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EU’s IVDR Clinical Evidence Comes Under The Microscope

Do you know what is required when it comes to providing clinical evidence for IVDs in the EU? Consultants at Maetrics explain how, given that the majority of  IVDs are about to find themselves in a higher risk class, there is a steep learning curve ahead. There will also be a scramble for the limited notified body resources available.

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It is paramount that IVD manufacturers who have not previously been required to collate clinical evidence start to plan their EU IVD Regulation adoption roadmap to ensure that their clinical evidence meets the new IVDR requirements. That will enable them to continue selling their products once the Regulation (2017/746) fully applies on 26 May 2022.

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