Fimea supervises the regulatory compliance of medical devices and the operators in the sector in Finland. The supervision of the regulatory compliance of devices pertains to medical devices placed on the market as well as their professional use and maintenance. The supervision is carried out in collaboration with other EU authorities.
In addition, Fimea supervises the marketing of medical devices, handles adverse incident reports, issues certificates of free sale, and grants clinical trial investigation and derogations for medical devices.
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Adverse incident reports: [email protected]
Inquiries by the authorities and general inquiries: [email protected]
Clinical trials on medical devices and performance evaluations: [email protected]
Registration matters, export certificate requests: [email protected]