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Open Call For Pilots
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Databases
Access Full Table [ General information ]
Access Full Table [ Detailed information on application procedures ]
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Cross-country comparison of application requirements
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Cover letter
Authorisation/application form
Clinical Investigation Plan (CIP)
Copy of the opinion of the Ethics Committee
Case Report Form (CRF)
Informed Consent Form (ICF)
Proof of insurance cover
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data/information
Proof of payment of the fee
Opinion of experts’ panels
CE certificates of Notified Bodies
Decisions of other National Competent Authorities concerned
Post Market Clinical Follow-up (PMCF) plan
Opinion of other Ethics Committees concerned
General Device Information
Medicinal products contained in the device
List of participating countries
Declaration of possession of requirements for trial centres
Compliance to ISO 14155
MRI checklist
Ionising radiation information
Serious Adverse Event (SAE) Report Form
HEUEFS
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