Finland: New legislation on medical devices passed in Finland

By Ella Mikkola


The Finnish Parliament has passed new legislation on medical devices in Finland. Most sections of the new legislation entered into force on 1 July 2010.

By passing the new legislation, Finland has implemented several medical device related directives, namely Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC concerning medical devices and Directive 98/79/EC on in vitro diagnostic medical devices, as amended.

In Finland, Valvira (the National Supervisory Authority for Welfare and Health) monitors the manufacture and marketing of medical devices while Fimea (the Finnish Medicines Agency) handles the tasks associated with medicinal products.