CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
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

CA - Submission required to

National CA
(MHRA)

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

Yes

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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