During the EP plenary session (3-6 April 2017) in Strasbourg, MEPs debate on stricter rules for the certification and monitoring of medical devices, to ensure full traceability and patient safety, following recent breast and hip implant scandals. They also debate on legislation to tighten up information and ethical requirements for diagnostic medical devices, used for example in pregnancy or DNA testing. Statements by Glenis WILLMOTT (S&amp;D, UK), Rapporteur, Peter LIESE (EPP, DE), Rapporteur, Vytenis ANDRIUKAITIS, Member of the EC in charge of Health and Food Safety, Boleslaw G. PIECHA (ECR, PL), Gesine MEISSNER (ALDE, DE) and Piernicola PEDICINI (EFDD, IT).&nbsp;

Strasbourg

debate

plenary session

ANDRIUKAITIS, Vytenis (LT, EC)

medical devices (T)

WILLMOTT, Glenis (S&D, UK, Dame)

MEISSNER, Gesine (ALDE, DE)

LIESE, Peter (EPP, DE)

PIECHA, Bolesław G. (ECR, PL)

PEDICINI, Piernicola (Greens/EFA, IT)

Medical devices: extracts from the debate on the report by Peter LIESE ( EPP, DE) and Glenis WILLMOTT (S&D, UK)

https://api.multimedia.europarl.europa.eu/documents/20125/14640917/I136408Chapters%5BSD-EN%5D.srt

SOUNDBITE (English), Glenis WILLMOTT (S&amp;D, UK), Rapporteur , 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. And 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.

SOUNDBITE (English), Glenis WILLMOTT (S&amp;D, UK), Rapporteur , So in the 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. So if there's a problem with the device patients deserve to be compensated. So it is clear that manufactures have to have sufficient financial coverage to deal with their potential liability.

SOUNDBITE (German), Peter LIESE (EPP, DE), Rapporteur, When tomorrow we adopt these two reports, we will be having on the spot unannounced inspections, its not just a paper that is to be audited but also an inspection will be made of what is actually is going on, and we can pick up on the black sheep in so doing. And in the companies I think thee will be a rather different understanding if they realise at any point there somebody could turn up for an inspection.

SOUNDBITE (German), Peter LIESE (EPP, DE), Rapporteur, It isnt just for breast implants, but hip implants, stents, and items to be implanted in the brain for diagnostic tests, genetic tests, HIV tests.

SOUNDBITE (English), Vytenis ANDRIUKAITIS, Member of the EC in charge of Health and Food Safety, The Commission heartily welcomes the final compromise which contains a series of crucial improvements to the current system. Let me mention some of them: 1) strict pre-market control for high risk devices 2) reinforced criteria for designation of and oversight of notified borders 3) the inclusion of certain esthetic devices in the new legislation 4) the introduction of a new risk classification system for the diagnostic in-vitro medical devices 5)improved transparency va establishment of EU database on medical devices 6) a traceability system based on unique device identification 7) The introduction of an implant card for patients 8) stricter and more detailed rules on clinical evidence and clinical investigation 9) improved coordination mechanism between Member States for vigilance and market surveillance

SOUNDBITE (Polish), Boles&#322;aw G. PIECHA (ECR, PL), It will improve the legal framework used for medical devices and in vitro diagnostic medical devices in Europe, they will become safer and this framework will not make it difficult to make technological progress.

SOUNDBITE (German), Gesine MEISSNER (ALDE, DE), We have managed to wrap it up, it will lead to more patients safety which is good in the wake of the breast implants scandal that was the trigger after all. We won&rsquo;t have central authorisation, that&rsquo;s also a good thing because that would have stymied innovation for certain types of medical devices.

SOUNDBITE (Italian), Piernicola PEDICINI (EFDD, IT), The Five Star movement will be voting in favour of the proposals on the medical devices and the IVD (In Vitro Devices) medical devices because they go on the direction we wanted. That no low quality device will be marketed within the European Union anymore. In Europe we can&rsquo;t allow scandals anymore, such as those that we had with silicone implants or low quality HIV tests giving false negatives as Mr. LIESE said, which lead to the possibility of more AIDS being spread.