European medtech industry criticises proposed EU medical device legislation

25 February 2013

Eucomed, the European medical technology industry association, has called for changes to the European Medical Device Directive proposal and has launched a campaign, called "Don't lose the 3", to ensure legislators are aware of the objections and bring awareness of the period of potential delay in technology adoption that may arise from the legislation.

The Association says that the industry welcomes many of the recommended measures but unanimously agrees that improvements in seven key focal areas are necessary to guarantee the delivery of safe, innovative medical technology.

It says that more improvements to the proposal are necessary, especially with regards to the controls and monitoring of notified bodies. In particular it recommends a “systematic control procedure” consisting of seven critical measures as an alternative to Commission’s proposed random scrutiny procedure as this will more effectively achieve the common objective of increased patient safety.

Eucomed says many of the recommended measures are welcomed by industry as they: (1) improve patient safety, (2) do not unnecessary delay patient access to medical devices that save or improve lives and (3) do not hamper innovation. However, more stringent control measures on Notified Bodies are necessary to ensure the highest safety of medical technology for patients in Europe.

The current proposed measures such as the ability for the European Commission to further specify the regular checks of manufacturers by Notified Bodies are not sufficient. 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 patient safety.

“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. 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,” said Serge Bernasconi, Chief Executive Officer of Eucomed.

Besides the monitoring and control on Notified Bodies, industry suggests improvements on seven key focal areas and ten additional topics. The seven focus areas are:

  1. Only the best Notified Bodies should be allowed to approve medical devices to the market.
  2. A systematic control procedure is necessary to improve the system and increase patient safety.
  3. Increase stakeholder involvement to ensure that the opinions of essential healthcare actors are heard.
  4. Greater transparency and traceability is critical to ensure that patients, doctors, industry and other stakeholders have access to clear information about the medical devices they use.
  5. Clinical evidence needs more clarity.
  6. Enhance vigilance and market surveillance.
  7. Clear science based classifications are needed to avoid the currently proposed arbitrary reclassification of families of medical devices without any scientific or other justification.

Further information

The details of the recommendations can be found in the position paper “Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe”.

The campaign "Don't lose the 3" is at:


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