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EUROPE: The progressive roll-out of the EU Regulation 2017/746 (IVDR) has been published in the official EU journal

The Regulation (EU) 2022/112 has been published in the official European journal on January 28th, thus formalizing the progressive application of the Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices (IVDR). The proposal was launched in October 2021 and among the reasons of this roll-out, there was the need to avoid interruptions in the supply of IVDs essential for public health and the strong lack of designated Notified Bodies.

The regulation amendment adds some transitional provisions to the original regulation, as the date of application of the IVDR remains set at 26 May 2022. However, for devices that, in accordance with Directive 98/79/EC (IVDD), did not need certification but that will according to IVDR, the application date changes as below:

  • May 26, 2025 for class D IVDs
  • May 26, 2026 for class C IVDs
  • May 26, 2027 for class B IVDs
  • May 26, 2027 for sterile class A IVDs.

For devices certified according to IVDD, the put on the market deadline switches from May 26, 2024 to May 26, 2025.

On the other hand, no change is proposed for devices that do not require Notified Body involvement under the IVD Regulation, or for “new” devices, i.e. devices that have never been marketed pursuant to Dir. 98/79/EEC. For these types of devices, the IVDR will therefore apply from 26 May 2022 as provided.

Moreover, citing the Commission document in which the reasons for the progressive roll-out are defined, the application of certain requirements for devices manufactured and used in the same health institution (so-called ‘in-house devices‘) is delayed by two years until May 2024. If, however, the health institutions will prove the unavailability of an equivalent device on the market, the transitional periods will end in May 2028 (Art. 5, paragraph 5, letter d).

Written: Sofia Tabacco

Foto di: pixel2013 da Pixabay