Brussels, 12 November 2018
RESPONSES FOR THE INTERNATIONAL CONSORTIUM OF INVESTIGATIVE
JOURNALISTS (ICIJ) ON MEDICAL DEVICES
Introduction
A series of problems with medical devices over the last decade – most notably
with the PIP breast implants – revealed serious shortcomings in the existing EU
legislative framework on medical devices.
This is why the Commission proposed, already in 2012, a reform of the system to
enhance the safety and quality of all medical devices on the EU market.
Improving patient safety has always been and remains our key concern and the
aim of this review.
The new Regulations on medical devices and in-vitro medical devices, adopted by
the European Parliament and Council of Ministers in 2017, tighten controls of
medical devices before they are placed on the EU market, improve transparency
and strengthen market surveillance by national authorities.
The story doesn't end here, and challenges still lie ahead. The strict new rules on
safety and quality of devices require significant efforts to change the way of work
from all operators in the field before the new rules will fully apply in 2020 and
2022 respectively. Many aspects of how the rules will work in practice are still
under discussion among Member States.
Meanwhile, some of the reforms are already bringing tangible benefits. For
example, the strengthened oversight of the notified bodies is already ensuring
these are fit for purpose and improving their quality. In addition, the new EU
framework is also already becoming an important worldwide reference for
regulation on medical devices.
The Commission's action to
legislative framework

reform

the

existing

medical devices

As documented in the period 2002-2012, the Commission was made aware of the
need to reform the previous legal framework on medical devices, notably the
need for more stringent supervision of notified bodies, and therefore immediately
started work to revise the legal framework.
The shortfalls of the existing system for medical devices showed that reform was
urgently needed. Not taking action was never an option. In the Commission's
view, revising only certain parts of the regulation was not an option either.
The Commission's approach to increase patient safety is comprehensive, yet also
realistic and likely to obtain the necessary support of the European Parliament
and Council. The Commission's proposals for Regulations on Medical Devices and
In-Vitro Medical Devices took 5 years to be adopted by the European Parliament
and Council. A different proposal may not have been deemed acceptable by the

 co-legislators, and could have delayed the reform by years or even stopped it
entirely, ultimately harming our citizens and patients.
The proposal was adopted unanimously by the Council and with overwhelming
majority in the European Parliament.
Fundamental change in the legislative framework on medical devices
The review of the EU medical device system entails deep and fundamental
changes to the system. The new rules tighten controls of medical devices before
they are placed on the EU market by imposing stricter requirements for higher
risk devices, improve transparency by introducing traceability of devices and a
public database of information as well as strengthen market surveillance by
improving the functioning of notified bodies across Member States.
All operators in the field of medical devices will have to undertake a major effort
to radically change the way they work. Notified bodies, manufacturers and
medical practitioners will all be required to implement stricter safety and quality
requirements and exhibit greater transparency throughout their work. This is
even leading a number of players (industry and public authorities alike) to call on
the Commission to prolong the transitional period before starting to fully apply
the new regulations.
The Commission will continue to offer support to all operators to ensure that the
implementation of the new rules is successful in practice and delivers the high
level of safety and quality of medical devices for the patients.
On industry influence and innovation as one of the key objectives
The Commission always acts in the European interest, not in the interest of any
one group or stakeholder. In reforming the system of medical devices,
commercial interests were never prioritised over patient health.
During the legislative review on medical devices – as with any other legislative
process – the Commission was open and listened to all groups that wished to
contribute their views regarding a new system. On this basis and after
comprehensive reflection, the Commission evaluated and assessed several
available policy options. Selecting one option in the final proposal is a normal part
of any healthy and transparent legislative process, not the result of any undue
interference.
Competitiveness and industrial excellence in the field of medical devices play an
integral part in ensuring European patients can benefit from high quality devices
and healthcare. The notion that innovation is not in patients' interest is simply
misguided – it suffices to look back at the history of medical research! If properly
framed, innovation helps ensure that Europeans have access to the best quality
healthcare available worldwide.
On the effectiveness of a decentralised market authority system

 The Commission is confident that making the existing decentralised system more
robust was the best option. We have no doubt that the idea of reinforcing the
oversight of notified bodies and introducing a pre-market scrutiny for a certain
subset of high-risk devices was correctly identified as the most desirable and
sensible option. The Commission is also confident that as a result of the
Regulations, the assessment of medical devices will be done by notified bodies
fully fit for purpose. The Commission will also continue to improve the effective
monitoring of the system.
A central marketing authorisation system does not necessarily guarantee a better
protection of patients. The Commission considers that the highest level of patient
protection can be achieved by several system architectures as long as these are
robust – including a system of decentralised market approval. The claim that
devices “approved first in the EU were also associated with a nearly threefold
greater rate of safety alerts and recalls” does not necessary means that the EU
marketing authorisation system was less effective. On the contrary, it could mean
that it was very effective in detecting issues related to non-compliance with the
authorisation.
Regarding the option of extending the remit of the European Medicines Agency, it
is important to clarify the differences between medical devices and medicinal
products. Contrarily to medicines, the safety and performance of medical devices
is only possible to anticipate during the pre-market assessment to a certain
extent as the use of the device by a healthcare professional in a real healthcare
setting also plays a key role. This is why a stronger system of post-market
vigilance and surveillance is all the more important, and forms one of the key
pillars of the new Regulations.
Moreover, setting up a dedicated EU agency would have taken several years, in
particular to ensure the wide-ranging technical competences and experiences
required for the Agency to cover all concerned medical devices on the EU market.
The large timeframe required to set up an agency was therefore against the
intention of the Commission and the co-legislators to agree and implement the
changes swiftly and without delay.
On Eudamed
Eudamed will contain information on serious incident reports, field safety
corrective actions, field safety notices, periodic summary reports on serious
incidents and trend reports on non-serious incidents which will be registered by
the manufacturers (or their authorised representative) as required by the Medical
Devices Regulations. All data included in Eudamed shall also comply with the
requirements of the General Data Protection Regulation (GDPR).
In relation to access, the Regulations lay down that "the Commission shall ensure
that healthcare professionals and the public have appropriate levels of access to
the Eudamed database". While all Field Safety notices will be certainly accessible
to public, the extent to which incident reports and corrective actions are to be
accessible to the public is still under discussion with the competent authorities

 from Member States. The primary concern is protecting patients' health and their
right to transparent, complete and correct information, including in cases of
incidents with medical devices that may affect their safe usage. This requires
careful analysis of the nature and cause of any reported incident to determine
whether there is actual systemic risk for users of the affected device, or whether
there was for instance a single malfunction caused by incorrect use of a device or
other environmental factors to avoid unjustified mistrust and concerns.
On the definition of sufficient clinical evidence
The Regulation (specifically, Article 2 (51) of MDR) defines ‘clinical evidence’ as
the clinical data and clinical evaluation results pertaining to a device of a
sufficient amount and quality to allow a qualified assessment of whether the
device is safe and achieves the intended clinical benefit(s), when used as
intended by the manufacturer. The level of necessary clinical evidence depends
on the type and risk class of the device, i.e. the higher the risk class, the more
stringent the requirements. The Clinical Investigation and Evaluation Working
Group is currently drafting guidance concerning "sufficient clinical data" for the
application of Article 61 (6)(a) which is expected to be finalised in the first half of
2019.
On pre-market scrutiny
As to the number of devices subject to pre-market scrutiny, a detailed estimation
is currently being conducted. However the scoping paper produced by the
Commission's Joint Research Centre estimated provisionally between 300-500
dossiers entering the procedure per year.
On e-Commerce
The new Regulations introduce and address the problem of online sales of
medical devices. Specifically, Article 6 of the new Regulation provides a
significant legal clarification that requires that any device offered by means of
information society services to a natural or legal person established in the Union
shall comply with the Regulations. The same goes for a device that is not placed
on the market but used in the context of a commercial activity, whether in return
for payment or free of charge, for the provision of a diagnostic or therapeutic
service offered by means of information society services. This Article provides the
necessary basis to make all those concerned devices subject to the requirements
of the new Regulations, including all relevant market surveillance activities.
Finally, the introduction of the UDI system will hold a fundamental role in
supporting the fight against falsified devices.
On global comparisons
While it is too early to draw conclusions about the final implementation of the
new EU rules, it is interesting that these are already being referenced by
worldwide regulators, such as for instance Australia.

 Regarding the comparisons between the EU and US system highlighted in your
(ICIJ) questions, it should be noted that they refer to differences between the old
(now to be abolished) EU-system, and the current US system. Given the
significant overhaul undertaken in Europe, the new EU framework would be a
fairer point of comparison.
A comparison between the US and new EU legislative framework would require a
more detailed discussion. Different analyses come to different conclusions and
generally recognise that each of the two systems has specific benefits.