Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

IVDR built to ensure transparency and traceability to improve health and safety Not sole responsibility of Manufacturer, all economic operators have responsibility EU commission will expand the EUDAMED data base to facilitate process

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EUDAMED will be partially visible to public

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Future intended use is extended

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Relevant to all stakeholders

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Will be the gateway to traceability

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Partial accessibility by public

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• UDI data for products uploaded by manufacturers forms basis

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