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EU council on track with medtech reforms, new way forward proposed for reprocessing

This article was originally published in SRA

Executive Summary

The Latvian Presidency of the Council of the European Union is well on track to agreeing a set of amendments to the European Commission's proposed Medical Device Regulation and proposed IVD Regulation1,2. In addition, the proposed amendments suggest solutions to some issues that have been difficult to resolve, in particular the regulation of reprocessing of single-use devices and the regulation of high-risk devices.

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