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Tougher in vitro diagnostic (IVD) Directive safeguards finally win over the cautious French

This article was originally published in Clinica

Executive Summary

After years of debate, the French authorities now appear satisfied with new manufacturing controls which are to be introduced for high-risk products under the proposed In Vitro Diagnostics Directive. The controls, known as Common Technical Specifications (CTSs), respond to French demands for more stringent requirements for high-risk IVDs than were originally envisaged in the directive.

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