These clinical studies will be jointly reviewed by the FAMHP and an independent ethics committee, accredited through the law of 07/05/2017. Only one submission is required through the national contact (FAMHP) and only one joint opinion will be delivered. The complete file must be submitted, via the CESP, to the FAMHP.
These studies can therefore not be submitted directly to EC Research.
The following types of studies should be submitted according to this pathway:
➔ clinical study with CE-marked device used outside the intended purpose
➔ clinical study with device without CE marking that is not an in-house or custom-made medical device
➔ clinical study with custom-made medical device with conformity assessment purpose