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 5 ...
The certificate of free sale can be requested by a domestic manufacturer and an authorised representative who have registered their devices with Fimea for the Eudamed or the CERE register. The certificate of free sale is issued separately for devices in conformity with the Regulation and the Directive, as well as for the company’s different trade names and potential auxiliary trade names.
The same certificate of free sale may not contain:
A request for a certificate of free sale shall be sent to Fimea by e-mail at: laiterekisteri@fimea.fi.
If the information in the request is incorrect, the applicant may be required to supplement their request for a certificate of free sale. Fimea will send the signed and stamped certificate of free sale by post.
The certificate of free sale is issued in English.
The certificate of free sale can be requested by a domestic manufacturer and an authorised representative who have registered their devices with Fimea for the Eudamed or the CERE register.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC