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Public debate in European Parliament on future EU medical device legislation focused on the need for safety and timely access

Posted on 28.02.2013

Medical device manufacturers agree with the views of doctors, patients and some Members of European Parliament expressed at a hearing on 26 February that the current system must be significantly improved to increase patient safety, maintain timely patient access to the latest life-saving technology and keep medtech innovation in Europe. Panellists at the hearing proclaimed the need for greater transparency, traceability of devices and strict control of notified bodies—the entities charged with reviewing new medical devices.

A large part of the debate focused on how to organise the approval process of high risk devices. Industry expressed its view to significantly strengthen the decentralised device-specific approval system and not move towards a centralised pre-market authorisation system as seen in the US. Independent research concludes that patients subject to a centralised pre-market authorisation system, such as the US FDA system, wait 3 to 5 years longer for access to the latest life-saving medical devices.Research also clearly concludes that faster approvals in Europe do not compromise patient safety. Industry does support the idea that only a limited number of highly specialised Notified Bodies with proven clinical expertise should be eligible to approve Class III devices.

A concern was raised that European patients do not enjoy faster access than US counterparts because Europe’s national health systems are slow in reimbursing new technologies. While the approval of a medical device is for the whole of Europe, reimbursement is organised differently via national health systems. Early patient access in most European countries is ensured through special payment mechanisms and / or leveraging available reimbursement for innovative medical technologies. The existing special payment mechanisms accelerate access and bridge the period between product approval and new specific reimbursement for innovative technology. A recent study of the European Health Technology Institute (EHTI) conducted by the London School of Economics (LSE) reported that approximately 70% of countries surveyed use special payment mechanisms for innovative technologies and these are considered to be effective in integrating new technologies into the health system.

“We welcome the growing awareness of the benefits of the European device-specific approval system. We have made it very clear on various occasions that we want to significantly improve this decentralised system to guarantee the highest safety and avoid unnecessary delays of lifesaving medical technologies reaching patients. The European Commission’s proposal is a step in the right direction and we welcome many of the recommended measures. However, the proposed scrutiny mechanism is inappropriate because it does not contribute to patient safety and is essentially a duplication of reviews. We have suggested replacing the scrutiny mechanism with a systematic control procedure. We were surprised to hear doubts about the fact that European patients have faster access to safe medical technologies.  We acknowledge that national health systems reimburse devices in different ways and at different speeds, but there is simply no doubt that these life-saving devices are available to European patients sooner than anywhere in the world. The fact remains that a technology like renal denervation is already saving the lives of European hypertension patients whose condition cannot be treated solely by pharmaceuticals, while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved.” says Serge Bernasconi, Chief Executive Officer of Eucomed.

To clarify what is at stake with the current revision of the European medical device legislation, Eucomed has launched the campaign “Don’t lose the 3”. The campaign showcases the advantage that Europeans currently enjoy and explains what changes need to be made to the current European system to make sure that Europeans continue to have timely access to safe, live-saving medical devices.

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Positions, research reports, videos, visuals and other materials regarding the Revision of the Medical Devices Directive are available at the dedicated section of the Eucomed website.


About Eucomed

Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. Eucomed is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information visit