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Eucomed calls for better control measures in proposed EU device legislation
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The European medical technology industry association, Eucomed, has released a position paper in response to the European Medical Device Directive proposal that agrees with many aspects of the European Commission’s medical device legislation proposal, but focuses on seven key areas of improvement.
“The proposed scrutiny procedure is a ‘needle-in-a-haystack’ approach which should be replaced by a systematic procedure that prevents ‘the needle’ to land in the haystack in the first place. Only then will we successfully increase patient safety and prevent unnecessary delays of medical devices reaching patients,” Serge Bernasconi, chief executive officer of Eucomed, stated in an association press release. “We suggest a systematic control procedure that makes sure we increase the safety of all medical devices, which is in the end the collective objective of all stakeholders. We look forward to continue our discussions with policymakers and other parties and are confident that patients in Europe will be the winner in the end.”
According to the Eucomed release, besides the monitoring and control of Notified Bodies, Eucomed proposed the following additions to the European Medical Device Directive proposal, which are detailed in its position paper:
- only the best Notified Bodies should be authorized to approve medical devices;
- replacement of the ‘Commission scrutiny procedure’ in the legislation with a systematic control procedure to improve the system and increase patient safety;
- greater stakeholder involvement;
- greater transparency and traceability for doctors, patients, industry and other stakeholders;
- further clarity of clinical evidence and clear, appropriate requirements for clinical use;
- increased vigilance of adverse events and more market surveillance; and
- clear science-based medical device classifications.
In addition, Eucomed stated factors such as scope, economic operators, reprocessing, standards, guidance and specifications, early scientific advice, as well as governance, funding, transition periods, hazardous substances and delegating and implementing acts need more attention to avoid hampering innovation and compromising patient safety.
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