Module 16 2022

05/09/2022

EUDAMED & Databases

• Regulators such as the FDAs GUDID and the EU Commissions EUDAMED which are more focussed on the Regulatory side of product information • The GUDID is a standalone UDI module storing the information listed in the previous slides against UDI-DI numbers. • EUDAMED is a much larger database with 7 different modules: • Actor Registrations / UDI (Product Registrations) / Certificates / Clinical / Vigilance / Market Surveillance / Public

The Organisation for Professionals in Regulatory Affairs

17

EUDAMED & Databases

The Organisation for Professionals in Regulatory Affairs

18

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