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Medical Device Europe Regulation

EU IVD Regulation: A New Scrutiny System For Diagnostics

This article was originally published in The Gray Sheet

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Executive Summary

A European Union-centralized scrutiny system will be put into place for high-risk products under a new EU regulation for in vitro diagnostics that is heading toward adoption in the coming months.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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