Medical device distributors not required to submit device notifications in 2022
Pursuant to section 49 of the Medical Devices Act (719/2021), an operator which distributes devices to retailers, health care and social welfare operators and to other professional users and makes devices available on the market in Finland shall submit a notification of its activities and device to the Finnish Medicines Agency. The deadline for submitting device notifications is 30 November 2022.
Due to the large number of devices to be notified and the difficulty in keeping device notifications up to date, Fimea has decided that these distributors will not be required to submit device notifications this year. Fimea's e-service tool for medical devices is still under construction. Once completed, it will enable user-friendly data collection and maintenance. In 2023, the supervisory fee charged to distributors subject to the notification obligation will be EUR 500.
Fimea will provide information on the contents of the register notifications to be made in 2023 at a later date.
- Medical Devices Act 719/2021 - Finlex
- Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
- Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices
- Susanna Peltoniemi, Head of Section, Medical Devices tel. +358 29 522 3270
- Sari Tuomaala, Coordinator, Control and registration of medical devices, tel. +358 29 522 3280
- Operator and device registration: firstname.lastname@example.org
- E-mail address format: email@example.com