Products for general laboratory use: What manufacturers and laboratories need to know to avoid problems and unnecessary expense

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One 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…

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Laboratory products for “Research Use Only” (RUO) – often a dangerous claim

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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…

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