CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
Agency for data protection
Other (e.g. in case of radiation)

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

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


Additional Information

For MD combined with IMP considered as ancillary, in addition to the MD notification to the CA a scientific advice will be required by a medicine Agency (FAGG, EMEA or other).

Submission to CA and EC to be performed in the following order

In parallel
Sequentially (in any order)
Note: For an investigation with a medical device, the FAMHP will not deliver its approval before having received the written LEC approval