These clinical studies are reviewed separately by the FAMHP and the ethics committee(s). Two parallel submissions are required:
- Submission and approval of the file directly to the EC(s).
- Submission (and approval) of the file to the FAMHP. The file needs to be submitted electronically via CESP.
The following types of studies need to be submitted according to this pathway:
➔ Clinical study with in-house medical device
➔ Clinical study with customised medical device without conformity assessment purpose