Finland: legislation on medical devices

By Ella Mikkola, Hanna Seppänen


The Government Bill (HE 46/2010 vp) proposing new legislation on medical devices was introduced to the Finnish Parliament on 9 April 2010. The Government Bill was intended to implement in Finland Directive 2007/47/EC amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

Member States were supposed to adopt and publish the laws, regulations and administrative provisions necessary to implement the Directive by 21 December 2008 and to apply such measures from 21 March 2010 onwards.

Finland has therefore not implemented the Directive within this deadline but according to Ministerial Counsellor Pekka Järvinen of the Ministry of Social Affairs and Health, the new legislation on medical devices should become effective as soon as possible after Parliament has passed the law, probably by the start of July 2010.  

As of 1 November 2009 the monitoring of the manufacturing and marketing of medical devices became part of the National Supervisory Authority for Welfare and Health (Valvira). The Finnish Medicines Agency (Fimea) is the authority responsible for the authorisation and supervision of medicinal products whilst Valvira is the authority responsible for medical devices.