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.
Read the Commission’s Regulation amending the transition dates for compliance with the EU’s MDR.
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