CELEX: 51998PC0548
Language: en
Date: 1998-10-02
Title: Amended proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices

COMMISSION OF THE EUROPEAN COMMUNITIES
                                      Brussels, 02.10.1998
                                      COM(1998) 548 final
                                      95/0013 (COD)
           OPLNION OF THE COMMISSION
   pursuant to Article 189 b (2) (d) of the EC Treaty,
       on the European Parliament's amendments
    to the Council's common position regarding the
                       proposal for a
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
          on in vitro diagnostic medical devices
 AMENDING THE PROPOSAL OF THE COMMISSION
     pursuant to Article 189 a (2) of the EC Treaty
 ---pagebreak---  ---pagebreak--- 1. BACKGROUND
a)      Objective of the proposal
        The proposal for a directive, based on Article 100a of the Treaty, is intended to
        harmonise national provisions applicable to the placing on the market of in vitro
        diagnostic medical devices. It lays down the requirements to be met by the
        products with regard to protecting the health and safety of patients, users and third
        parties; the conditions governing their placing on the market and aspects
        concerning checks on products already on the market. Article 21 also provides for
        a number of amendments to Directive 93/42/EEC on medical devices, to include
        devices manufactured using human tissues in the scope of Directive 93/42/EEC,
        and to bring Directive 93/42/EEC more closely into line with the Directive on in
        vitro diagnostic devices.
b)      Date of the submission of the proposal to the Council (document COM(95)130
        final-95/0013 (COD)): 19 April 1995
c)      Opinion of the Economic and Social Committee: 25 October 1995
d)      Date of the European Parliament's opinion on first reading: 14 March 1996
e)      Date of the adoption of the common position : 23 March 1996
f)      Date of the presentation of an amended Commission proposal (document
        COM(96)643 final): 20 December 1996
g)      Commission communication to the European Parliament pursuant to Article
         189b(2) (document SEC(1998) 555 final): 26 March 1998
h)      Date of the European Parliament's decision on second reading: 18 June 1998
2.      POSITION OF THE EUROPEAN PARLIAMENT
At its plenary session in June 1998, the European Parliament adopted 6 amendments to
the Council common position. These are intended to:
        emphasise the need to notify the competent authorities of the placing on the
        market of new products, such as DNA micro-chips (amendment 1, Recital 29a)
         insist on the need for Community legislation on medical devices manufactured
         using human tissues or cells (amendment 2, Recital 33a);
         clarify that the option for Member States to demand supplementary information
         for certain medical devices is not a precondition for the placing on the market or
         putting into service of in vitro diagnostic medical devices (amendment 3, Article
          10(2), second subparagraph);
                                                2^
 ---pagebreak---       oblige manufacturers to translate the label and the instructions for use of the self-
      testing devices into one or more of the languages of the Member State where the
      in vitro diagnostic medicd device reaches its final user (amendment 4, Annex I,
      (B)(8. J), fifth paragraph a);
      oblige manufacturers to submit the tests used for evaluating the risk of trisomy 21
      (Down's Syndrome in the foetus) to certification by a third party (amendment 5,
      Annex II, List B, seventh indent a);
      emphasise, with regard to diagnosis, the primary importance of protecting the
      confidentiality of the information obtained and the principle of non-discrimination
      on the basis of the genetic characteristics of the person being examined
      (amendment 6, Article 1(4)).
3.    OPINION OF THE COMMISSION
The Commission is able to accept the amendments:
      amendment 1 because the new recital relates to the notification procedure for
      "new products" provided for under Article 10(4), and gives an important example
      of the application of that Article;
      amendment 2 because the recital recalls the need, recognised by the Member
      States, for harmonised legislation on medical devices manufactured from
      .substances of human origin. In addition to the essential pari on m vitro diagnostic
      medical devices, the Commission proposal (COM(95) 130 final) provided for the
      inclusion of devices incorporating substance:-; of human origin in the scope of
      Directive 93/42/EEC on medical devices. This pari was separated from thai
      relating to in vitro diagnostic devices and is still before the Council for a first
      reading;
      amendment 3 because it clarifies the interpretation that should be gwen to the
      procedure according to which Member Stales may request information regarding
      the labelling and the instructions for ust- of certain products. The addition is
      useful, as it prohibits supplementary national procedures other than those
      provided for in the Directive on the placing on the market of in vitro diagnostic
      medical devices.
      amendment 4 because it adds a useful clarification with regard to the extent of the
      labelling obligations for self-testing devices, in accordance with the principle
      already included in Article 4(4);
       amendment 5 because the extension of certification obligations by a third part) to
       tests designed to assess the risk of trisomy 2i (Downs Syndrome) in the foetus is
      justified, as it is necessary to ensure a very high level of quality ol'devices as false
       positive results from the tests have serious consequences for the patient and (he
       foetus;
                                                2>
 ---pagebreak---        amendment 6 because it restates the rights set out in the European Convention for
       the Protection of Human Rights and Fundamental Freedoms with regard to the
       applications of biology and medicine referred to in Article I (4).
For these reasons, and pursuant to Article 189a of the EC Treaty, the Commission has
decided to amend its proposal to incorporate the 6 amendments adopted by the European
Parliament.
                                                ^
 ---pagebreak---                           Amended proposal for a
                European Parliament and Council Directive
                   on in vitro diagnostic medical devices
(presented by the Commission pursuant to Article 189a(2) of the EC Treaty)
 ---pagebreak---  Common position of the                                   Modified proposal
                                                          Modified-proposal
          Council
                               Recital 29a (new)
                                                 {29a) Whereas it   il is essentiai_that
                                                                           essential_that
                                                 manufacturers           notify         the
                                                 conjgejgm authorities of the
                                                 placing on the market of View        'new
                                                 •products'
                                                 products' with regard both to the
                                                  technology       used        and      the
                                                  substances to behe analysed or other
                                                  parameters; this is true in
                                                  particular of high-density DNA
                                                  probe devices (known as micro-
                                                  ghiosjused In^gejieiicjiCjggnmg,
                                                                 in^gejieiiçjiCjgejùng,
                               Recital 33a (new)
                                                   (33a) Whereas it is necessary to
                                                   draw up as quickly as possible
                                                   the legislation which is lacking
                                                   on medical devices manufactured
                                                   using substances of.       of. human
                                                   origin;
                                   Article 1(4;
For the purposes of this                            For    the purposes           of     this
Directive,     the    removal,                      Directive, the removal, collection
collection and use of tissues,                      and use of tissues, cells and
ceiis and substances of                             substances of human origin shall
human      origin   shall  be                       be governed, in relation tc   to ethics,
governed, m   in relation to                        by the principles laid down in the
ethics, by the principles Said                      Convention of the Council of
down in the Convention,
                Convention of                       Europe for the protection of
the Council of Europe for the                       human rights and dignity oï       o\ the
protection of human rights                          human being with regard to the
and dignity of the human                            application      of     biology       and
being with regard to the                            medicine and by any Member
application of biology and                          States" regulations on this matte.»".
                                                    States'
medicine and by any Member                          •M                    mm^^k^É^s*!^^^
 States' regulations on this                        .?l_Jiie_ j:pnfLd?ji tïaiity__. of _ data
 matter.                                            .?l_Jiie_ j:pnfLd?ji tïaiity__. of.__ data
                                                    ^Mits.„i2_jiàyyte...JitçLJAiî4...:^
                                                    principle of non-discrimination
                                                    principle of non-discrimination
 ---pagebreak---                       on grounds of human inherited
                      genetic characteristics shall be
                      paramount.
Article 10(2), second
subparagraph (new)
                      These measures cannot constitute
                      a precondition for the placing on
                      the market and/or putting into
                      service of devices which are in
                      conformity with this Directive.
 Annex l,(B)(8.l),
 5lh subparagraph a
        (new)
                      The decision whether to translate
                      the instructions for use and the
                      label into one or more languages
                      of the European Union shall be
                      left to the Member States, except
                      that, for self-testing devices, the
                      instructions for use and the label
                      shall include a translation into the
                      official    language(s) of the
                      Member State in which the
                      device for self-testing reaches its
                      final user.
  Annex II, List B,
 7th indent a (new)
                      Reagents and reagent products,
                      including related calibrators,
                      control materials and software,
                      designed        specifically     for
                      evaluating the risk of trisomy 21.
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                          COM(98) 548 final
                                             DOCUMENTS
EN                                                             15 05 16 01
                                    Catalogue number : CB-CO-98-550-EN-C
                                                             ISBN 92-78-39453-X
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