Extension to the scope of the Finnish notified body

Fimea has extended the scope of SGS Fimko Oy’s notified body designation under the Medical Devices Regulation (2017/745, MDR) with its decision. In practice, this means that SGS Fimko Oy can now offer services more comprehensively to manufacturers of various types of medical devices. The extended scope was published on the European Commission’s website in the   European Commission website in the Nando database on 22 February 2025. All measures that increase the capacity of notified bodies are important for bringing new innovative devices to the market. 

Notified bodies are independent third-party assessment bodies carrying out conformity assessments under the Regulation. In order to act as a notified body under the Regulation, the designation must be applied for from the national authority. In Finland, notified bodies for medical devices and in vitro diagnostic medical devices are designated and supervised by the Finnish Medicines Agency Fimea. Fimea actively participates in cooperation between European authorities in the evaluation and supervision of notified bodies. 

The manufacturer of a medical device is free to use any European notified body with a suitable area of competence. Notified bodies appointed in Finland serve not only domestic customers but also international customers. 

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NANDO (New Approach Notified and Designated Organisations) Information System: Notification details