Local view for "http://purl.org/linkedpolitics/eu/plenary/2014-04-03-Speech-4-223-317"
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"en.20140403.82.4-223-317"2
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"In light of the breast implant and hip replacement scandals in recent years, I believe that the Commission and Parliament had to act to ensure all medical devices placed on the European market are safe for patients and health professionals to use and to restore public confidence in the EU’s capacity to regulate the use of medical devices. I am therefore broadly supportive of measures towards achieving this goal. For instance, reinforcing public access to clinical data for both patients and health professionals can spur innovation, in which companies like Amtec Medical in my own constituency are already leading the way. The proposals could also allow patients, professionals and stakeholders to make more informed choices regarding the medical devices they use. Nevertheless I am concerned by the centralised EU approach in which ‘special’ notified bodies overseen by the European Medicines Agency (EMA) will simply duplicate pre-market assessments. Given the EMA is under financial constraints I remain to be convinced that it will adequately cope with these new responsibilities. I am also concerned that medical devices will be reused by default unless they are included in an approved list drawn up by the Commission. I therefore chose to abstain."@en1
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