Finnish Medicines Agency Takes Over Device Regulation
At the beginning of this year, Finland’s medicines regulator (Fimea) took over the supervision of medical devices, operators and device trials from Finland’s National Supervisory Authority for Welfare and Health (Valvira).Finland, which is a part of the EU, will now use Helsinki-based Fimea to supervise marketed devices and those coming to market, as well as to govern the requirements related to the health care and social welfare information systems and the marketing of devices. Valvira previously served as the competent authority for devices and notified bodies.
“The purpose of the transfer is to concentrate expertise related to the quality, efficacy and safety of medicines 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,” Fimea said.
Finland’s government advanced the proposal for the switch last November.
Fimea will also take over the guidance, supervision and registration duties related to biobanks, the licensing and supervision of duties on the medical use of human organs and tissues, related to embryo research and duties 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. “The most important connecting factor, however, is the safeguarding and improving of patient safety that is achieved via supervision, in addition to the guidance and advice of operators.”
New contact details include:
- Adverse incident reports: [email protected]
- Inquiries by the authorities and general inquiries: [email protected]
- Clinical trials on medical devices and performance evaluations: [email protected]
- Registration matters, export certificate requests: [email protected]
Fimea