Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-335-625"
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"en.20120614.22.4-335-625"2
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"The revision of the Medical Devices Directive must take on board the lessons learned from the PIP scandal which has affected so many women in the European Union and beyond. PIP was deliberate criminal activity but we have to recognise that the European medical devices industry has been very innovative and has helped patients a great deal, facilitating healthcare innovation and patient access to new technologies. This report calls for improved transparency, tighter control of Notified Bodies, improvements in vigilance, market surveillance and traceability of products - all are welcome. I did not support the inclusion of Paragraph 7 on the introduction of a system of pre-market authorisation. Europe already has in place an effective de-facto pre-market authorisation system and further regulation could stifle innovation. What we are trying to strike here is a balance between what is good for patients and improving the quality of life of those who need medical devices."@en1
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