Local view for "http://purl.org/linkedpolitics/eu/plenary/2013-10-22-Speech-2-226-000"
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"en.20131022.26.2-226-000"2
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"Madam President, this report on medical devices is a balanced one which, like the in vitro report, puts patient safety first. Recent events such as the PIP scandal and the issue of certain hip replacements causing damage to bones are clear indications that we needed to review our legislation. One of the issues which was very clear was that all the different notified bodies in the different Member States were not operating at the same high level and that such gaps in regulatory controls had to be dealt with – and they were – in this proposal.
We now have a new medical devices coordination group and the new assessment committee for medical devices. Together they will ensure that there are no gaps in the very necessary regulatory controls. The report is proportionate, and we recognise that the PIP scandal was fraud. I think we have ensured an effective streamlined authorisation process which gives certainty to manufacturers and puts patient safety first.
Like Mr Higgins, I represent a country where there are 26 000 jobs in the medical devices sector – in Athlone, Sligo, Galway and elsewhere. Today we have helped to ensure the continuation of those jobs while at the same time putting patient safety first."@en1
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