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NOTE: A briefing note is event specific. It contains a « scene setter!> and a « line 10- ·ER>a-(
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information about the interlocutor, the context and objective(s) of the event, rl1e i.1·sues at stake and clear guida nce on
which line to take.

EVENT
(please
indicate
venue and date only on the
cover sheet)

Unit in charge : F/5, C.l

BRIEFING NOTE

Subject: revision of the medical devices legislation

1.

SCENE SETTER

CONTEXT

The existing directives covering medical devices aim to ensure the smooth functioning of
the internal market and a high level of protection of human health and safety.
Medical devices are not subject to any pre-market authorisation by a regulatory authority
but to a conformity assessment which, for medium and high risk devices, involves an
independent third party, known as 'notified body'. Notified bodies are designated and
monitored by the Member States and act under the control of the national authorities.
Once certified, devices bear the CE marking which allows them to circulate freely in the
EU/EFTA countries and Turkey. Studies have shown that this system allows for faster
market access at equivalen safety levels when compared to a pre-market authoriation
system.
The existing regulatory framework has demonstrated its merits, but has recently come
under harsh criticism, notably after the fraudulent breast implants safety case involving a
French manufacturer (PIP). Substantial divergences in the interpretation and application
of the rules that are no longer up to date and rather weak have also emerged, together
with uncertainties with regard to certain products resulting from scientific progress.
This revision aims to overcome these flaws and gaps and to further strengthen patient
safety, while being supportive of innovation and the competitiveness of the medical
device industry The proposed regulatory framework aims to allow for a cost-efficient
market access for safe, innovative medical devices, to the benefit of patients and
healthcare professionals.
POSITION OF DG ENTR

The efforts to update and strengthen the regulatory framework and therefore the safety of
medical devices are most welcome by DG ENTR. The proposal enhances the
requirements and obligations for all actors involved; manufacturers, testing laboratories
and certification bodies, national authorities and the European Commission.
1) No need for a marketing authorisation

It was decided to reinforce the current system and adapt it with a view to technical and
scientific progress,. A fundamental change to the system introducing a marketing
authorisation of medical devices was not considered appropriate. This option, which
Event - page number - version date

 would mean the transfer of responsibility for the assessment of the safety and
performance of medical devices from Notified Bodies to regulatory authorities and the
replacement of the CE marking by a marketing authorisation, was widely rejected during
the public consultations and the subsequent dialogue with competent authorities,
manufacturers and most other stakeholders.
A decentralised marketing authorisation by Member States would have a negativ impact
on the internal market for medical devices because the application of the mutual
recognition of national authorisations would not provide automatic access to the market
of the other Member States. A central marketing authorisation at EU level would require
setting up a new EU public body, with significant impact on the EU budget, on
manufacturers in terms of costs and administrative burden and on innovation in terms of
time to market. The competitiveness of EU medical devices industry would be at stake.
Furthermore, it is questionable that a marketing authorisation procedure would be able to
prevent deliberate fraudulent practices once a product is approved for marketing.
DG ENTR therefore supports the choice of reinforcing the current regime, rather than the
radical shift and associated risks for competitiveness that a marketing authorisation
would represent.

2) Aims of the proposed revision and concerns of DG ENTR

The new regulations proposed by DG SANCO are meant to:
- cover legal gaps and loopholes,
- enhance the legal clarity and coordination in the field of post-market safety,
- adapt the legal requirements, taking into account technological, scientific and
regulatory developments (for instance when it comes to classification rules),
- enhance legal certainty and coordination in the field of clinical evaluation and
investigations, in particular those conducted in more than one Member State,
- solve "borderline" cases (e.g. whether they should fall under the medical devices or the
medicinal products regulatory framework) in a cross-sectoral manner,
- provide a uniform control of Notified Bodies,
- enhance the involvement of external scientific and clinical expertise,
- clarify the obligations and responsibilities of economic operators, including in the fields
of diagnostic services and internet sales,
- enhance the transparency regarding medical devices on the EU market, including their
traceability,
- efficiently and effectively manage the regulatory system.
DG ENTR concurs that these objectives will in general be ensured by the new legislative
framework and that its tools - notably - accreditation should be used fully.
During the ISC, we nevertheless raised concerns on the:
- accreditation:
2

 The existing measures and tools of the new legislative framework that the file claims to
use are, are almost completely ignored, even though they have been approved by the
European legislators not even two years ago and accepted by market actors. The
Commission funds accreditation activities.
Especially accreditation which ensures a public authority control of notified bodies and
their regular surveillance is not taken into account.
It is clearly pointed out in the impact assessment that a large part of the problem which

could lead to the PIP scandal is the lack of resources in national ministrie and the
Commi sion to control and to properly assess notified bodies. Especially regular
surveillance visits do not seem to take place in the case of many unaccredited notified
bodies. Therefore the system proposed is developed.
In this context, the proposal can be seen as an attempt to return to a model that is tightly
controlled by the medical authorities. Accreditation bodies are already obliged to conduct
surveillance visits at regular intervals.
It is often claimed that accreditation is not specific enough for the medical devices sector

as accreditation bodies work on a wide range of sectors and subjects. However, while
accreditation is about the general technical competence of a body, an accreditation
certificate is always issued in relation to a specific activity and product.
Accreditation assessors are usually sectoral experts. European accreditation bodies are
already working on a common pool of assessors to bundle expertise. It seems doubtful
that the Commission could muster the appropriate sectoral and technical expertise to go
and assess a notified body using its own personnel.
Furthermore, there is the possibility to introduce accreditation schemes for specific
sectors if necessary. In fact, SANCO and JRC are currently developing a sector scheme
on breast cancer units. Medical devices have so far not made use of this possibility which
could greatly help in further harmonising the requirements for notified bodies.
- classification of self-medication devices that are wholly or partially absorbed by
the body under Class III products, as per rule 21.

The concern of the Association of the European Self-Medication Industry (AESOP) is
the introduction of very strict safety controls for devices that might not need them,
leading to excessive costs and bureaucratic burdens. These products are often used over a
long time and without prescription. This certainly calls for adequate security checks, but
this is also the case with a Ila classification. Otherwise, it might be more useful to only
make these devices available under supervision and with a prescription.
- timing of notification procedure, which could lead to delay the market of high-risk
devices (Class III devices).

A mechanism for scrutiny of certain conformity assessments is being proposed in the
new regulations. The notification procedure could delay the conformity assessment
process, hence the marketing of devices. It was requested to DG SANCO that this
procedure is adapted so as to not unduly introduce delays, which could be detrimental to
innovation and competitiveness, considering the time constraints imposed by competitive
markets. DG SANCO shortened some deadlines related to this procedure, which will be
in the benefit of industry and is appreciated.
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 The two final points that remained to be negotiated with DG were about the:
- introduction of a voluntary "pre-notification" of authorities by manufacturers before
envisaged class III applications in order to raise awareness of files that might be subject
to scrutiny, allowing faster reaction later on, thereby saving time
- modification of the deadline for the Medical Device Coordination Group (MCDG) to
request the summary of the preliminary conformity assessment from the notified body to
21 calendar days.
These points on the notification procedure were agreed upon between DG ENTR and DG
SANCO Cabinets.
2.

LINE TO TAKE
KEY MESSAGES (LIMITED TO THREE)

• DG ENTR welcomes the efforts to update and strengthen the regulatory framework
and therefore the safety of medical devices.
• DG ENTR supports the choice of reinforcing the current regime, rather than
introducing a new regulatory procedure for pre-market authorisation.
• DG ENTR requests that full consideration is being taken of the new legislative
framework, when it comes to accreditation .

•

Author:

Unit:
Author:-

Unit: ENTR C. I ;

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