EU Guideline Tackles IVD Borderline, Classification Issues

The European Commission has published a final guideline aimed at clarifying borderline and classification issues related to in vitro diagnostic (IVD) devices. Products for general laboratory use are not IVDs, and not regulated under the IVD directive (IVDD), unless they are specifically intended by the manufacturer to be used for in vitro examination, the guideline states. Products not suitable for IVD testing cannot bear the CE mark.
International Medical Device Regulatory Monitor