The EU has published its proposed second corrigendum to the Medical Device Regulation, which, in a move that will come as a welcome reprieve to both manufacturers and notified bodies, proposes that the deadline for Class I devices to achieve full compliance with the Regulation be pushed back to May 26, 2024. The extra time is aimed at addressing the issue of the large volume of low-risk products — such as scalpels and forceps — that, in the absence of any exemption, would have been required to undergo notified body review for the first time.
This will benefit a wide range of devices, including reusable surgical instruments, substance-based devices, and some software. Manufacturers will now have extra time to prepare technical documentation before undergoing notified body review. The European Parliament's Committee on the Environment, Public Health and Food Safety has now voted to adopt the proposed corrigendum, which still requires wider European Parliamentary approval.