The location of notified bodies in Finland is an advantage for the diagnostics industry 

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Notified bodies play an important role in the introduction of medical devices to the market. Fimea appoints the notified bodies operating in Finland and supervises their operations. Small and new device manufacturers in particular benefit from the fact that the notified body can be found in Finland.

Notified bodies assess the compliance of medical devices

Before medical devices enter the European market, they must pass the conformity assessment described in EU regulations. This ensures that medical devices available to healthcare or consumers are functional and safe.

Chief Inspector Nelli Karhu from Fimea explains that notified bodies play a critical role when medical devices are placed on the market.

– Notified bodies are independent parties carrying out conformity assessment. Unlike medicines, CE marked medical devices do not have a marketing authorisation granted by the authorities but are assessed by notified bodies. 

Medical devices are divided into four risk categories based on their intended use. Devices other than those in the lowest risk category must be assessed by a notified body.

Two new notified bodies in Finland 

Fimea appoints the bodies that assess medical devices operating in Finland and supervises their operations. The designation of a new notified body is a long multi-stage process involving not only Fimea but also authorities of other EU countries.

However, notified bodies are not just an object of Fimea supervision, but an important part of a system that ensures the quality and safety of medical devices.

There are currently four notified bodies operating in compliance with the new legislation in Finland. Two of them have focused on medical devices in compliance with the MDR. In 2023, two new notified bodies focusing on medical devices in compliance with the IVD Regulation were appointed in Finland. 

A total of 40 notified bodies for MD devices operate in the EU and 12 for IVD devices. In proportion to the size of the country, Finland has a large number of notified bodies that assess in vitro diagnostic devices.

This is a significant advantage for the Finnish diagnostics industry. Small and new companies in particular benefit from the fact that the notified body can be found in Finland.

Read more:

A notified body ensures that a medical device is functioning and safe (Sic! magazine 2.2.2024, in Finnish)