European Parliament Extends MDR Implementation Date

In a 537-3 vote, the European Parliament passed an amendment to extend the transition period for manufacturers to comply with the Medical Devices Regulation (MDR) to prevent shortages of medical devices.

The decision also endorses ending the sell-off date — the end date after which devices that have already been placed on the market and remain available for purchase — for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR).

In January, the European Commission approved a vote on the same proposal to stop thousands of medical devices from going off the market because they could not meet MDR requirements. Parliament intends to skip the customary 20-day waiting period before publishing the amendment. Instead, it will take effect immediately upon publication to help prevent a product shortage.

The transition times vary according to device class, with higher-risk devices such as implants having a shorter transition — until December 2027 —and medium and lower-risk devices such as syringes or reusable surgical instruments extended until December 2028.