Proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma
Date: 2001-08-22
Institutions: European Commission
Subjects: blood transfusion, disease prevention, free movement of goods, health policy, product safety, public health

C 304 E/334

EN

Official Journal of the European Communities

30.10.2001

Proposal for a Directive of the European Parliament and of the Council amending Council
Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incor-
porating stable derivates of human blood or human plasma

(2001/C 304 E/24)

(Text with EEA relevance)

COM(2001) 480 final (cid:151) 2001/0186(COD)

(Submitted by the Commission on 22 August 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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
Committee,

the Economic and Social

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

Whereas:

(1) The Directive aims at amending Directive 93/42/EEC as
amended by Directive 2000/70/EC, so as to include in its
scope only devices which incorporate, as an integral part,
substances derived from human blood or plasma. However,
medical devices incorporating other substances derived
from human tissues remain excluded from the scope of
the said Directive.

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

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

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 93/42/EEC, as amended by Directive 2000/70/EC, is
hereby amended as follows:

Article 1 shall be amended as follows

(a)

in paragraph 5, point (c) shall be replaced by the following:
medicinal products
covered by Directive 65/65/EEC,
including medicinal products derived from blood as
covered by Directive 89/381/EEC.

(b) in paragraph 5, point (e) shall be replaced by the following:
human blood, blood products, plasma or blood cells of
human origin or to devices which incorporate at
the
such blood products,
time of placing on the market

plasma or cells, with the exception of devices referred to
in Article 1(4a).

Article 2

Implementation, transitional provisions

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive before 13 December 2001. 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
their official publication. The
reference on the occasion of
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 domestic law which they adopt
in the field governed by this Directive.

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

this Directive, Member States

During a period of five years following the entry into
4.
force of
the
placing on the market of such 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.

shall accept

Article 3

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

Article 4

This Directive is addressed to the Member States.