First, the current system does not always offer a uniform level of protection of public health in the European Union, with new and emerging technologies stretching the framework, exposing gaps and highlighting a shortage of expertise.
At the same time, the medical devices market is global and to keep industry competitive the European regime needs to further converge on globally applied rules.
And as ever, the legal framework is fragmented, difficult to follow and fraught with national variation.
There is a significant amount at stake, both from the perspective of healthcare and of high tech markets. Europe represents 33 per cent of the global medical device market – worth about €187 billion and growing at roughly 5 to 6 per cent a year. While the medical devices represent around 6 per cent of healthcare spending in Europe, the sector employs some 435,000 people in more than 11,000 businesses. More than 80 per cent of these are small and medium-size enterprises.
Launching the consultation, 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.”
Rules relating to the safety and performance of medical devices were harmonised in the EU in the nineties, beginning in 1990 with a directive on active implantable medical devices and followed in 1993 by a directive on medical devices and in 1998, by rules for in vitro diagnostic medical devices.
These three directives aimed 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.
The Commission undertook to reform the legislation in, “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment” in 2005.
The Commission is looking for opinions on a number of issues including:
Are there medical devices that lie outside the legal scope and that need to be brought in?
Should cosmetic implants be regulated at the EU level?
How to avoid different levels of assessment being applied in the EU
How to ensure that the appropriate expertise is used in the evaluation of the most critical and innovative medical devices?
How to ensure that when an adverse reaction occurs there is swift, coordinated action across the EU
Suggestions to make the legislation more straightforward and understandable.
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