European Parliament urged to focus on need for safety and timely access to medical devices

28 February 2013

 Eucomed has issued a statement that it welcomes stakeholder calls at a public hearing of the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 26 February, for much needed improvements to Europe’s regulatory system for medical devices.

 At the hearing, various stakeholder groups noted that a centralised authorisation system for high risk devices would not lead to the desired increase of safety and bring unnecessary delays in patient access of medical technologies.

 Eucomed points out that research shows that a centralised system does not increase safety and patients subject to such a system wait on average at least three years longer for receiving life-saving medical devices compared to patients in Europe. Medical device manufacturers agree with the views of doctors, patients and some Members of European Parliament expressed at the hearing 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 three to five 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.

Slow reimbursement for medical technology

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 payments for 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.

Industry welcomes proposals with reservations

Serge Bernasconi, Chief Executive Officer of Eucomed, said, “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.”

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 highlights 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.

The website is at:


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