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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