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European IVD Directive draft includes "common technical specifications" for highest-risk tests.

This article was originally published in The Gray Sheet

Executive Summary

IVD "COMMON TECHNICAL SPECIFICATIONS" ADDED TO EUROPEAN DIRECTIVE for blood grouping and retroviral tests. Under the latest draft of the European Union directive for in vitro diagnostics, manufacturers of designated high-risk tests could no longer bring the products to market simply by meeting quality systems requirements; they would also have to submit a design dossier for review by a notified body showing compliance with the common technical specifications.
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