As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices on the European market.
Manufacturers of devices certified according to Medical Device Directive (MDD), also known as "legacy devices" according to MDR Article 120, can now benefit from longer periods for the transition of MDD certification to MDR.
Current adoption of timelines for transition to MDR leave numerous open questions und uncertainties. It is a quite common but incorrect interpretation that MDR transition is postponed to 2027 or 2028. Immediate action – before 2024-05-26 – is urgently necessary to maintain marketing authorisation for medical devices on the European market.
We have gathered the most important timelines in our news article on our website:
Timelines for Transition of Certification from MDD to MDR
If you are interested or have any questions about this procedure, please feel free to contact us. We are here to support and guide you through this transition.
We have also issued an urgent call for immediate action on our LinkedIn channel:
An urgent call for medical manufacturers
