Opinion of the Commission pursuant to Article 189B(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
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 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. Date of the submission of the proposal to the Council (document COM(95)130 final-95/0013 (COD)): 19 April 1995 Opinion of the Economic and Social Committee: 25 October 1995 Date of the European Parliament's opinion on first reading: 14 March 1996 Date of the adoption of the common position : 23 March 1996 Date of the presentation of an amended Commission proposal (document COM(96)643 final): 20 December 1996 Commission communication to the European Parliament pursuant to Article 189b(2) (document SEC(1998) 555 final): 26 March 1998 b) c) d) e) f) g) 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^ 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 person being examined (amendment 6, Article 1(4)). the genetic characteristics of the basis of 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; legislation on medical devices manufactured amendment 2 because the recital recalls the need, recognised by the Member States, for harmonised 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 those it prohibits supplementary national procedures other provided for in the Directive on the placing on the market of in vitro diagnostic medical devices. than 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> 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. ^ 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) Common position of the Common position of the Council Council Modified proposal Modified-proposal Recital 29a (new) Recital 29a (new) notify notify authorities authorities {29a) Whereas il is essential_that {29a) Whereas it is essentiai_that the manufacturers the manufacturers the conjgejgm the of of conjgejgm 'new placing on the market of placing on the market of View products' with regard both to the •products' with regard both to the technology the used technology the used substances to be analysed or other substances to he analysed or other in this parameters; in this parameters; particular of high-density DNA particular of high-density DNA probe devices (known as micro- probe devices (known as micro- ghiosjused in^gejieiiçjiCjgejùng, ghiosjused In^gejieiicjiCjggnmg, true true and and is is Recital 33a (new) Recital 33a (new) Article 1(4; Article 1(4; (33a) Whereas it is necessary to (33a) Whereas it is necessary to draw up as quickly as possible draw up as quickly as possible is lacking the legislation which is lacking the legislation which on medical devices manufactured on medical devices manufactured using of. human using human of. origin; origin; substances substances and and substances substances shall shall relation relation this this the purposes of the purposes of For For Directive, removal, removal, the the Directive, collection and use of tissues, collection and use of tissues, of ceiis of ceiis be origin origin human be human governed, to to governed, m in ethics, by the principles Said ethics, by the principles Said down in the Convention, of down in the Convention of the Council of Europe for the the Council of Europe for the protection of human rights rights protection of human the human and dignity of the human and dignity of the to being with the to being with application of biology and application of biology and medicine and by any Member medicine and by any Member States' this States' this matter. matter. regulations on regulations on regard regard of of the the this this purposes purposes For For Directive, the removal, collection Directive, the removal, collection and use of tissues, cells and tissues, cells and and use of substances of human origin shall substances of human origin shall be governed, in relation tc ethics, be governed, in relation to ethics, by the principles laid down in the by the principles laid down in the Convention of the Council of Convention of the Council of the protection of the protection of Europe Europe human rights and dignity o\ the human rights and dignity oï the human being with regard to the human being with regard to the application and application and medicine and by any Member medicine and by any Member States' regulations on this matte. »". States" regulations on this matte. »". biology biology for for of of •M mm^^k^É^s*!^^^ mm^^k^É^s*!^^^ •M. ?l_Jiie_ j:pnfLd?ji tïaiity__. of _ data. ?l_Jiie_ j:pnfLd?ji tïaiity__. of. __ data ^Mits. „i2_jiàyyte. JitçLJAiî4. :^ principle of non-discrimination principle of non-discrimination Article 10(2), second subparagraph (new) Annex l,(B)(8. l), 5lh subparagraph a (new) Annex II, List B, 7th indent a (new) on grounds of human inherited genetic characteristics shall be paramount. 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. 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 the official language(s) Member State the device for self-testing reaches its final user. of in which Reagents and reagent products, including calibrators, related control materials and software, designed for evaluating the risk of trisomy 21. specifically 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 Office for Official Publications of the European Communities L-2985 Luxembourg %