Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-02-13-Speech-4-036"
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"en.20030213.3.4-036"2
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". – Mr President, I would like to start by congratulating Mrs Stihler and the members of the Committee on the Environment, Public Health and Consumer Policy for their excellent work. The same applies to the members of the Committees on Petitions and Women's Rights and Equal Opportunities who also played a part in the process.
The report reflects the policy consensus between the European Parliament and the Commission. I am pleased to inform Parliament that, last week, the Commission adopted a directive reclassifying breast implants in the context of the legislation on medical devices. Breast implants are now subject to the most stringent assessment procedures. More precisely, breast implants have been reclassified from class IIB to class III. It requires, in addition, clinical data and design attributes, namely on biocompatibility, physical and mechanical properties. This will increase the level of safety of breast implants.
Furthermore, at the request of the Commission and the Member States, CEN, the European Standardisation Body, is proceeding to an in-depth review of the European standards on breast implants.
The Commission received encouraging information from Member States regarding national measures taken, or further developed, under the recommendations set out in our communication of November 2001. This information will be made available to Parliament in a Commission staff working document on national measures adopted or planned to be adopted by Member States in relation to breast implants. This paper will be finalised in the coming weeks.
The Commission believes that its communication and the production of the forthcoming working document have produced a significant effect. All Member States have acted by verifying existing national policies and by starting to introduce measures as recommended by the communication. Both documents will continue to be a useful element that interest groups and national authorities may use, at national level, to promote best practice and inspire further actions.
The excellent cooperation between Parliament and the Commission on this subject should be highlighted, since the overall result has been extremely positive."@en1
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