The clinical investigation of class III medical devices and of devices that are implantable or invasive for the long-term as in class IIa and IIb must be notified at least 60 days before the beginning of the investigation. The investigation can start 60 days after notification unless a negative opinion has been given by the competent authority and as long as the ethical committee concerned has given a favourable opinion. Should there be no objection, authorisation to start the study before the 60 day term can be given.
Investigations conducted with devices that do not belong to the classes mentioned above do not require a 60 day waiting period.
Federal Agency for Medicines and Health Products
Place Victor Horta, 40 box 40
Email : firstname.lastname@example.org