Council Conclusions on 2 December 2003 on Medical Devices
Date: 2003-12-02
Institutions: Council of the European Union
Subjects: harmonisation of standards, international standard, medical device, public health

24.1.2004

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Official Journal of the European Union

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(Information)

COUNCIL

COUNCIL CONCLUSIONS

on 2 December 2003

on Medical Devices

(2004/C 20/01)

THE COUNCIL OF THE EUROPEAN UNION,

essential elements with a view to the proper implemen-
tation of Directive 93/42/EEC on medical devices;

1. RECALLS the Council Conclusions of 26 June 2002 on the

role of medical devices;

2. ACKNOWLEDGES:

— the importance that the EU continues to play a leading
role in the field of international regulatory convergence
regulatory practice, and is part of global
and best
initiatives such as global vigilance and a global nomen-
clature for medical devices;

— the importance of medical devices in health and social
care and for improving the level of health protection as
well as the fact that medical devices today account for
an ever increasing share of public health expenditure;

3. WELCOMES:

— that

the Directives 90/385/EEC (1), 93/42/EEC (2) and
98/79/EC (3), subject to amendment of some of their
provisions, constitute an appropriate legal
framework
for the placing on the market and putting into service
of medical devices, and in general provide appropriate
guarantees for protecting health whilst allowing access
to new technology to the benefit of European citizens,
patients and users;

— that the correct implementation of this legal framework,
the use of the various instruments which it provides to
address specific issues, and the concomitant availability
resources at both Community and
of appropriate
national
importance for the
protection of safety of citizens, patients and users;

level are of paramount

— the Commission's Communication on Medical Devices

of July 2, 2003;

— the launch of a study on innovation, public health
impact and competitiveness and the Commission's
the
intention to examine
to promote
Community's Public Health Programme,
health aspects in relation to medical devices;

the possibilities, under

— the Commission's

intention to promote

enhanced
consultation and coordination between the national
authorities and the Commission, alongside the Medical
Devices Experts Group;

— that in particular, the designation and monitoring of
Notified
of
conformity assessment procedures and, as need be, the
reclassification of particular medical devices, constitute

implementation

Bodies,

correct

the

— the Commission's announcement that it will present a
proposal
amending Directives
directive
the main
90/385/EEC and 93/42/EEC in respect of
areas as identified in the Commission's Communication;

for

a

(1) Council Directive 90/385/EEC of 20 June 1990 on the approxi-
the Member States relating to active

mation of
implantable medical devices (OJ L 189, 20.7.1990, p. 17).

the laws of

(2) Council Directive 93/42/EEC of 14 June 1993 concerning medical

devices (OJ L 169, 12.7.1993, p. 1).

(3) Directive 98/79/EC of the European Parliament and of the Council
of 27 October 1998 on in vitro diagnostic medical devices (OJ L
331, 7.12.1998, p. 1).

4. UNDERLINES that implementation of the legal

framework
has to be improved by all parties concerned, in particular
as regards conformity assessments, including the need for
manufacturers to provide appropriate clinical and laboratory
data as part of the technical file;

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5. ENDORSES:

— the various initiatives announced in the Communication
in order to increase transparency and trust in relation to
the placing on the market and putting into use of
medical devices;

intended

— the working programmes attached to the Communi-
as
improve
cation
presented by the Commission, in particular in relation
to market
clinical
evaluation, and regulatory clarification;

surveillance, Notified

implementation,

Bodies,

to

— the Commission's intention to carry out within 5 years a
the working programmes

the impact of

review of
announced in the Communication;

6.

to actively engage in the
INVITES the Member States
reporting of
information as requested by the Directive
93/42/EEC on medical devices in relation to the consul-

tation mechanisms foreseen in those cases where medical
contain medicinal products or human blood
devices
derivatives, clinical
investigation and vigilance, allowing
complete and consistent data to be made available for
analysis in conformity with the provisions of the Directive;

7.

INVITES THE COMMISSION AND THE MEMBER STATES:

— to set up and maintain the European Database for
Medical Devices and, as a basis for the database, to
start
the Global Medical Devices
Nomenclature;

implementation of

— to strengthen coordination between the Commission
and the national authorities in charge of implementing
to ensure a consistent and
the directives
the
coherent
directives and to achieve greater efficiency in the
interest of protecting public health.

interpretation and implementation of

in order

COUNCIL RESOLUTION

of 2 December 2003

on pharmaceuticals and public Health challenges — focusing on the patients

(2004/C 20/02)

THE COUNCIL OF THE EUROPEAN UNION

1. RECALLS the Council Conclusions on Medicinal Products
and Public Health of 29 June 2000 (1), which stress the
need for greater actions in the area of added therapeutic
value,
rational use of medicines and information to
patients;

2. CONSIDERS that the 14 recommendations of the ‘G10 High
Level Group on innovation and provision of medicines’,
contained in its Report of March 2002, are designed to
contribute to both industrial competitiveness and public
health goals and HIGHLIGHTS in particular the recommen-
dations that call for better information to patients and the
systems for pharmacovigilance and
need for stronger
relative effectiveness within Member States;

3. WELCOMES the Commission communication entitled ‘A
stronger European based pharmaceutical Industry for the
benefit of the patient’ in response to the above-mentioned
14 recommendations of the G10 Medicines Group and

TAKES NOTE of the ‘G10 Medicines Conference’, held in
Rome on 10 and 11 July 2003;

4. RECALLS the Council Conclusions of 22 September 2003
on ‘Reinforcing the competitiveness of the European-based
industry’ (2); REAFFIRMS the need for a
pharmaceutical
and public health
balance between competitiveness
policies; and RECOGNISES the contribution and importance
of a strong and competitive pharmaceutical
industry in
Europe to the improvement of public health;

5. RECALLS the common positions on the review of

the
Community legislation on pharmaceuticals adopted by
the Council on 29 September 2003, and the importance
of the review for achieving some of the goals set out in the
G10 recommendations;

6. STRESSES the importance of monitoring the impact of EU
enlargement for the health systems in the Member States
and Acceding States, especially due to free movement of
the
people and products, and NOTES in this context
Declaration of the Ministers of Health of the Acceding
Countries signed in Milan on 5 September 2003;

(1) OJ C 218, 31.7.2000, p. 10.

(2) OJ C 250, 18.10.2003, p. 1.