Thank you for your questions. Please find our response below, covering the overall scope of
your inquiries.
Millions of people have safely benefited from medical devices and can now live healthier, more
productive and more independent lives. Life is unimaginable today without the hundreds of
thousands of medical devices in our hospitals and in our homes.
European regulation
Both the US and EU systems require a device to be safe and to perform as intended, with each
system using a different mechanism to do so. Europe has chosen an approach which makes
sure that the safety, science and technology of devices are sound, while allowing national health
authorities to assert control should public health or safety be at risk. Europe has a robust market
surveillance system which looks at the safety of devices throughout their full life-cycle. This
system allows national governments to identify potential incidents early and enables them to act
appropriately. This point is further emphasised and strengthened through the new Medical
Device Regulation (MDR). MDR will replace the European Directives system which has been
used to approve and regularly re-certifies safe and effective devices for the last 30 years.
Data transparency
The MDR will render an unprecedented amount of clinical data and post-market surveillance
information available to the public and to healthcare professionals, via the new Eudamed
database. Adequate access to information is important in the public interest to protect and
empower patients and healthcare professionals and to allow them to make informed decisions.
We fully support this point.
There are several tools available through the Eudamed database to provide this information,
such as the ‘Summary of Safety and Clinical Performance’.
At the same time, we have maintained that this system should avoid disclosure of companyproprietary and confidential patient data. Additionally, the text of the new regulation clearly
specifies that (Art. 73.3 (b)) commercially confidential information shall be disclosed in the
presence of an “overriding public interest”, which we entirely support as a reasonable standard
for protecting patient safety.

Medical Device Innovation
By providing useful tools to physicians, medical devices help to advance the practice of
medicine. The Don’t Lose the 3 campaign you refer to raised three critical points about what we
should preserve and improve within the European system. We advocated for providing needed
solutions to patients as early as possible, making the system even safer through more aligned
and stricter oversight of those who approve products, and supporting the innovativeness of the
European system. We still see these as key elements of a robust, strong Medical Device
Regulation.

 Interaction with policymakers
MedTech Europe represents the medical devices industry in Brussels, and in this capacity, it is
our responsibility to participate in discussions relevant to our industry. We provide input to
policymakers to support their understanding of our industry, with the hope that this information
will help them shape a sustainable and appropriate regulatory environment that better serves
patients. As the voice of the medical device sector, we provide our expert knowledge about the
potential impact of any legislative measure under discussion.
Notified Bodies
Notified Bodies are third-party conformity assessment bodies, who are designated and
controlled by Member State competent authorities and the European Commission. They are
selected for the expertise, impartiality, transparency and independence of their staff. Numerous
geographies around the world use conformity assessment bodies as the basis for premarket
evaluation of medical devices.
The explanation you gave of what happened when journalists submitted fake claims to notified
bodies is false. Notified bodies never issued a certificate (i.e. gave a green light) for a fake
medical device. Instead, they agreed to take the dossier from the manufacturers and then
review the files. Nothing we have seen indicates that a certificate was ever issued.
The new Medical Device Regulation provides a stronger mandate to notified bodies in their
assessment of medical devices before they can be placed on the market. Furthermore, it
strengthens the oversight of these bodies by the European Commission and national
authorities. The new rules also ensure that notified bodies assess with the same high standard
throughout the EU. Currently notified bodies are re-designated by national competent authorities
and the European Commission against the requirements of the new Medical Device Regulation.