Commission document clarifies IVD (in vitro diagnostic) borderline issues
This article was originally published in Clinica
The European Commission has published guidance for manufacturers, in the form of a so-called meddev document, on borderline issues for in vitro diagnostics and devices. This is the first such document, which provides guidance in particular on how to distinguish whether a product is a medical device or a diagnostic, since different regulatory regimes apply to each of these product sectors.
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