9
Oct
2024
Watch
Urgent need to revise the Medical Devices Regulation (debate)
Madam President, Commissioner, ladies and gentlemen, ladies and gentlemen! There is no longer any doubt that the Medical Devices Regulation was well-intentioned but badly done. It has to be changed and it has to happen very, very quickly. We've lost a lot, a lot of valuable time. We here in the European Parliament have been beating for almost three years – almost three years! – Alarm. The first changes to the Medical Devices Regulation were good. But they are not enough. The situation, as many colleagues have mentioned, is still dramatic. The European medical device manufacturers leave our European Union, the applications are now made to the FDA in the USA and no longer to us in Europe. This is actually a big scandal. I also say that when you go to hospitals, when you listen to the medical profession, when you ask the certified bodies, they all say: It doesn't go on like this. I really ask the new Commission to present a proposal immediately, not to evaluate it first. We've lost three years now. We need an accelerated approval process for innovative medical devices. The recertification of low-risk products for every five years must be abolished. We also need to abolish the certification of niche products.