Application for an exemption for placing a medical device on the market or putting one into service

The applicants are advised to contact Fimea via email derogations@fimea.fi already when preparing the application.

The derogation is applied for by using Fimeas application form or with a free-form application which includes detailed information about the device, manufacturer, and information based on which the provisions concerning the granting of derogation are filled. A cover letter, which cl ...