Today the European Commission has launched a public consultation 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 have come into play that require a revisit of this legislation. Experience indicates 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.
Commission Vice-President Günter Verheugen, responsible for enterprise and industry policies, said: “We stick by our promise to reduce and simplify EU laws on medical devices as well as to protect public health to the greatest degree possible. Now we need the stakeholders' view on how to best ensure the continued safety for our citizens into the future while at the same time maintaining the right conditions for innovation and competitiveness in the medical device industry.”
Based on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the nineties, beginning in 1990 with Directive 90/385/EEC on active implantable medical devices and later followed in 1993 by Directive 93/42/EEC concerning medical devices and finally, in 1998, by Directive 98/79/EC on in vitro diagnostic medical devices.
These three legal texts form the core legal framework. Their aim is to ensure the functioning of the internal market and a high level of protection of human health and safety. They have been supplemented over time by six modifying or implementing Directives, including the last technical revision brought about by Directive 2007/47/EC.
The Commission, in its Communication to the European Parliament and Council, “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment”, COM(2005) 535, committed itself to simplify the Directives 90/385/EEC and 93/42/EEC as well as the blood derivatives Directives 2000/70/EC and 2001/104/EC. However, since 2005, a number of drivers have come into play that necessitates not only a simplification of these four texts but also a strengthening of the whole legal framework to give as high a level of protection of public health as possible.
Therefore, the Commission seeks the views of stakeholders on a number of aspects including:
Europe represents 33 % of a global medical device market of about 187 billion euro, with a growth rate of roughly 5% - 6%. The medical device sector represents about 6% of healthcare spending in Europe. The medical device industry employs approximately 435,000 individuals in Europe spread over more than 11,000 medical device business entities. More than 80% of these are small and medium size enterprises, i.e. employing less than 250 individuals.