Proposal in the first 100 days of new Commission expected
The biggest group in the European Parliament (EPP Christian Democrats) demands an urgent review of the Medical Device Regulation. “The Regulation was not only well intended but it was also necessary due to a lot of scandals, including the PIP breast implant scandal. It is good that we have unannounced controls, a better surveillance of the notified bodies, and some other improvements. But, unfortunately, we have to clearly see that the EU institutions exaggerated and that there is a lot of red tape that does not really add safety but hinders the production of very much needed medical devices, like for example cardiac catheters for children,” explained Dr. Peter Liese, spokesperson of the EPP in the Committee for Environment and Health, and Tomislav Sokol, spokesperson in the Subcommittee on Health.
The Parliament will adopt a resolution in its meeting in Strasbourg on Wednesday. This is to put pressure on the European Commission to propose a revision. “If we start to evaluate again, we lose additional years, and that is time we do not have,” stressed Sokol. The EPP group demands that a concrete proposal, which abolishes unnecessary bureaucracy and safeguards supply of important medical devices, in particular for children, should be presented by the Commission in the first 100 days after taking over office. Peter Liese had already developed a concrete legal proposal together with the legal expert Erik Vollebregt. “This is a targeted proposal. Its intention is to fix things, to make the regulation just right,” explained Vollebregt. “All the elements are on the table for many months now and the Commission really needs to speed up its work. It is important that we give a signal to reduce bureaucracy and increase competitiveness during the first 100 days and the Commission is rightly intending to do so. But peoples’ health, in particular children’s health, is even more important. That is why we are really tough on this demand,” emphasized Liese.