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The new transitional deadlines for medical devices

Tuesday 1 August 2023 , by (Rene Clement)

REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

New transitional deadlines for Medical Devices under the Medical Devices Regulation (MDR) :

  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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