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GUIDELINES ON MEDICAL DEVICES IVD Medical Device …

    https://www.medical-device-regulation.eu/wp-content/uploads/2019/05/2_14_1_rev2_ol_en.pdf
    IN VITRO DIAGNOSTIC MEDICAL DEVICES: BORDERLINE ISSUES CONTENT Introduction Part A – Qualification 1. General principles of qualification 1.1. Definition …

Overview of IVD Regulation | FDA

    https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
    How are IVDs classified? The FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary …



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