51998AP0225

A4-0225/98

Decision on the common position adopted by the Council with a view to adopting a European Parliament and Council Directive on in vitro diagnostic medical devices (C4-0178/98 - 95/0013(COD))

The European Parliament,

- having regard to the common position of the Council, C4-0178/98 - 95/0013(COD),

- having regard to its opinion at first reading ((OJ C 96, 1.4.1996, p. 31.)) on the Commission proposal to the Council (COM(95)0130) ((OJ C 172, 7.7.1995, p. 21.)),

- having regard to the amended Commission proposal (COM(96)0643) ((OJ C 87, 18.3.1997, p. 9.)),

- having been consulted by the Council pursuant to Article 189b(2) of the EC Treaty,

- having regard to Rule 72 of its Rules of Procedure,

- having regard to the recommendation for second reading of the Committee on Economic and Monetary Affairs and Industrial Policy (A4-0225/98),

1. Amends the common position as follows;

2. Instructs its President to forward this decision to the Council and Commission.

(Amendment 1)

Recital 29a (new)

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>Text following EP vote>

(29a) Whereas it is essential that manufacturers notify the competent authorities of the placing on the market of 'new products' with regard both to the technology used and the substances to be analysed or other parameters; this is true in particular of high-density DNA probe devices (known as micro-chips) used in genetic screening;

(Amendment 2)

Recital 33a (new)

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(33a) Whereas it is necessary to draw up as quickly as possible the legislation which is lacking on medical devices manufactured using substances of human origin;

(Amendment 6)

Article 1(4)

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4. For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States' regulations on this matter.

>Text following EP vote>

4.

For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States' regulations on this matter. As regards diagnosis, protection of the confidentiality of data relating to private life and the principle of non-discrimination on grounds of human inherited genetic characteristics shall be paramount.

(Amendment 3)

Article 10(2), 2nd subparagraph (new)

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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.

(Amendment 4)

Annex I(B)(8.1.), 5th paragraph a (new)

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>Text following EP vote>

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 devices for self-testing, 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.

(Amendment 5)

Annex II, List B, 7th indent a (new)

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>Text following EP vote>

- Reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21.