The Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices
The Finnish Medicines Agency Fimea has issued a new administrative regulation on the registration of economical operators and devices. The new administrative regulation 2/2021 entered into force on 17th of August in 2021 and repeals the previous administrative regulation issued by Valvira (2/2010). The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland.
Before placing medical devices on the market or making them available, the economical operator must register to Fimea of its activities and devices. The registration of medical devices is a two-step process, including operator and device registration. Registration shall be done either to the Eudamed database or to the Fimea national device register, depending on the role of the operator. Also, it needs to be taking into account that device registration module in Eudamed is not yet available.
Read more on Fimea’s webpages (only in Finnish): https://www.fimea.fi/-/fimean-uusi-maarays-ohjaa-laakinnallisiin-laitteisiin-liittyvaa-ilmoitusmenettelya