On December 20, 2021, the European Commission issued a Press release on the positive adoption by the European Parliament and the Council of the proposal of October 2021, for a progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation of 2017.
The amending Regulation does not change any requirements of the original IVDR. It only changes the dates of application of some of these requirements for certain medical devices.
For higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply as from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of application is extended until May 2026, whilst for lower risk class devices (class B and A sterile), the application starts in May 2027.
Moreover, 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 prove the unavailability of an equivalent device on the market, the transitional periods will end in May 2028.
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Source: European Commission