MDR TRANSITION TIMELINE

The MDR became applicable on May 26th, 2021. This means that from that date onwards, certification of new medical devices will no longer be granted under the MDD or AIMDD – and they may only receive the CE mark under the MDR.

Regarding existing medical devices – their certificates will remain valid throughout May 26th, 2024.
Under certain conditions – extensions for the validity of these certificates can be granted:

• For class III custom-made implantable devices – May 26th, 2026.
• For other class III devices and for class IIb implantable devices – December 31st, 2027.
• For medium and lower risk devices (other class IIb devices, and class IIa ls, lm, lr, I) – December 31st, 2028.

The extension will only be granted for products whose MDR transition had started and had their application submitted before the original deadline of May 26th, 2024.
At that point, the application must already have some basic established ground. The regulation defines exactly what provisions must be met by that time.