The Commission of the European Union (EU) has modified the transitional provisions of its regulations under the EU’s Medical Device Regulation (2017/745, or MDR) and the In Vitro Diagnostic Regulation (2017/746, or IVDR) to reflect the current capacity constraints of currently designated notified bodies.
Regulation (EU) 2023/607 extends the validity date of certificates issued between May 25, 2017 and May 26, 2021 under the EU’s original directives on medical devices (90/385/EEC) and in vitro diagnostic medical devices (98/79/EC). For class III and certain class IIb devices, the new transition date by which a device manufacturer must demonstrate compliance with the MDR or IVDR is now December 31, 2027. The new transition date for all other class IIb devices and class IIa and class I devices is now December 31, 2028.
In addition, medical devices brought to market under the legacy directives during the original transition period based on a declaration of conformity but that now require notified body review under the MDR or IVDR may remain on the market until December 31, 2028.