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
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.”