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

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.

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.

CTSs, which are intended to ensure a common approach for pre-market assessment for high-risk diagnostics and thereby ensure consistency of...

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