December 2021: In Vitro Diagnostic Medical Devices Regulation Update

European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021:

The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage of essential medical devices and will come into force from May 26, 2022, as planned.

Keeping into consideration the high paucity of the notified bodies, it also notifies about the amendment to the IVD Regulation of 2017, that has changed the dates of application of some requirements for certain essential medical devices.

  • Higher risk devices (class D): New requirements will apply from May 2025
  • Lower risk devices (class C): The date of application is extended until May 2026
  • Lower risk class devices (class B and A sterile): Application starts in May 2027
  • In-house devices: Delayed by two years until May 2024

It also mentions that the transitional periods will come to an end in May 2028, if the unavailability of an equivalent device on the market is proved by the health institutions. However, no change is proposed for ‘new-devices’ or CE-marked devices that do not require notified body involvement, for these devices the IVD Regulation will apply from May 26, 2022.

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