Fimea may grant a temporary derogation for the placing on the market or putting into service of a medical device even if the conformity assessment procedure for the device has not been carried out in accordance with the legislation currently in force if:
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 clearly describes the need for a derogation, should also be included.