Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-330-750"
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"en.20120614.22.4-330-750"2
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"The defective PIP breast implants scandal which broke in December 2011 revealed the lack of cooperation between Member States and the malfunction in the tracking system for medical devices. More than 400 000 breast implants from the French company PIP have been sold worldwide despite the fact that they did not comply with quality criteria. The EU must react and learn from this. A review of the legislation on medical devices is needed. Measures aimed at preventing another health scandal must be taken as quickly as possible. I should therefore like to welcome the adoption of this resolution, which calls explicitly for greater controls and market surveillance for medical devices, as well as greater information sharing between the competent national authorities in order to ensure a better level of protection for patients’ safety. We are also calling for the implementation of a number of concrete provisions such as pre-market authorisation for the most high-risk medical devices, a breast implant register and an implant recipient’s passport – measures which the Commission should now put into action."@en1
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