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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Sterilization of medical devices: A quick overview

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Because the quality of medical device sterilization is crucial to the safety of these medical devices, the selection and validation of the sterilization process are regularly subject to audits and inspections. This article provides a quick overview of the various sterilization processes and regulatory requirements for medical devices and offers best practices for successfully passing…

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MDR Classification Rule 11: The classification nightmare?

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The MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…

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Computerized Systems Validation CSV

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We frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements.

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