Medical Device Regulation

The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application.

To access legacy devices’ extended timelines, by May 2024 manufacturers must have implemented an MDR compliant QMS and have applied to a Notified Body for a Conformity Assessment. By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. On the same date, up-classified legacy devices (whose Declaration of Conformity was signed by 26 May 2021) now requiring Notified Body involvement must be MDR certified. All legacy devices must be MDR compliant by the end of December 2028.

The sell-off period for medical devices already placed on the market under MDD and AIMDD has been removed. These devices can be made further available on the market without legal time restrictions.

For detailed information and conditions of applicability of transitional provisions, please refer to the Regulation amending (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices published in March 2023.