Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-334-000"

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"en.20120614.22.4-334-000"2
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"The resolution on PIP is in general a positive one except where Parliament, by a small majority, voted to ask the Commission ‘to shift to a system of pre-market authorisation for medical devices of certain classes’. This makes no sense, as we already have pre-market authorisation in place for these medical devices. The PIP case has nothing – I repeat, nothing – to do with authorisation; it concerns fraud. It shows up a weakness in the process where the competent authorities did not exercise adequate controls. The problem is with market control, not with authorisation. Parliament missed the target on this one, but I was very pleased to hear Commissioner Dalli’s words to the effect that he fully recognised that the PIP case was one where the competent authorities were not consistently vigilant in regard to patient safety, and this case had nothing to do with pre-market authorisation."@en1
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