Medical device distributors not required to submit device notifications until further notice
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 devices to the Finnish Medicines Agency. 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 until further notice.
Fimea’s electronic submission service for medical devices was launched on 2 May 2023. Through the service, the distributor can submit and update their operator details, but the service is not used to submit data on distributors’ devices.
Electronic submissions for medical devices will be opened on 2 May 2023 - Fimea.fi - Fimea (in Finnish)
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
Ytterligare information ges av
- Susanna Peltoniemi, Head of Unit, 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
- Fimea e-mail addresses are in the format email@example.com