2004/389/EC: Commission Decision of 20 April 2004 on the publication of the reference of standard EN 12180:2000 "Non-active surgical implants — Body contouring implants — Specific requirements for mammary implants" in accordance with Council Directive 93/42/EEC (Text with EEA relevance) (notified under document number C(2004) 1275)
Date: 2004-04-20
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

L 120/48

EN

Official Journal of the European Union

24.4.2004

COMMISSION DECISION

of 20 April 2004

on the publication of the reference of standard EN 12180:2000 ‘Non-active surgical implants —
Body contouring implants — Specific requirements for mammary implants’ in accordance with
Council Directive 93/42/EEC

(notified under document number C(2004) 1275)

(Text with EEA relevance)

(2004/389/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 93/42/EEC of 14 June 1993
the Member States
on the approximation of
concerning medical devices (1), as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the
Council (2),

the laws of

Having regard to the opinion of the Standing Committee set up
in accordance with Article 5 of Directive 98/34/EC of the Euro-
pean Parliament and of the Council of 22 June 1998 laying
down a procedure for the provision of information in the field
of technical standards and regulations and of rules on informa-
tion society services (3), as amended by Directive 98/48/EC (4),

Whereas:

(1)

(2)

(3)

(4)

Article 2 of Directive 93/42/EEC stipulates that medical
into
devices may be placed on the market and put
service only if, when normally used,
they do not
compromise the safety of persons.

Pursuant to Article 5 of Directive 93/42/EEC, medical
devices are presumed to comply with the essential
requirements referred to in Article 3 of that Directive if
they conform to the national standards applicable to
them transposing the harmonised standards, the refer-
ence numbers of which have been published in the Offi-
cial Journal of the European Union.

Member States are required to publish the reference
numbers of national standards transposing harmonised
standards, the reference numbers of which have been
published in the Official Journal of the European Union.

EN 12180:2000 should be considered in the light of the
Commission communication ‘Communication from the
Commission on Community and national measures in
relation to breast implants (COM(2001) 666(01))’, on
the basis of which the European Commission gave CEN
a new standardisation mandate, M/320 ‘Breast Implants’,

rectifying possible

shortcomings of EN
aimed at
12180:2000. It is considered that there is a need to
improve the relationship between EN 12180:2000 and
certain essential requirements of Directive 93/42/EEC, to
facilitate compliance with clauses 7.1 and 7.5 of the
essential requirements which support General Require-
ments 1, 2 and 4.

(5)

On the basis of the information received in the frame-
work of the consultation of the members of the CEN
technical board, CEN has asked the European Commis-
sion to withdraw the citation of EN 12180:2000 from
the Official Journal of the European Communities,

HAS ADOPTED THIS DECISION

Article 1

The reference of standard EN 12180:2000 ‘Non-active surgical
implants — Body contouring implants — Specific requirements
for mammary implants’, adopted by the European Committee
For Standardisation (CEN) and published for the first time in
the Official Journal of the European Communities of 31 July 2002,
shall be withdrawn from the list of standards published in the
Official Journal of the European Communities. The standard shall
not therefore continue to confer the presumption of confor-
mity to the relevant provisions of Directive 93/42/EEC.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 20 April 2004.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 284, 31.10.2003, p. 1.
(3) OJ L 204, 21.7.1998, p. 37.
(4) OJ L 217, 5.8.1998, p. 18.