Following the publication of proposed legislative changes as part of a new European Medical Device Directive (MDD), Eucomed — the industry association representing European medical device manufacturers — has issued a press release stating the association's position on the proposed changed. In summary, Eucomed says that the industry welcomes most measures in the proposal. But it voices strong concern over a new scrutiny procedure, which Eucomed says will hamper innovation while resulting in patients waiting longer for life saving medical technologies without improving safety. The full release is published below.
The recent PIP breast implant incident has made it crystal clear that healthcare actors must pull together to ensure that such a case of fraud never happens again. The medical device industry unanimously agrees that an overhaul of Europe’s regulatory framework is necessary to improve the system that has been the world’s fastest in providing life saving technologies to patients without compromising safety. The European industry association Eucomed welcomes most of the recommended measures in the European MDD proposal but voices strong concern with regards to the scrutiny procedure as it will ultimately harm patients and will negatively impact European governments and industry.
Besides the scrutiny procedure, most of the measures proposed by the European Commission, including more rigorous controls on manufacturers, are welcomed by industry as they improve patient safety, do not unnecessary delay patient access to life saving medical technologies and do not hamper innovation. The value based innovations of the medical device industry have proven to not only improve the lives of millions of patients but also play an important role in making European healthcare systems more efficient, which has become a priority for all European governments.
Industry strongly supports stricter controls and monitoring of notified bodies — professional organisations that are authorised by national governments to assess the safety of medical devices before allowing them to be made available to patients (pre-market approval). Other recommendations such as increased coordination on vigilance and the establishment of a comprehensive registration database, that governments and patients can access, are welcomed as they will improve the overall safety and transparency for patients in Europe. Similar suggestions, including the introduction of a Unique Device Identification system, have been made by industry and can be found in its position paper A New EU Regulatory Framework for Medical Devices. Industry proposes a balanced six-step approach that would keep the positive aspects of the current European system while fixing the weaknesses and addressing important issues such as ageing populations and increasing pressure on national healthcare budgets.
Industry’s main concern lies with the proposed scrutiny procedure. This procedure will fundamentally change the current system and will not lead to the desired outcome of increased safety for patients. The measure would address some political calls to move the system towards a centralised pre-market authorisation system as found in the United States but will ultimately result in harming European patients and negatively impact mostly European small and medium sized enterprises (SME). Recent reports from respected academics and researchers have shown that centralised pre-market authorisation systems deny patients life saving medical technologies as patients must wait on average three to five years longer for the same devices than those in Europe while delivering no additional safety.
Former surgeon and Eucomed Chairman Dr Guy Lebeau MD (pictured): “I urge all decision makers who want to make fundamental changes to the European system for medical devices to tread with caution. European patients and European medical research and innovation have benefitted heavily from a system that is the world’s fastest in providing patients with life saving technologies while not compromising safety. I fully agree that changes need to be made to the current regulatory framework but let’s make sure we keep the best system for patients and medical progress in Europe." The current legislative framework in Europe is viewed by many as one that not only delivers the best results for patients but also encourages innovation, which is especially important for the 22,500 European SMEs who employ approximately 500,000 people.
European industry has not only committed to playing its part in improving the current regulatory framework but will also assist national healthcare systems to remain sustainable. Industry will focus its efforts on delivering value based innovations, which not only improve the health of patients but are also cost-effective. Recent examples of value-based innovations are minimally invasive surgical techniques, blood glucose monitoring systems for diabetes and multifocal intraocular lenses for cataract treatment. In order to speed up the necessary transition towards more value based innovations, Eucomed has developed a five-year strategy, called A Contract for a Healthy Future, which has been unanimously adopted by all its members. Industry is investing in resources and research in Europe to provide governments and payers with more socio economic data that prove the cost effectiveness of medical technologies in addition to the increased benefits for patients.
“European industry is committed to providing medical technologies that improve people’s lives while at the same time being cost effective. Europe has become a leader in healthcare innovation, which is now more than ever needed to cope with the increased pressure on national healthcare budgets. The current regulatory framework has provided a high level of safety for patients in Europe without delaying them access to life saving medical technologies, which will always remain paramount. But let’s not unnecessarily push away Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed”, says Serge Bernasconi, chief executive officer of Eucomed.