Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-334-750"

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"en.20120614.22.4-334-750"2
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"The motion for a resolution on defective silicone gel breast implants made by French company PIP, for which I was a specialist on behalf of the Group of the European People’s Party (Christian Democrats), was adopted by a large majority in the June part-session. I welcome this move. The main objectives of this resolution were to reinforce and harmonise authorisation criteria and the role of notified bodies, particularly with regard to controls, to improve supervision by competent national authorities of notified bodies, but also to make the public more aware of the health risks associated with the use of medical devices. Furthermore, in this resolution the Members of Parliament, all of the political groups together, are recommending the reinforcement of market surveillance and vigilance. This resolution has enjoyed the general support of all of the political groups. Unfortunately, the paragraphs referring to the implementation of market authorisation for medical devices of class IIb and III have been adopted (paragraphs 7 and 16). My fellow Members in the other political groups have not realised that such a system would be totally inappropriate given the nature and commercial life of medical devices. Medical devices cannot be compared to medicines."@en1

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