Responsible for the service Finnish Medicines Agency Fimea
Applying for an exemption to place a medical device on the market
- Service
- Nationwide
- Public service
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 device is necessary for the protection of public health or the alleviation or treatment of a serious illness or injury of a patient;
- n ...
Do the following
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.
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Finnish Medicines Agency FimeaResponsible for the service
Finnish Medicines Agency FimeaText edited by: Finnish Medicines Agency Fimea
Updated: 2/1/2026