Sweden: Clarification of obligation to perform clinical evaluations

28 July 2010

Catrin Agerhäll, Helena Siljeström

New rules and regulations concerning medical devices entered into force in Sweden on 21 March 2010. The changes are based on the EU 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.

One of the most important changes in the new regulations is the clarification of the original obligation on manufacturers to perform clinical evaluations to ensure that the medical devices comply with the essential requirements regarding, for example, product safety, performance and minimisation of potential side effects, as prescribed in the regulations.

The Swedish Medical Products Agency, which is responsible for market surveillance related to the law on medical devices, has noted a significant increase in questions specifically related to clinical evaluations since the new rules and regulations entered into force.