A manufacturer, or his legal representative, must notify the Research and Development (human use) department of the FAMHP of any study intended to test the performance of an in vitro diagnostic medical device (IVD) in medical laboratories or in any other suitable environment outside its own premises.
Such performance studies in the context of IVDs must be notified at the latest when the medical device is made available.
The manufacturer concerned must submit the notification file to the FAMHP. This can be done electronically in accordance with the established procedure via the Common European Submission Platform (CESP). The file must contain the following elements:
- The properly filled out notification form
- The Clinical Investigational Plan (CIP) or protocol containing the objective, the scientific, technical or medical motivation, the applied methodology, the scope of the study and the number of IVDs concerned.
Within fourteen working days of receipt of the notification file, the Research and Development (human use) department of the FAMHP sends a confirmation of receipt with the national reference of the file (IVDPSxxxxxx) to the manufacturer.
A fee is payable for the notification of performance studies and after the submission of a performance study an invoice will be sent to the applicant. The amount is stated on the FAMHP website (French version). Attention, this is a new payment method where the invoice replaces the advanced payment. advanced payment.