Formal proposal to delay IVDR
Updated: Nov 4, 2021
The proposal does not change any requirements of the Regulation but only changes the transitional provisions to allow the Regulation's progressive rollout. The length of the proposed transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.
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