European Commission proposes IVDR transition timescale amendment

The EU Commission has proposed an amendment to the transition of the In Vitro Diagnostic Regulation (IVDR, 2017/746) according to a press release and an accompanying Q&A webpage.

In summary, the Commission has proposed that 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. There is no change proposed for class A (non-sterile) or for new devices that will not have a declaration of conformity before May 2022.

This is not confirmed as yet, and is merely the first step of the legislative process which will require agreement from all EU institutions. If ratified, it will then become legally-binding and published in the EU Official Journal.

This is a very welcome step for industry, given the current 26 May 2022 timeline for IVDR implementation, and the significant capacity issues the system is facing. With only six notified bodies designated so far under the Regulation, the ‘cliff edge’ for many IVD manufacturers was approaching rapidly.