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EU legislation requires “robust framework for a healthier future”


14 October, 2010  

Current European legislation on medical care requires adaptation and improvement to better align procedures throughout the EU, according to Eucomed, the European medical technology industry association.

Eucomed says the legislative move would guarantee access to safe, life-enhancing medical care for patients and consumers while sustaining the industry’s drive for research and innovation.

The association believes the current “notified body-based system” requires improvements in implementation but not a major overhaul.

It says the regime of certification with CE marking has given patients and consumers in Europe “the fastest access to the most innovative devices with the highest quality and safety standards in the world”.

Eucomed argues that, to better align safety levels and administrative procedures throughout the EU, member states should be presented with effective tools to improve coordination of their management of the system.



Revision of the EU legal framework for medical devices was a key topic during the third annual MedTech Forum in Brussels. From a patient, European Commission, FDA and Member State perspective, the policy debate focused on whether the new rules would put the EU ahead in both patient-centred thinking and smart use of taxpayers’ money.



Jacqueline Minor, Director Consumer Affairs of DG SANCO, and responsible for the EU Medical Device regulatory framework, stated: “Through the Recast we want to shape a robust framework that paves the way for a healthier future where responsible innovation can flourish and meet the needs and expectations of patients and consumers.

“Achieving our objectives of the highest level of health protection for all, while at the same time promoting the competitiveness and the innovation capacities of the medical device sector, calls for a continuous dialogue between us all – patients, consumers, healthcare professionals, industry and regulators.”



In reaction to the session, John Wilkinson, Chief Executive of Eucomed, commented: “The current EU system is ahead in terms of patient access and safety. European patients and consumers benefit from the latest in medical technology nearly two years ahead of US patients and up to five years ahead of Japanese patients.

“Globally, the EU safety requirements form the basis of the gold standard in the global regulatory model called GHTF mainly because they form a robust set of safety requirements capable of dealing with diverse and novel technologies. We therefore support adapting the current system, making it more effective, while avoiding bureaucracy that will neither benefit the patient, the tax payer nor the industry.”



Eucomed