Local view for "http://purl.org/linkedpolitics/eu/plenary/2017-04-04-Speech-2-399-000"
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"en.20170404.22.2-399-000"2
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"Mr President, I would like to start by thanking all my shadow rapporteurs for their excellent support and cooperation including, of course, Mr Liese, the rapporteur on IVD. My thanks to the Commission and the Council, and I would also like to thank the Luxembourg – and, in particular – Dutch Presidencies for their determination to get the Council agreement that we have today.
Colleagues, it has taken a long time and a lot of work to get to this point, so I hope you will support the final agreement as one which gives patients much more protection, while ensuring continued innovation.
We have put in place strong, clear rules for the whole life—cycle of devices, from design and manufacture through clinical testing and authorisation to vigilance and market surveillance, giving manufacturers legal certainty about what they have to do.
Protecting patients is at the heart of this legislation. We all remember the scandals of the past. I have heard from women whose lives have been turned upside down after having a pelvic mesh implant, women who are now living in constant pain. I have heard from women who are still not sure which breast implants they have had and whether they need to be worried about their future health.
It just is not right that people have not got sufficient information about devices that have been used in their medical procedures. So in future all devices will be traceable with a unique device identification number and patients will receive an implant card with this number, so we will all know which device has been implanted in which patient. If there is a problem with the device, patients deserve to be compensated, so it is clear that manufacturers must have sufficient financial coverage to deal with their potential liability.
We know that in the case of metal—on—metal hips there was little clarity for patients as to whether the problems were caused by the device or by the medical professionals treating them. When there is reason to believe a device has caused harm to a patient, information on that device must be made available to the patient and their doctor.
To ensure patient safety in the future we must make sure devices are safe before they reach the market. All devices will undergo a thorough clinical evaluation before marketing, and Parliament insisted that there should be additional scrutiny for the highest—risk devices. Things such as implants, insulin pumps and pacemakers will be referred to an expert panel for additional assessment.
Parliament also argued for restrictions on hazardous substances used in medical devices. Wherever possible, manufacturers will have to substitute materials that are carcinogenic, mutagenic or toxic to reproduction, and justify where this is not possible. Notified bodies will still have responsibility for awarding a CE mark, but it is clear that these have to be up to the job. We have introduced strict new requirements for notified bodies, and they will be regularly inspected by Member States. Notified bodies will also have greater powers to carry out unannounced inspections and must inspect samples of all devices regularly. Any problem should be picked up early and action taken straight away.
While it is vital that we ensure devices are safe before they are placed on the market, it is also essential that they are carefully monitored afterwards. The new law will significantly strengthen requirements for post-market surveillance, including introducing periodic safety update reports similar to those that are now produced for medicines.
Finally, on reprocessing of single—use devices, this was one of the most difficult issues to get agreement on. For the Member States it is a very sensitive issue. Some wanted reprocessing to be banned entirely; others wanted no legislation at EU level. Therefore, reprocessing will only be allowed if it is permitted under national law. Those Member States that want to ban it can do so. For those that allow it, there are EU-wide standards that must be complied with, including reprocessors assuming all the obligations of the manufacturers."@en1
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