CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)

CA - Submission for authorisation mandatory for

MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP

CE-marked MD used within label are exempted from any notification obligation to CA

Yes

National trial registry

Central Register of Clinical Research (CEBK), but not available for the public.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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