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
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
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
"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
"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: