Certificate of free sale
For devices marketed in third countries, the buyer country often requires an official certificate stating that there are no obstacles for their export. Upon request, Fimea issues certificates of free sale for medical devices that have been notified to Fimea in the CERE register or to Eudamed. Provisions on the certificate of free sale are laid down in Article 60 of Regulation 2017/745 or Article 55 of Regulation 2017/746.
Where necessary, Fimea will issue registration certificates for medical devices notified to Fimea. Registration certificates are requested in accordance with the procedure instructed for a certificate of free sale.
Requests for certificates of free sale and registration certificates are to be sent to: [email protected].