Finnish Medicines Agency Takes Over Medical Device Regulation

At the beginning of 2020, Fimea, the Finnish Medicines Agency, took over the supervision of medical devices, operators and device trials from Finland’s National Supervisory Authority for Welfare and Health (Valvira).

The Government presented the proposal to the Parliament on Thursday 7 November 2019. The law that transferred the competences to Fimea entered into force on 1 January 2020.

According to the Agency’s representatives, the main reason for this change was “to concentrate expertise related to the quality, efficacy and safety of medicine and devices, and to gain synergy benefits as a result. Not only medicines, but also grafts of human origin intended for therapeutic purposes and medical devices must be in compliance with the applicable quality requirements”.

The main tasks of Fimea will be to:

·  Supervise marketed devices and those coming to market;

·  Assess the compliance with the requirements related to the health care and social welfare information systems and the marketing of devices (Valvira was the previous competent authority for devices and Notified Bodies);

·  Provide guidance and supervision on duties of registration to biobanks, licensing and on the medical use of human organs and tissues, with specific reference to embryo research under the Gene Technology Act.

“The transfer of duties creates good preconditions for the development of supervision processes in the supervision of devices, equipment and tissue establishments alike, and especially at their interfaces” said Johanna Nystedt, Director of supervision and licenses of Fimea.

Nevertheless, Fimea’s main goal to be achieved through the supervision process remains the safety of the patients, which should always be prioritized.

Andrei Panea

Regulatory Affairs Department


If you wish to place your product on the EU market, know more about the EU regulation on medical devices or how will the MDR  impact your business, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU legislation, will gladly answer any question you may have and assist you with your products’ compliance.

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