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Fimea designates a third notified body under the IVD Regulation in Finland, strengthening Finland’s status as one of the leading EU countries by the number of notified bodies
Fimea has designated SGS Fimko Oy as a notified body in accordance with the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVD Regulation). The designation was published on the European Commission website in the Nando database on 21 October 2025.
SGS Fimko is the third notified body designated by Fimea in accordance with the IVD Regulation. As a result, the EU now has a total of 19 notified bodies under the IVD Regulation, three of which are based in Finland.
With the designation, the number of notified bodies operating in Finland under the IVD Regulation is now the second largest in the EU by country, as only Germany has more with a total of four notified bodies. Italy and the Netherlands each have two notified bodies under the IVD Regulation. The designation of SGS Fimko thus further strengthens Finland’s strong position and expertise in the diagnostic industry.
Notified bodies are independent external assessment bodies carrying out conformity assessments under the Regulation. In order to act as a notified body under the Regulation, the designation must be sought 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 also actively participates in cooperation between European authorities in the evaluation and supervision of notified bodies.
Medical device manufacturers are free to use any European notified body with a suitable area of competence for conformity assessments. Notified bodies appointed in Finland serve not only domestic customers but also international customers.
Read more:
Fimea online news article 24 February 2025: Extension to the scope of the Finnish notified body
NANDO (New Approach Notified and Designated Organisations) Information System
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- Jari Knuuttila, Chief Specialist, tel. +358 29 522 3274
- Mika Erjanne, Senior Specialist, tel. +358 29 522 3259
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