Fimea designates a new notified body under the IVD Regulation in Finland

Fimea has designated Sertio Oy from Tampere, Finland as a notified body in accordance with the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVD Regulation). This was already the second Finnish designation according to the IVD regulation. To date, only twelve notified bodies under the IVD Regulation have been designated throughout the EU, of which two are located in Finland. The designation was published on the European Commission website in the Nando database on 31 October September 2023. This can be considered as significant news to Finnish and European diagnostics industry.

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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Fimea designates the first notified body under the IVD Regulation in Finland

New EU Regulation on in vitro diagnostic medical devices comes into force on 26 May 2022 (in Finnish)

NANDO (New Approach Notified and Designated Organisations) Information System