European medtech industry criticises proposed EU medical device
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
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:
- Only the best Notified Bodies should be allowed to approve
medical devices to the market.
- A systematic control procedure is necessary to improve the
system and increase patient safety.
- Increase stakeholder involvement to ensure that the opinions
of essential healthcare actors are heard.
- 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.
- Clinical evidence needs more clarity.
- Enhance vigilance and market surveillance.
- Clear science based classifications are needed to avoid the
currently proposed arbitrary reclassification of families of
medical devices without any scientific or other justification.
The details of the recommendations can be found in the position
“Towards a regulation that guarantees patient safety, ensures
patient access and keeps innovation in Europe”.
The campaign "Don't lose the 3" is at: