EU Extends Compliance Date for Medical Devices Regulation

The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”

The Commission has also removed the “sell-off” date — the end date after which devices that have already been placed on the market and remain available for purchase should be withdrawn. Removing the sell-off date will “ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need,” the Commission said.

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.

The extension applies only to legacy devices, such as pacemakers or syringes, covered by a certificate or declaration of conformity issued prior to May 26, 2021.