Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives (COM(2005) 681 final — 2005/0263 (COD))
Date: 2006-05-17
Institutions: European Economic and Social Committee
Subjects: chemical product, marketing, medical device, occupational safety, public health, radiobiology, standardisation

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Opinion of the European Economic and Social Committee on the Proposal for a Directive of the
European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC
and Directive 98/8/EC of the European Parliament and the Council as regards the review of the
medical device directives

(COM(2005) 681 final — 2005/0263 (COD))

(2006/C 195/04)

On 2 February 2006 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 25 April 2006. The rapporteur was Mr Braghin.

At its 427th plenary session, held on 17 and 18 May 2006 (meeting of 17 May), the European Economic
and Social Committee adopted the following opinion with 128 votes in favour and one abstention.

1. Gist of the opinion

1.1
The EESC welcomes the Commission proposal, which
has long been awaited by the Member States and operators in
the sector. Its objectives may be endorsed, and the proposals
are generally sound. However, the EESC offers a number of
practical suggestions aimed at
legal
certainty, clarity, simplification and health protection.

furthering the aims of

1.2
The EESC calls for greater clarity as to which authority
is responsible for the overall evaluation in cases of a combina-
tion of medical devices, medicinal products, human blood deri-
vatives and human tissue. It also asks that a deadline be set for
the evaluation by the competent authorities, and that a guide
to the specific competences and procedures for this evaluation
be drawn up.

1.3
The EESC believes that it should be compulsory to send
information regarding registration, clinical data, certificates and
vigilance to the existing European databank, which should be
strengthened. It also asks that means be found for securing
wide circulation of non-confidential
information, not only
among the notified bodies and the competent authorities but
also among the operators concerned.

1.4
Health operators' role and responsibilities in the post-
marketing surveillance system should be made clearer, and
steps should be taken to ensure appropriate dissemination of
information and results arising from this surveillance.

1.5
The EESC appreciates the proposals regarding clinical
investigations, which relate to the safety and performance of a
device. It suggests a few changes designed to make them even
clearer, more particularly as regards the point at which clinical
research may begin, once the relevant ethics committee has

given its authorisation in accordance with the classification of
the device.

1.6
The EESC is against the exclusion of ‘reprocessing’ from
the proposed text. The re-use of medical devices designed and
produced to be used only once poses a danger to patient
health. The EESC therefore asks that the reprocessing company
be at least required to submit a set of data on the type of
operation conducted and provide similar guarantees of quality
and safety to those that apply to the original product,
informing users and patients of this.

2. Gist of the Commission proposal

Although, on the whole, the experience garnered from
2.1
implementing Directives 90/385/EEC (1)
relating to active
implantable medical devices and 93/42/EEC (2) concerning
medical devices has been positive,
legislative modification is
necessary in the interests of better implementation, both to
clarify certain existing requirements and to provide a legal basis
for planned initiatives.

2.2
Directive 93/42/EEC requires the Commission to submit
a report to the Council within five years of the implementation
date, concerning certain aspects of the functioning of the direc-
tive. The review process gave rise to a report on the func-
tioning of the Medical Devices Directives, published in June
2002. Its conclusions were taken up by the Commission in its
Communication COM (2003)386 (3), which was welcomed by
the Council in its Conclusions of December 2003 and by the
Parliament.

The communication highlighted the most

2.3
areas where improvements should be made:

important

— conformity assessment,

in particular concerning design

examination by notified bodies (4);

— the adequacy of clinical data for all classes of devices;

(1) OJ L 189, 20.7.1990.
(2) OJ L 169, 12.7.1993,

last amended by Regulation (EC) No

1882/2003 (OJ L 284, 31.10.2003).
(3) COM(2003) 386 in OJ C 96, 21.4.2004.
(4) ‘Notified bodies’ are the bodies to which manufacturers must submit
their documentation in order to receive, as appropriate, either a
certificate of conformity as
the directive, or
marketing authorisation. There may be more than one such organi-
sation per Member State and they may specialise in different areas.

required under

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— post-market surveillance, in particular for better coordina-

tion of activities;

— notified bodies, in relation to their competence for the tasks
designated to them, differences in interpretation between
them, and a lack of transparency in their performance and
in control over their activities;

3.2 Medical devices are an increasingly important health-
sector segment, with a major impact on both health and on
public healthcare spending. The provisions in the directives in
question concern over 10 000 types of product, ranging from
simple devices (such as gauze, syringes and glasses) to extre-
mely sophisticated and complex instruments (such as life-
saving implantable devices and diagnostic imaging equipment).

— and increased transparency vis à vis the general public in

relation to the assessment of devices.

The Commission began its consultation in 2003, primarily
through the Commission services' Medical Device Experts
Group (MDEG). This was followed by a public consultation
over the Internet (5).

3.3
The sector has a high technological profile, as the public
and the health authorities require ever safer and more sophisti-
cated products. It is also of major economic importance: the
European market is second only to the American, with a turn-
over of approximately EUR 55 billion, involving over 8 000
companies and some 450 000 employees.

2.4
Since the proposal deals more with regulatory clarifica-
tion than regulatory change, there are no significant economic
impacts expected. Similarly, no environmental
impacts were
identified. The Commission intends to use the proposal to
promote:

— increased clarity, to support a high level of public health

protection;

3.4
It should be noted that a large and growing number of
devices are imported into the EU. A clearer and more effective
legal framework and more open cooperation between the rele-
vant authorities could inject new life into the sector and mini-
mise the risk of losing market share and jobs.

Although the Commission rightly judges that there will
3.5
be no significant macroeconomic impact, the combined effect
of
requirements could increase costs quite
considerably for certain processes or product lines.

the additional

— greater transparency and certainty for all market players

and, in particular, the public;

3.6 Legal certainty

— an improved regulatory framework to support fast technical
the public under clearer conditions,

progress to benefit
guaranteeing safety and greater confidence.

The legal basis for the proposal is Article 95 of the EC
2.5
Treaty
(formerly Article 100A) upon which Directive
93/42/EEC is based. In order to achieve the objective of abol-
ishing technical barriers to trade and clarifying existing provi-
sions in Directives 93/42/EEC and 90/385/EEC, it is necessary
and appropriate to harmonise the laws, regulations and admin-
istrative provisions in the Member States on certain aspects
concerning the placing on the market or putting into service of
medical devices.

3. General comments

3.1
The EESC welcomes the Commission proposal, which
has long been awaited by the Member States and operators in
the sector. Its objectives are wholly laudable and the practical
proposals
should improve harmonisation in this highly
complex and diversified sector, by providing clearer, simpler
rules. The Committee does however have some reservations
and these are outlined below.

(5) This consultation took place from 11 May 2005 to 25 June 2005.

3.6.1
The proposal defines changes to be made to the
above-mentioned directives and clarifies certain implementation
procedures for other directives and regulations in cases where
it was not entirely clear which rules applied (devices incorpor-
ating a medicinal product (6), human blood derivatives (7) or
human tissue engineered products (8)). It also provides clarifica-
tion that in vitro diagnostic medical devices (9) are not covered
by the biocides directive (10), which is modified accordingly.

3.6.2
The EESC agrees with the principle that if medical
devices contain medicinal products or human blood derivatives
or human tissue engineered products ‘with action that is ancil-
lary to that of the device’, the medical devices directives should
apply. It wonders however why there is no specific mention in
the body of the regulation of tissues of animal origin, which
are mentioned in certain annexes. It also fears that the defini-
tion of ‘action ancillary to that of the device’ could give rise
once more to varying interpretations between Member States
and notified bodies, and would therefore like to see this
concept defined more precisely.

(6) Regulated by Directive 2001/83/EC in OJ L 311, 28.11.2001, as
last amended by Directive 2004/27/EC, in OJ L 136, 30.4.2004.

(7) Regulated by Directive 2002/98/EC of 23.1.2003.
(8) This refers to Regulation No 726/2004 and the proposal currently
under discussion on medicines for advanced therapies on which the
EESC has begun preparing its opinion.

(9) Directive 98/79/EC.
(10) Directive 98/8/EC in OJ L 123, 24.4.1998, as last modified by

Regulation (EC) No 1882/2003.

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3.6.3
Greater clarity is required regarding which authority is
responsible for the overall evaluation in cases of a combination
of devices incorporating medicinal substances, blood derivatives
in such cases the notified bodies may
and human tissue:
involve national or Community authorities (such as the EMEA)
which do not always have the necessary expertise to assess
medical devices as such and apply procedures designed for a
different type of product, often leading to excessively long
timeframes.

3.7.2
It believes that the proposal is lacking in terms of the
capacity of the notified bodies to carry out the tasks assigned
to them. This shortcoming was already highlighted in the 2003
communication (11). New therapeutic advances and the growing
complexity and sophistication of devices require scientific and
technical expertise that cannot always be provided at national
level. There should be a European plan or at least coordination
to ensure that certain notified bodies are specialised in certain
types of particularly complex and sophisticated products.

The EESC thinks that a deadline should be set for
3.6.3.1
the evaluation, bearing in mind that in this sector an innovative
product can very rapidly become obsolete. It also asks that a
guide be drawn up regarding the specific responsibilities and
procedures for evaluation by the competent authorities,
in
cooperation with the authorities responsible for the devices.
Lastly, on the basis of the experience which manufacturers
have built up over the years, it asks that the notified bodies be
allowed to seek a scientific opinion from any recognised
competent authority, and not just from EMEA.

The EESC agrees on the need for every non-Com-
3.7.3
munity manufacturer to designate an authorised representative
in an EU Member State to act on their behalf and to respond to
the authorities with respect to the obligations arising from this
directive. There are gaps and inconsistencies in the text,
however, and clarifications are necessary (see point 4.3 below).
In principle, the EESC is in favour of a flexible system allowing
real freedom of choice for the industry.

By their very nature, the way they act and the manu-
3.6.4
facturing techniques used, a large proportion of human tissue
engineered products are more similar to medical devices than
to drugs. In order to avoid possible legislative vacuums, the
EESC thinks that such products should come under the present
proposal, with the exception of those that act on or in the
human body by primarily pharmacological, metabolic or
immunological means.

3.7.4
The EESC believes that it should be compulsory rather
than optional to send all information relating to registration,
clinical data, certificates and vigilance (including serious unde-
sired effects and events) to the EUDAMED European databank,
which is already operating but
Its duties
should be redefined as soon as possible, in particular as regards
the provision of non-confidential
information for interested
operators, and it should be endowed with appropriate facilities
and resources.

in limited fields.

3.6.5
The EESC is against two directives (i.e. the Directive
on medical devices and the Directive on personal protective
equipment) simultaneously applying different requirements for
the shared objective of protecting the user. It could complicate
matters in practice and increase costs without bringing any
benefits in terms of safety.

3.7.4.1
A reasonable amount of non-confidential informa-
tion, in a concise form, should be made available to the stake-
holders directly concerned. Information on product safety and
quality and on post-marketing surveillance should also be made
available to health operator associations, to enable them to use
the medical devices more knowledgeably and safely.

3.6.6
The EESC welcomes the new procedure based on
comitology, added in Article 13, that paves the way for rapid,
binding decisions on issues concerning the misinterpretation of
a product as being or not being a medical device. It notes
however that for an optimal result, the flow of information
between the relevant authorities must be improved and data
managed effectively by means of the European databank.

The EESC also thinks that a guide should be drawn
3.7.4.2
up,
in cooperation with stakeholders, whereby the operators
responsible can compile and publish a summary of product
characteristics. This guide, and the information collected and
validated with respect to vigilance, should be made available to
notified bodies and competent authorities. Appropriate means
should also be found for securing wider circulation of this
information.

3.7 Information and transparency

The EESC believes that clearer and more wide-ranging
3.7.1
provisions are needed for the collection and dissemination of
information, and on coordination and communication with
regard to surveillance activities.

3.7.5
The proposal allows the instructions for use to be
provided in non-leaflet form. This is in tune with operators'
demands, particularly given the wide range of medical device
types. There should be more research into the possibilities of
using electronic instruments
(such as CD-ROMs and the
Internet), using a simpler and more flexible procedure than the
to require a qualified majority of
current one, so as not
Member States.

(11) See COM (2003) 386 of 2.7.2003, cit.

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3.7.6
The EESC thinks that the directive should explicitly
mention the MedDev guidance documents drawn up by ad hoc
working groups and issued by the Commission. Simplified
arrangements for their approval should be introduced, so as to
reduce problems of
interpretation and encourage greater
harmonisation in the practices of manufacturers and notified
bodies.

order to provide similar guarantees of quality and safety to
those that apply to the original product; at the same time, users
and patients should be clearly informed of the situation.

3.8.4
The EESC fully agrees with the clarifications proposed
for conformity assessment and the obligation to submit design
documentation for the medical device, in line with the classifi-
cation of the device and the novelty of the technology or treat-
ment involved. It also agrees on the need for the manufacturer
to apply adequate controls to any third parties it uses for
design and manufacture.

3.8 Safety

3.8.1
The post-market surveillance system is well defined in
the proposal as regards the manufacturer, but the role and
responsibilities of health operators are not made clear. The
system for disseminating information and results arising from
the surveillance mechanisms is still unsatisfactory, as it is still
too nationally-oriented and is in need of a more European
dimension.

4. Comments on specific articles

4.1 Clarity of scope

3.8.2
The EESC welcomes the changes relating to Annex X
on clinical data, concerning the safety and performance of a
device. It recommends that the article be further clarified as
regards the point at which clinical research may begin, once
the relevant ethics committee has given its authorisation in
accordance with the classification of the device.

3.8.3
The EESC is against the exclusion of ‘reprocessing’
from the proposed text. The re-use of medical devices designed
and produced to be used only once, which has already been
outlawed in certain Member States, does not provide an
adequate guarantee of patient safety, as the reliability and safety
tests that led to the authorisation of the single-use product
have not been carried out.

3.8.3.1
This is a frequent practice in hospitals in various
Member States. However, the EESC thinks that it should be
outlawed, as it poses a danger to patient health and makes it
difficult to determine liability. Sterilisation does not give a full
guarantee of safety, not least because the structural characteris-
tics of the materials used may be altered.

The EESC is aware that this is a matter of national
3.8.3.2
responsibility, but thinks that action at EU level is needed if
only because the free movement of citizens and the recent
recognition of
the possibility of receiving care in another
Member State bring a need for practices to be universally
accepted. As a transitional step, the principle could be estab-
lished that
least be
required to submit a set of data in line with the classification of
in
the medical device and the type of operation conducted,

the reprocessing company should at

4.1.1
The EESC feels that it is inconsistent with the principle
of simplification and legal certainty to apply two separate direc-
tives to the same product, as is now being proposed for
medical devices and personal protective equipment. It therefore
calls for the original text of Article 1(6) of Directive 93/42/EEC
to be re-instated.

4.1.2
Broadly speaking, the EESC feels that in the case of a
medical device which could come under the definition of other
directives (pharmaceuticals, cosmetic products, etc.), it should
be specified that when deciding the applicable directive, the
competent authorities and bodies must take account of the
principal
intended purpose of the product and the relevant
mechanism of action.

4.1.3
the EESC
In order to avoid any legal uncertainty,
thinks that section 7.4 of Annex I should be amended (Transla-
tor's note: In the English version of the Commission document, the
reference is to section 10). In particular, it should be made clear
that if a medical device contains a substance which, considered
separately, could be defined as a medicinal product,
is
covered by the specific parts of pharmaceuticals legislation
which refer to the safety and quality of the substance itself, and
not by pharmaceuticals legislation in general.

it

4.1.4
In the case of medical devices which incorporate a
product obtained through human tissue engineering, the EESC
fears that the new paragraph 4b) does not resolve the difficul-
ties of interpretation. Accordingly, the EESC would like these
products to be explicitly defined in Article 1 in accordance
with the directives in force and, in particular, with the regu-
lation currently under discussion on advanced therapy medic-
inal products (12).

(12) COM(2005) 567 final – Proposal for a Regulation of the European
Parliament and of
the Council on advanced therapy medicinal
products and amending Directive 2001/83/EC and Regulation (EC)
No 726/2004.

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4.2 Information and the European databank

4.3 Representative

4.2.1
The EESC thinks that it should be obligatory for the
various competent authorities and bodies, and for manufac-
turers or representatives, to send the relevant data, including
clinical data and reporting of serious adverse and unexpected
effects, to the EUDAMED European databank. However, for
this collection of data to be effective, it will be necessary to
redefine the duties of EUDAMED and establish an imple-
menting programme that ensures it is appropriately structured
and resourced.

In order

to ensure the completeness of

4.2.2
the data
collected, and wider dissemination of relevant non-confidential
information, the EESC thinks that a number of points in the
proposal should be modified, in particular:

— the seventh ‘whereas’ clause, so as to make centralisation of

data on clinical investigations obligatory;

— Article 10a of Directive 90/385/EEC, so as to make the
sending of information on manufacturers and representa-
tives obligatory; Article 10b of the same directive, on regu-
latory data; and Article 11(5) of that directive, on the certi-
ficates issued;

— Article 16(5) of Directive 93/42/EEC, on the certificates

issued.

4.3.1
The EESC notes an inconsistency in the definition of
the representative of a manufacturer who does not have a regis-
tered place of business in the Community.
In the 14th
‘whereas’ clause, the reference is to a single individual person
for all classes of devices, while Article 10a(3) and Article 14(2)
do not specify whether all or only some categories of device
are involved.

4.3.2
Bearing in mind the wide range of medical devices
which a manufacturer might place on the market, the EESC
calls for greater flexibility: a single representative could thus be
designated for each type of product and not necessarily for the
whole production range (while also making it clear in the
different language versions that in legal terms this refers to
both natural and legal persons).

4.4 Clinical investigations

4.4.1
Provisions on information for the competent authori-
ties to facilitate the monitoring and management of clinical
investigation data should be included in Article 2(2), and
should specify that the manufacturer or his representative must
inform the authorities of all Member States where these investi-
gations are conducted, of the suspension, interruption or end
of the investigations, with appropriate explanations.

to be
The EESC would also like Article 20(3)
4.2.3
amended, so as to enshrine the principle that non-confidential
information should be made available to users,
in summary
form, involving manufacturers and representatives as well as
the relevant authorities and bodies.

The EESC welcomes the new wording of Article 15(2)
4.4.2
and (3). However, it wonders whether it might be advisable to
specify in Article 15(3) that for Class I devices the clinical
investigations can start as soon as the relevant ethics committee
has delivered its favourable opinion on the investigation plan.

Brussels, 17 May 2006.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND