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Industry still waiting for details of common technical specifications under IVD (in vitro diagnostic) Directive

This article was originally published in Clinica

Executive Summary

Industry in Europe is still none the wiser as to exactly which in vitro diagnostic (IVD) products perceived as having a high degree of potential risk will be subject to specific technical requirements or controls - the so-called common technical specifications (CTSs) - under the new IVD Directive when it takes effect next year. There has been progress on the matter, however.

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