Valvira becomes the competent authority for medical devices and notified bodies as of 26 Nov 2017
The Government is proposing amendments to the Medical Devices Act. The proposed amendments have to do with the first phase of the national implementation of the EU Regulation on medical devices and the EU Regulation on in vitro diagnostic medical devices.
National legislation will remain in force insofar as the new Regulations do not provide otherwise. The new Regulations impose stricter criteria on medical devices and actors in the sector. Official duties will also increase considerably, particularly in international contexts, where the aim is to bring greater coherence to EU-level criteria and monitoring.
The proposal involves adding specific provisions to the Act to make it consistent with the present situation, naming the National Supervisory Authority for Welfare and Health (Valvira) as the competent authority responsible for medical devices and notified bodies as per the EU Regulations. The proposal does not address the issue of where the function of monitoring medical devices will be located in the context of the central government’s reform of the permit and monitoring administration. The proposal includes language criteria for the various documents provided for in the EU Regulations. Under the proposal, the Act would allow the use of English in a wide range of official documents, in keeping with the international nature of the medical device market.
It is intended that the revised Act should enter into force as quickly as possible. The provision concerning the competent authority is meant to be applied as of 26 Nov 2017.
Government proposal to Parliament for an Act amending the Medical Devices Act (Stm.fi) (in Finnish)
Regulations concerning medical devices (Valvira.fi) (in Finnish)
Heikki Mattlar, Head of Unit, Senior Officer
Tel. +358 (0)295 209 506