CELEX: 51993PC0241
Language: en
Date: 1993-06-01
Title: Re-examined proposal for a COUNCIL DIRECTIVE RELATING TO MEDICAL DEVICES

COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM( 93 241 final - SYN 353
                                           Brussels, 1 June 1993
                     Re-examined proposal for a
                          COUNCIL DIRECTIVE
                  RELATING TO MEDICAL DEVICES
     (presented by the Commission pursuant to Article 149.2(d)
                         of the EEC treaty)
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                         EXPLANATORY MEMORANDUM
On 21 April 1993 Parliament accepted the common position adopted by the Council on
8 February 1993 and proposed one amendment.
This proposal takes into account the amendment proposed by Parliament which the
Commission considers can be accepted in substance. The amendment will improve the
definition of the scope of the directive.
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                    Re-examined proposal for a Council Directive
                               relating to medical devices
In view of the opinion given by the European Parliament on second reading on
21 April1 concerning the proposal for a Council Directive relating to medical devices2
the Commission has decided to amend the proposal for a second time as follows :
   Common position adopted by the                   Re-examined proposal
                Council
                  ARTICLE 1(3), SECOND SUBPARAGRAPH
If, however, such a device is placed        If, however, such a device is placed
on the market in such a way that the        on the market in such a way that the
device and the medicinal product            device and the medicinal product
form a single integral unit which is        form a single integral product which
intended exclusively for use in the         is intended exclusively for use in the
given combination and which is not          given combination and which is not
reusable, that single unit product          reusable, that single product shall be
shall be governed by Directive              governed by Directive 65/65/EEC.
65/65/EEC. The relevant essential           The relevant essential requirements
requirements of Annex I of the              of Annex I of the present directive
present directive shall apply as far as     shall apply as far as safety and
safety and performance related              performance related device features
device features are concerned.              are concerned.
     Doc. PE 170 813. Not yet published.
     Common Position adopted by the Council on 8 February 1993.
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                                                                     ISSN 0254-1475
                                                               COM(93) 241 final
                                                      DOCUMENTS
EN                                                                             05
                                 Catalogue number : CB-CO-93-271-EN-C
                                                             ISBN 92-77-56206-4
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