Medical devices illustration

Clinical investigation

Clinical investigation

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.

Clinical investigation application/notification documents: MDCG 2021-08.
Q&A: MDCG 2021-6.
Will be soon updated with additional information in English.
Visit kliininen arviointi ja tutkimus (in Finnish).

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)