Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Date: 2001-12-07
Institutions: Council of the European Union, European Parliament
Subjects: medical device, medicinal product, public health

L 6/50

EN

Official Journal of the European Communities

10.1.2002

DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Council Directive 93/42/EEC concerning medical devices

of 7 December 2001

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(b) point (e) shall be replaced by the following:

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social
Committee,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (1),

Whereas:

(1)

(2)

(3)

This Directive aims at including in the scope of Directive
93/42/EEC (2) only medical devices which incorporate,
as an integral part, substances derived from human
blood or human plasma. Medical devices incorporating
other substances derived from human tissues remain
excluded from the scope of the said Directive.

The essential aim of any rules governing the production,
distribution or use of medical devices must be to safe-
guard public health.

National provisions for the safety and health protection
of patients, users and, where appropriate, other persons,
with regard to the use of medical devices should be
harmonised in order to guarantee free movement of
such devices within the internal market,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Article 1(5) of Directive 93/42/EEC is hereby amended as
follows:

(a) point (c) shall be replaced by the following:

‘(c) medicinal products covered by Directive 65/65/EEC,
including medicinal products derived from blood as
covered by Directive 89/381/EEC;’;

(1) Opinion of the European Parliament delivered on 23 October 2001
(not yet published in the Official Journal) and Council Decision of 3
December 2001.

(2) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Directive
2000/70/EC of the European Parliament and of the Council (OJ L
313, 13.12.2000, p. 22).

‘(e) human blood, blood products, plasma or blood cells of
human origin or to devices which incorporate at the
time of placing on the market such blood products,
plasma or cells, with the exception of devices referred
to in paragraph 4a;’.

Article 2

Implementation, transitional provisions

1.
Before 13 December 2001, Member States shall adopt
and publish the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall immediately
inform the Commission thereof.

Member States shall apply these measures with effect from 13
June 2002.

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field governed by this Directive.

3. Member States shall take the necessary action to ensure
that the notified bodies which are responsible pursuant to
Article 16 of Directive 93/42/EEC for conformity assessment
take account of all relevant information regarding the charac-
teristics and performance of devices incorporating stable deriv-
atives of human blood or human plasma, including in partic-
ular the results of any pertinent tests and verification already
carried out under the pre-existing national law, regulations or
administrative provisions in respect of such devices.

4.
For a period of five years following the entry into force of
this Directive, Member States shall accept the placing on the
market of devices incorporating stable derivatives of human
blood or human plasma which conform to the rules in force in
their territory on the date on which this Directive enters into
force. For a further period of two years, the said devices may be
put into service.

10.1.2002

EN

Official Journal of the European Communities

L 6/51

This Directive shall enter into force on the date of its publication in the Official Journal of the European
Communities.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 7 December 2001.

For the European Parliament

The President

N. FONTAINE

For the Council

The President

I. DURANT