Amendments to the Medical Devices Regulation adopted
The European Parliament voted positively on the draft amendment to the Medical Device Regulation (MDR). Since the Council already gave its approval at the end of January, the amendment has now been de facto adopted. Manufacturers are thus given more time to transfer existing products to the MDR.
Conditions for the extensionThe extension is subject to certain conditions. That means more time will only be granted for products that are safe and for which manufacturers have already taken steps to transition to MDR: The application must be submitted no later than May 26, 2024, and the contractual agreement with the Notified Bodies must be concluded no later than September 26, 2024.
Also, the sales deadline for existing devices previously specified in the Medical Devices Regulation (MDR Art. 120(4)) and the In Vitro Diagnostics Regulation (IVDR) Art. 110(4) has been abolished to allow medical devices already on the market to be made available beyond the end date of May 2025.