Module 19 2021

01/06/2021

Traceability and eudamed

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 EUDAMED will be partially visible to public

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Eudamed under the IVD regulation

• Future intended use is extended • Relevant to all stakeholders • Will be the gateway to traceability • Partial accessibility by public • UDI data for products uploaded by manufacturers forms basis

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