Vote is already possible in the February plenary session / Defuse the situation for the medical supply / But still a need to continue to work on long-term solutions, especially for niche products


On Tuesday, the Health and Environment Committee coordinators in the European Parliament decided to cover the Commission's proposal to amend the Medical Device Regulation (MDR) in an urgent procedure. This means the proposal could be voted on as early as the mid-February plenary session.

"It is fast now, and it has to be because human lives are at stake. For months, we have been pushing the European Commission to come up with a proposal to amend the Medical Devices Regulation - now we have it. With the urgent procedure, we could already do the final vote on it in the plenary session in February. This is essential to keep medical devices, especially devices for children, in the market," explained the health policy spokesperson of the largest group in the European Parliament (EPP-Christian Democrats), Peter Liese.

The proposal introduces a more extended transition period to adapt to the new rules under the MDR. It also aims to eliminate a sell-out date so that products placed under the current regulatory framework will remain on the market. "Still, we are not done with this issue. Regardless of this proposal, we need a long-term solution, especially for products in pediatric cardiology and pediatric surgery, where a mere deadline extension is insufficient. In medical terms: we will have to do a very quick emergency operation, but then will also have to take care of the long-term therapy of the patient Medical Devices Regulation," said the physician and MEP Liese.