Press Release: Commission launches public consultation on medical devices

The European Commission launched a public consultation on 8 May, 2008, with the aim to modernise and simplify the legislation on medical devices. Since the nineties the safety of medical devices in Europe has been guarded by a series of medical devices Directives. Their introduction also contributed to free trade, innovation and competitiveness within Europe. However, in recent years a number of drivers came into play that require a revisit of this legislation. Experience indicated that the current system does not always offer a uniform level of protection of public health in the European Union. New and emerging technologies present new challenges to the current framework, highlighting gaps and pointing to a certain scarcity of expertise. In addition, in recognition that the medical devices market is a global one, to keep European industry competitive, the Community regime needs to further converge on globally applied rules. And finally, the legal framework has been criticised as being too fragmented and difficult to follow and fraught with national variation. This situation has motivated the Commission to consider a revision of the legal framework in order to meet the growing expectations from European citizens.