CELEX: 51990PC0247
Language: en
Date: 1990-06-14
Title: RE-EXAMINED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES

COMMISSION OF THE EUROPEAN COMMUNITIES
                                         COM(90) 247 f i n a l - SYN 173
                                         Brussels, 14 j u n e 1990
                      Re-examined proposal for a
                           COUNCIL DIRECTIVE
   on the approximation of the lavs of the Member States
       relating to aotive implantable medical devices
                  COM ( 8 8 ) 717 f i n a l SYN 173
                            COM ( 8 9 ) 418
      (presented by the Commission pursuant to A r t i c l e  149.2(d)
                          of the EEC t r e a t y )
 ---pagebreak---                       Explanatory Memorandum
The proposal Directive (COM (88) 717 final SYN 173), which is
based on Article 100 A of the EEC Treaty, was sent to the Council
on 22 December 1988.
Parliament delivered its opinion on the proposal at its
session of 12 April 1989. As a result of this opinion, the
Commission amended its proposal (see COM (89) 418) to take
account of the changes suggested by Parliament.
On 22 February 1990, the Council adopted a common position with a
view to the adoption of a Directive on the approximation of the
laws of the Member States relating to active medical devices.
This Common Position was sent to the Parliament which adopted 4
amendments at its session of May 1990.
Pursuant to paragraph (2) d) of Article 149 of EEC Treaty the
Commission re-examined its proposal and decided to accept 3 of
the 4 amendments and to refuse one of these amendments for the
reasons given in annex.
This re-examined proposal takes into account the amendments which
the Commission considers as acceptable.
 ---pagebreak---            RE-EXAMINED PROPOSAL £Q£ A CQÏÏNGIL DIRECTIVE
      on the approximation of the laws of the Member States
          relating to active implantable medical devices
The Commission approves the Common Position of the Council
countained in document 4071/90 of February 23, 1990, subject to
the following amendments :
1.    AMENDMENT OF ARTICLE 10 PARAGRAPHS 1 AND 2
"1. In the case of devices intended for clinical investigations,
the manufacturer or his authorized representative established in
the Community shall, at least forty-five days before the
commencement fo the investigations, submit the statement referred
to in Annex 6 to the competent authorities of the Member State in
which the investigations are to be conducted.
2. The manufacturer may commence the relevant clinical
investigations at the end of a period of forty-five days after
notification, unless the competent authorities have notified him
within that period of a decision to the contrary, based on
considerations of public health or public order."
2.    ADDITION OF A NEW PARAGRAPH 4 TO THE ARTICLE 11
"4. The notified body and the manufacturer or his authorized
representative established within the Community shall agree on
the time-limits for the completion of the evaluation and
verification operations referred to in Annexes 2 to 5."
3.    AMENDMENT OF ARTICLE 16, PARAGRAPH 3
"3. Member States permit for the period up to 31 December 1994,
the placing on the market and putting into service of devices
complying with national rules in force in their territory on 31
December 1992."
 ---pagebreak---                               ANNEX
                     REMARKS ON THE AMENDMENT
             WHICH WAS NOT ACCEPTED BY THE COMMISSION
Amendment n° 4
Annex 6, Point 2.2., introductory phrase
Common Position of the Council     —Text amended by Parliament"-
"2.2. For devices intended for     "2.2. For devices intended for
clinical investigations           clinical investigations :"
covered in Annex 7 :M
Opinion of the Commission
The Commission cannot accept this amendement for the following
reasons :
This amendment referring to Annex 6 of the Common Position and
regarding the deletion of the reference to Annex 7 aims according
to the report of the European Parliament - at eliminating
small scale clinical investigations from the provisions of Annex
7 of the Directive.
The Commission considers that the provisions of Annex 7 and
particularly those of points 2.2. and 2.3 should remain
applicable whether the clinical investigations are small or large
scale.
 ---pagebreak---                                                                                 ISSN 0254-1475
                                                                 COM(90) 247 final
                                                      DOCUMENTS
EN                                                                                       05 06
                                  Catalogue number : CB-CO-90-265-EN-C
                                                               ISBN 92-77-61022-0
PRICE                         1 - 30 pages: 3.50 ECU     per additional 10 pages: 1.25 ECU
Office for Official Publications of the European Communities
L-2985 Luxembourg