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 Full text 
Tuesday, 4 April 2017 - Strasbourg Revised edition

Medical devices - In vitro diagnostic medical devices (debate)

  Glenis Willmott, rapporteur. – Mr President, thank you all for your support and comments. The medical devices industry is hugely important in the EU, with over 25 000 companies employing almost 600 000 people. That is a lot of people.

Throughout our work on this legislation, we had in mind that we needed stronger rules to improve device safety and protect patients without stifling the innovation that is a key feature of the industry in Europe. I believe the agreement that we have reached strikes the right balance. This will strengthen requirements for medical devices, and require high-risk devices to undergo additional pre-market assessment. Stricter rules on post-market surveillance will also ensure a faster response if there is a problem with a device and a new ID system will improve traceability.

It is clear that Member States will have to cooperate and share information, and the new EU-wide database EUDAMED will help them do that. And importantly, patients will have more information on the devices they use or are treated with.

Unfortunately, we cannot go back in time and prevent past scandals from happening, but with this legislation, we can make them much less likely in the future. Patients rightly expect that if a device has been placed on the market, then it must be safe. But unfortunately this has not always been the case. We have a responsibility to make sure that patients can have confidence in the medical devices industry and I firmly believe that this is what the agreement we will be voting for this week will do.

Once again, thank you to everyone who has helped us to get to this stage, and again in particular to all of our staff and the Group staff, who have worked their socks off on this. I hope we have strong support in the vote tomorrow, because at the end of the day, this is about the safety of patients across the EU, and nothing can be more important than that.

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