Medical Innovation Exchange

EU IVDR

European Commission Proposes Extension for EU IVDR Compliance

European Commission Proposes Extension for EU IVDR Compliance     On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The Comission noted that its goal in revising the deadline is to ensure patient care by improving …

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Ask the Expert: The Impact of IVD Regulations on Manufacturing

Ask the Expert: The Impact of IVD Regulations on Manufacturing     In vitro diagnostic (IVD) devices are medical devices used to perform tests on human specimens such as urine, blood, or tissue, to help diagnose diseases or monitor health conditions. IVD devices play a crucial role in healthcare, as they enhance accurate diagnoses and treatment …

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