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No surprises in draft report on medical devices from Rapporteur Roth-Behrendt

Posted on 19.04.2013

Brussels, 19 April 2013 – The European medical technology industry association Eucomed takes note of the measures proposed by Rapporteur Mrs Roth-Behrendt in her draft report on medical devices for the Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament. The draft report is a step backward for patients, healthcare systems and Europe. The Rapporteur calls for a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patients in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety. In addition, the measure would lead to the creation of a new enormous bureaucratic system with no benefits. Important to note is that this is not the final report but the position of the Rapporteur, who will now enter discussions with her Parliamentary colleagues of the ENVI Committee on the content of the report. Members of the ENVI Committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the European Parliament.

Industry continues to strongly believe that a move towards a centralised pre-market authorisation procedure is not the right way forward. Multiple scientific reports and studies clearly indicate that a centralised pre-market authorisation system for medical devices, similar to the one in the US, will deliver no additional safety benefits for patients and will cause unnecessary delays of up to 3 years in lifesaving medical devices reaching patients. A case in point is the example of an innovative medical technology like renal denervation for the treatment of severe, uncontrolled hypertension in patients whose condition cannot be treated solely by pharmaceuticals. This technology is already saving the lives of patients in Europe while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved.

Industry recognises that the current system needs an overhaul and acknowledges that change is necessary to improve Europe’s medical device regulatory framework. Industry has provided clear suggestions for necessary and effective improvements to strengthen the system, especially with regards to the 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). Industry believes that a comprehensive systematic control procedure is necessary that includes measures to ensure that Notified Bodies are meeting the highest quality standards as well as ensuring that the clinical evidence for medical devices is being properly reviewed by independent clinical experts. This systematic control procedure would replace the proposed scrutiny procedure (article 44), which is essentially a duplication of reviews and checks and does not contribute to improving patient safety.

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 showcases the advantage that patients in Europe currently enjoy and explains what changes need to be made to the current European system to make sure that patients continue to have timely access to safe, lifesaving medical devices.

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More information on the Revision of the EU Medical Devices Directives

Eucomed’s position paper, detailed fact sheets, patient videos and visuals related to the Revision of the EU Medical Devices Directives are available on

To know more about “Don’t lose the 3” campaign visit

About Eucomed

Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. Eucomed is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information visit