Local view for "http://purl.org/linkedpolitics/eu/plenary/2013-10-22-Speech-2-023-000"
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"en.20131022.4.2-023-000"2
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"Mr President, I would like to thank the rapporteur for the very detailed and collaborative work with the shadows. This piece of legislation affects every single citizen of Europe. I think that is an absolute fact – if not now, then certainly in the future. So it is absolutely crucial that we get it right.
I think what is of concern to us is that people did not understand how the system worked. Let us be absolutely clear: the industry works with notified bodies, and they certify the product. In theory, that should work very well, but examples have shown where it has failed us. So we are trying to improve on this position. It is a pity it takes a crisis to provoke action, but already there have been huge improvements in the system. I think it is worth stating for the record here in plenary that the Commission and the Member States have carried out joint audits of notified bodies. You have had eleven to date, and in two cases notified bodies have been asked temporarily to stop working. So when you check, you get results. That is what we are trying to do in reviewing the medical devices legislation.
I want to mention four key points: one is to strengthen special notified bodies. We are doing that, and I think it is very important with high-risk devices that only specialised notified bodies are able to certify these products. Secondly, we have an additional layer of scrutiny in particular cases where products demand that additional scrutiny, and we have details in the text. But we also need much tighter post-market surveillance, so that when a problem is detected there is feedback of that information right through the system and there is a rapid reaction to it. I think that is crucial for the effective regulation of medical devices.
Commissioner, you mentioned the issue of the reprocessing of medical devices. This is very complex, and I think we need to stick closely to the Commission proposal. However, I think we need more careful consideration of this. Some Member States ban reprocessing, others allow it; some have standards, others do not. I would ask that you come back to us with a detailed proposal on that issue in the future."@en1
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