Form (ICF)	N/A
Singapore	Standard documentation to be submitted	APAC	56	3h	Proof of insurance cover	N/A
Singapore	Standard documentation to be submitted	APAC	56	3i	Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information	N/A
Singapore	Standard documentation to be submitted	APAC	56	3j	Proof of payment of the fee	N/A
Singapore	Standard documentation to be submitted	APAC	56	3k	Opinion of experts’ panels	N/A
Singapore	Standard documentation to be submitted	APAC	56	3l	CE certificates of Notified Bodies	N/A
Singapore	Standard documentation to be submitted	APAC	56	3m	Decisions of other Competent Authorities concerned	N/A
Singapore	Standard documentation to be submitted	APAC	56	3n	Post Market Clinical Follow-up (PMCF) plan	N/A
Singapore	Standard documentation to be submitted	APAC	56	3o	Recruitment procedures and advertising materials	N/A
Singapore	Standard documentation to be submitted	APAC	56	3p	Opinion of other Ethics Committees concerned	N/A
Singapore	Standard documentation to be submitted	APAC	56	3q	General Device Information	N/A
Singapore	Standard documentation to be submitted	APAC	56	3r	Medicinal products contained in the device	N/A
Singapore	Standard documentation to be submitted	APAC	56	3s	List of participating countries	N/A
Singapore	Standard documentation to be submitted	APAC	56	3t	Trial centres list	N/A
Singapore	Standard documentation to be submitted	APAC	56	3u	Declaration of possession of requirements for trial centres	N/A
Singapore	Standard documentation to be submitted	APAC	56	3v	Compliance to ISO 14155	N/A
Singapore	Standard documentation to be submitted	APAC	56	3w	MRI checklist	N/A
Singapore	Standard documentation to be submitted	APAC	56	3x	Ionising radiation information	N/A
Singapore	Standard documentation to be submitted	APAC	56	3y	Serious Adverse Event (SAE) Report Form	Yes, mandatory
Singapore	Patients' involvement	APAC	56	4	Does the procedure require patients' involvement in the design of pre-market clinical investigations for MDs?	N/A
Singapore	Patients' involvement	APAC	56	4a	Brief description of the type and extent of patients’ involvement	N/A
Singapore	Patients' involvement	APAC	56	4b	Timing of patients’ involvement	N/A
Singapore	HTA involvement	APAC	56	5	Does the procedure require HTA bodies' involvement in the design of pre-market clinical investigations for MDs?	N/A
Singapore	HTA involvement	APAC	56	5a	Brief description of the type and extent of HTA bodies involvement	N/A
Singapore	HTA involvement	APAC	56	5b	Timing of HTA bodies’ involvement	N/A
Singapore	Expert involvement	APAC	56	6	Does the procedure require expert panels' involvement in the design of pre-market clinical investigations for MDs?	N/A
Singapore	Expert involvement	APAC	56	6a	Brief description of the type and extent of expert panels’ involvement	N/A
Singapore	Expert involvement	APAC	56	6b	Timing of expert panels’ involvement	N/A
Singapore	Reimbursement	APAC	56	7	Does the procedure include the possibility to reimburse investigational devices in pre-market clinical investigations?	N/A
Singapore	Reimbursement	APAC	56	7a	Brief description of criteria in place for reimbursement of investigational devices in pre-market clinical investigations	N/A
Country		Jurisdiction			Topic