Module 16 2024

17/10/2024

EUDAMED & Databases

• Regulators such as the FDAs GUDID and the EU Commissions EUDAMED which are more focussed on the Regulatory side of product information • Most Databases such as the US FDA 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

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EUDAMED

• Available Voluntarily Now 1. Actor Module – becomes Mandatory in January 2026 – Actor Registrations – Manufacturers, Authorised Representatives, Importers. SRN numbers issued when registered. 2. Device (UDI) Module – becomes Mandatory in January 2026 – Device Registrations – Devices registered under Basic UDIs and UDIs. 3. Certificate Module – becomes Mandatory in January 2026 – Certificate Registrations – Notified Bodies register Certificates and relevant statuses. • Still in Development 4. Post Market Surveillance Module – becomes Mandatory in January 2026 – Post Market surveillance Reporting. 5. Vigilance Module – becomes Mandatory in July 2026 – Vigilance Reporting. 6. Clinical Module – TBC (2027) – Clinical Investigations / Performance Studies – Manufacturers. 7. Public Module – data becomes available as and when modules go live. – Non-confidential data from all modules. – Data to be included in public module as and when modules go live. Voluntary modules being used are already visible.

The Organisation for Professionals in Regulatory Affairs

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