EU Commission extends MDR deadlines
The EU Commission announced in early January that it would provide more time for the certification of medical devices to reduce the risk of bottlenecks. The proposal introduces a longer transition period for adaptation to the new regulations, as provided for in the Medical Device Regulation (MDR). 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 devices. In addition, medical devices that were placed on the market under the current regulatory framework and are still available can remain on the market beyond 26 May 2024.
"The availability of safe medical devices for European patients is our priority. This proposal does not change the current safety and performance requirements of the Medical Devices Regulation. It only amends the transitional provisions to give manufacturers more time to switch from the previously applicable rules to the new requirements of the Regulation," said a statement from the Commission. The length of the proposed extension of the transition periods would depend on the type of product: a shorter transition period (until December 2027) would apply to higher-risk products, such as pacemakers and hip implants, than to medium- and lower-risk products, such as syringes or reusable surgical instruments (until December 2028).
The proposal now has to be adopted by the European Parliament and the Council under an accelerated procedure. The German Medical Technology Association (BVMed) sees this as a good signal for medical care for patients and for Europe as a location for medical devices. "It is good that the Commission is now setting the pace. Now, an agreement with the Parliament and the Council must be reached in a fast-track procedure in order to ensure, on the one hand, that patients throughout Europe have access to safe medical devices and, on the other hand, to give the medtech industry the necessary planning security," says BVMed Managing Director Marc-Pierre Möll.
