Clinical investigations are used to determine the functioning and suitability for use of medical devices, as necessary. Such investigations assess the features, performance and adverse effects of medical devices and constitute part of the procedure to demonstrate conformity prior to placing on the market or putting into service.
The requirements concerning clinical investigations are contained in national legislation. Standards SFS-EN ISO 14155-1 and SFS-EN ISO 14155-2 may be used as an aid in the design and implementation of clinical investigations.
Fimea shall be notified at the beginning of the clinical investigation by using the form “Notification of a clinical investigation of medical devices”.
The processing fee charged for a clinical investigation notification is
- € 700 for products in category A (non-risk products)
- € 1 750 for products in category B (risk products)