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Getting up to speed with the coming EU clinical evidence requirements for IVDs

This article was originally published in SRA

Executive Summary

Clinical evidence requirements are among the new rules that are going to have the biggest impact on the IVD industry once the forthcoming EU IVD Regulation eventually takes effect. IVD manufacturers would do well to make use of the transition period before the new regulation takes full effect – this is likely to happen around the end of this decade – and start gathering and documenting their evidence now.

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