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EU Commission Proposal to delay the transitional deadlines for medical devices

09 December 2022 : Proposal to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR) by the European Commission and supported by European Council members:

-  Higher risk class III and class IIb devices to 2027 instead of May 2024 at the latest.
-  Class 1 devices (which need a NB certificate under MDR) to 2028 instead of 2025
-  Class IIa devices to 2028 instead of May 2024 at the latest.

-  Removal of the “sell off” date of May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR).

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