IVD3: IVDR: Current state

IVD3

The first speaker was Olga Tkachenko from the European Commission and MDCG. She spoke about progress of the In Vitro Diagnostics Regulation (IVDR). Outlining the timeline, she reiterated the current transition calendar for IVDR and outlined the European Commission’s workstreams on IVDR and MDR transitions and its interactions with MDCG, EMA and competent authorities. Tkachenko then covered the MDCG’s focus on transition and availability of devices and discussed the points explained in MDCG-2022-14 position paper and the IVDR joint implementation plan, published in June, which is in the process of being updated.

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