2021-10

On October 14, 2021, the European Commission published a press release with a proposal for a progressive roll-out of the new IVDR.

The proposal does not change any requirements of the In Vitro Diagnostic (IVD) Regulation in substance 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.

The proposal and the press release can be downloaded in our library

Source: European Commission