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Supervision of devices referred to in Annex XVI of the Medical Device Regulation to begin in autumn 2022
The requirements applying to the devices referred to in Annex XVI of the Medical Device Regulation are due to enter into force in autumn 2022. The decisions issued by the European Commission will affect the timetable. According to current information, the common specifications related to the supervision of the devices referred to in Annex XVI will be completed in the European Commission in early 2022. The transition period for organising the supervision is six months from the publication of the common specifications.
Operators affected by this must follow the information communicated by the Commission and Fimea.
In Finland, Fimea is the supervisory authority for the devices listed in Annex XVI of the Regulation. In addition, new national legislation will supplement the Regulation.
Other supervisory authorities and their areas of responsibility:
- Finnish Safety and Chemicals Agency (Tukes): cosmetic products, chemicals and the safety of services
- Radiation and Nuclear Safety Authority (STUK): use of radioactive devices in services
- Municipal health protection authority: supervision in compliance with the Health Protection Act.
Ask more
- Johanna Ekholm, johanna.ekholm@fimea.fi
- Susanna Peltoniemi, susanna.peltoniemi@fimea.fi
- E-mail addresses are in the format firstname.lastname@fimea.fi