Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-339-000"
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"en.20120614.22.4-339-000"2
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"Following the findings by the French health authorities, the French company Poly Implant Prothèse is under investigation for the fraudulent use of industrial silicone, which is different from the material indicated in the documents submitted for conformity assessment, namely approved medical-grade silicone. The motion for a resolution adopted in Parliament today states the need to strengthen cooperation between the Member States, as well as improving ‘market surveillance, vigilance and inspection’, in order to ‘provide a better guarantee of safety of patients’ in terms of medium- and high-risk medical devices. The exchange of information between national authorities on the adverse effects of medical devices and their withdrawal from the market may improve the current framework. The resolution also proposes ‘a single European database that brings together information about the medical devices available on the market, registration of economic operations and vigilance and market surveillance initiatives’. This should not be used to favour economic interests, but rather to ensure the safety of patients, and neither should it jeopardise data protection."@en1
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