The health technology guidance and supervision tasks will be moved from Valvira to Fimea
The Government proposes that the supervision of medical devices and supplies, operators in the field and device inspections are transferred from Valvira to Fimea.
The following will also be transferred to Fimea: the guidance, supervision and registration duties related to biobanks, the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues, duties related to embryo research, and the supervision duties under the Gene Technology Act.
The purpose of the transfer is to improve the expertise concerning the quality, efficacy and safety of medicines and devices, and to gain synergy benefits as a result. Valvira and Fimea will cooperate closely in patient safety matters concerning health technology.
The Government gave the proposal to the Parliament on Thursday 7 November 2019. The laws are due to enter into force on 1 January 2020.
Markus Henriksson, Director General (Valvira)
Tel. +358 295 209 300
Eija Pelkonen, Director General (Fimea)
Tel. +358 29 522 3100