Eucomed calls for improvements in EU medical technology legislation

26 Oct 2010

Eucomed, the European medical technology industry association, has called for improvements in the current ‘notified body based system’ for medical technology certification in Europe, but does not believe it requires a major overhaul.

Revision of the EU legal framework for medical devices was a key topic during the third annual MedTech Forum in Brussels on 12-14 October. 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 tax payers’ money.

 Eucomed says it recognises the need to adapt and improve EU legislation in order to guarantee access to safe, life-enhancing medical care for patients and consumers while sustaining the industry’s drive for research and innovation.

To achieve this Eucomed strongly believes that the current ‘notified body based system’ requires improvements in implementation but not a major overhaul.

It says that 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. To better align safety levels and administrative procedures throughout the EU, Member States should be presented with effective tools to improve co-ordination of their management of the system.

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.”

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.”

During the opening session of the MedTech Forum the newly announced ‘Innovation Union’ was discussed, which sets out a strategic approach to innovation driven by the highest political level. The Innovation Union is the catalyst for achieving the goals of the Europe 2020 strategy for a smart, sustainable and inclusive economy. The pilot project of the Innovation Union is built around an active and healthy ageing society.

Guy Lebeau, Chairman of Eucomed said: “We are very pleased and excited that the first project of the Innovation Union is focused on health. We gladly accept the invitation to partner with the different stakeholders that take part in the initiative and look forward to jointly developing a vision for innovation for the medical technology industry. In our industry innovation often comes from micro-collaborations between health professionals, academia and SMEs, which account for 80% of our sector.”


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