Eucomed voices concern over scrutiny procedure in EC proposal for medical device regulations

3 October 2012

The European medical device industry association Eucomed has announced that it welcomes most of the recommended measures in the European Medical Device Directive 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 [1], including more rigorous controls on manufacturers, are welcomed by industry, says Eucomed, 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.

Points of support

Eucomed says industry strongly supports stricter controls and monitoring of notified bodies — professional organisations that are authorized 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 [2]. 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 as it 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: “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.

Eucomed has developed a five-year strategy A contract for a healthy future [3] 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.

Further information

1. See MTB Europe news: European Commission proposes new regulations for medical devices

2. Eucomed position paper A new EU regulatory framework for medical devices:

3. The Eucomed report A contract for a healthy future:

4. See also Clinica article: US PMA no more of a safeguard than EU CE mark yet drawbacks significant, report finds


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