The supervision of medical devices will be transferred from Valvira to Fimea
The supervision of medical devices, operators in the sector and device trials will be transferred from Valvira to Fimea as of 1 January 2020. Additionally, guidance, supervision and registration duties related to biobanks, supervision duties related to embryo research and gene technology legislation, as well as certain the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues that were under Valvira’s responsibility, will also be transferred to Fimea.
The supervision of medical devices focuses on the supervision of the conformity of medical devices and supplies and operators in the sector based in Finland. The supervision of the conformity of products covers all medical devices already placed on the market as well as their proper use. Additionally, the supervision covers the fulfilment of the essential requirements pertaining to healthcare and social welfare information systems and the marketing of medical devices.
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.
A medicines authority also serves as the competent authority for medical devices in many other countries, for example, in all Nordic countries. “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,” says Johanna Nystedt, Director of Supervision and Licences. “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.”
Valvira and Fimea will continue to engage in close cooperation in patient safety matters concerning health technology.
New contact details:
Adverse incident reports: firstname.lastname@example.org
Inquiries by the authorities and general inquiries: email@example.com
Clinical trials on medical devices and performance evaluations: firstname.lastname@example.org
Registration matters, export certificate requests: email@example.com
Service mailboxes for biobank supervision:
Johanna Nystedt, Director of Supervision and Licences
tel. +358 295 223 210