Local view for "http://purl.org/linkedpolitics/eu/plenary/2013-10-22-Speech-2-232-718"
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"en.20131022.26.2-232-718"2
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"I supported Parliament’s amendments to the proposed medical devices regulation. Over 3 500 people in Ireland were fitted with defective metal hip replacements between 2003 and 2010 while more than 1 500 women in Ireland received faulty PIP breast implants, containing industrial silicone instead of medical-grade fillers. Hundreds of thousands more have been similarly affected across Europe. These faulty medical devices then have to be replaced, causing additional distress to patients. We clearly need a better Europe-wide regulatory framework for medical devices, one that guarantees that only devices that are safe for patients are authorised, and that promotes safe innovation in this sector. We need a state-of-the-art assessment procedure for all medical devices – from hip and breast implants to surgical instruments, as well as reinforced controls over the 80 or so ‘notified bodies’ across Europe which are responsible for assessing the performance and safety of medical devices, and which should operate to common standards. I would now urge the Council to work closely with Parliament so that we can reach overall agreement on a new regulation and reassure the public concerning the safety of medical devices used across Europe."@en1
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