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Consensus Builds For EU Reg Reforms As The Full Details Emerge

This article was originally published in The Gray Sheet

Executive Summary

The proposed texts for European-wide medical device and IVD regulations have won the support of the EU Commission and key Council and Parliament Committees, and, for the first time, have been posted for public review. Here is a first look at what awaits device companies with regards to EU scrutiny of high-risk devices and what negotiators settled on for oversight of single-use device reprocessing.

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