DRAFT

EN

Committee on Medical Devices

Set up by

Directive 90/385/EEC on Active Implantable Medical Devices

Report to the European Parliament

Meeting of February 26th 2003

Subject:Opinion on a draft Commission Directive of [...] introducing detailed specifications as regards the requirements laid down in Directive 93/42/EEC with respect to medical devices utilising tissues of animal origin

Report to the European Parliament

Committee on Medical Devices

Meeting of February 26th 2003

Opening of the meeting

The chair opened the meeting and announced to participants that information about the meeting participants’ credentials was available and could be consulted.

The Chair informed participants that for this Committee meeting the provision concerning the weighting of votes was as described in article 205, paragraph 2 of the Treaty of Amsterdam.

Participants

The Chair drew up the list of participants, attached hereto (Annex I).

Agenda and minutes

The Committee approved the agenda as follows:

  1. Revision of the “Rules of Procedure”
  2. Opinion on a draft “Commission Directive introducing detailed specifications as regards the requirements laid down in Directive 93/42/EEC with respect to medical devices utilising tissues of animal origin”.

The Committee also approved the minutes of the written procedure of November 11th 2002, in relation to the opinion on a draft “Commission Directive on Reclassification of Breast Implants”, and the minutes of the Committee meeting of December 5th 2001.

1.Revision of the Rules of Procedure

The Chair introduced the document, which was based on the standard rules of procedure document, as approved by the Commission in accordance with the Council Decision 1999/468/EC.

The Chair drew participants attention to article 6 on “representation and quorum”, for which a new wording was proposed. Member States unanimously accepted to discuss this new wording. The proposal itself was unanimously approved (85 votes).

Member States noticed that in article 2 there was no reference to Directive 90/385/EEC, and invited the Commission to propose a suitable text.

The Chair submitted the Committee a proposal for a new paragraph. Member States unanimously accepted to discuss the proposal. This amendment was unanimously approved (85 votes).

The Chair proceeded to a vote on the document in its entirety.

The draft text on the “Rules of Procedure” was adopted (Annex II).

2.Opinion on a draft Commission Directive of [...] introducing detailed specifications as regards the requirements laid down in Directive 93/42/EEC with respect to medical devices utilising tissues of animal origin.

A debate took place where all Member States intervened.

The Commission was informed about some linguistic and typographical errors. France, Spain and Sweden submitted their linguistic comments. The Chair said that it would contact the Commission jurist linguists to deal with this matter.

The Committee discussed a document circulated by the Belgian authorities on article 1 point 4 of the proposal, intending to clarify that extra corporal systems are covered by the proposed Directive. Member States agreed with this interpretation and requested it to be recorded in the minutes. It was also agreed that this subject should be dealt with in Guideline documents.

The Chair proceeded to a vote.

He took note that the Committee had issued a favourable opinion (Annex III) on the draft measures submitted (Annex IV), by 75 votes in favour and10 abstentions.

Annex I

Committee on Medical Devices

Regulatory Committee Meeting of 26 February 2003 – Article 7 Committee

European Officials and Committee Representatives : Attendance List

Commission / European Officials
Antonio Lacerda De Queiroz – Acting Chair
Cornelis Brekelmans
Karen Howes
Marbellyz Roa Cermeno
Michel Vitucci
Sarah Onians
Member States / Committee Delegates
Belgium / Philippe Bauwin
Els Geeraerts
Denmark / Helle Sandager- Jorgensen
Germany / Dr Mientus
Greece / Theodore Ktenas
Nicolas Pallikarakis
Spain / Carmen Abad Luna
France / Jean-Claude Ghislain
Ireland / Wilf Higgins
Ann O’Connor
Italy / Emilio Federeci
The Netherlands / Ancko de Vries
Jos Kraus
Austria / Wolfgang Ecker
Portugal / Dr. Heitor Costa
Finland / Martti Rissanen
Petri Pommelin
Sweden / Lars Johansson
Gert Bruse
United Kingdom / Steve Owen

Annex III

Opinion

The Committee on Medical Devices (Article 7 Committee), meeting in Brussels on February 26th 2003, in accordance with the provisions as laid down in Article 205 of the Treaty, gave its favourable opinion to the draft. “Commission Directive introducing detailed specification as regards the requirements laid down in Directive 93/42/EEC with respect to medical devices utilising tissues of animal origin”.