Peter Liese: No time to lose to save human lives / I am pushing for a swift adoption of proposal in Parliament / But we need additional regulations for niche products

On Friday, the European Commission presented a proposal to amend the Medical Device Regulation (MDR). The proposal introduces a more extended transition period for adaptation to the new rules under the MDR.
"It is crucial that the European Commission has now finally proposed an amendment. We, as Christian Democrats, have been pressing Ursula von der Leyen and the Health Commissioner for months. It is a high priority as the lives of children, particularly, are at risk. Colleagues of mine who work in pediatric cardiology warn that medicine will revert to the 1950s if we do not react quickly," commented Dr. Peter Liese, health policy spokesperson for the largest group in the European Parliament (EPP-Christian Democrats).

The new deadlines depend on the risk class of the medical device and are intended to ensure that patients continue to have access to medical care. Higher-risk products, such as implants, will have a shorter transition period until December 2027 than medium- and lower-risk products, such as syringes, which will have until December 2028 for MDR certification. The amendment also eliminates a sell-out date, meaning products placed on the market under the current regulatory framework can remain on the market.

Liese explained, "The extension is subject to certain conditions, so only safe products, for which manufacturers have already taken steps to transition to the Medical Device Regulation, will benefit from the additional time. Removing the cut-off date will ensure that safe and essential medical devices already on the market remain available to healthcare systems and patients in need."
The proposal must now be adopted by the European Parliament and the Council under an accelerated co-decision procedure. "That is why I will do my utmost to ensure a timely adoption of the proposal in the European Parliament. Nevertheless, I will continue to push for additional proposals to solve the long-term problems. For certain niche products, an extension of the deadline is not enough. We need targeted regulations, such as those we have for medicines to treat pediatric diseases," said Liese.