Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…
DetailsOne assumption persists: Products for general laboratory use such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct? There is often a lack of clarity about Hence, there are uncertainties, in order not to make themselves liable to prosecution. This article provides clarity…
DetailsCompanion Diagnostics (also known as CDx) are used together with a medicinal product. Physicians use them, for example, to make sure that a particular medicinal product is actually suitable for a patient. This means that CDx play a particularly important role in personalized medicine. As the Companion Diagnostic and the medicinal product are inseparably linked,…
DetailsISO 13485 requires a medical device file for each medical device type or medical device family. Many manufacturers think that the medical device file is the same as the technical documentation required by the MDR or IVDR. But that isn’t entirely true. Does one of the three files required by the FDA (DMR, DHF, DHR) match the…
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