EUDAMED

EUDAMED is the European Database on Medical Devices, an information system supporting the EU medical device and in vitro diagnostic frameworks. It connects information about economic operators, devices, certificates and regulatory oversight. Public access and restricted regulatory functions coexist, so not all information is visible to everyone.

Key Takeaways

• EUDAMED has six interconnected modules, with different users, functions and implementation stages.
• Four modules became mandatory on 28 May 2026, including market surveillance for competent authorities and the Commission.
• Manufacturers should check device-specific transition rules rather than assuming every existing record had the same registration deadline.

Which EUDAMED Modules Are Operational?

The European Commission identifies actor registration, UDI/device registration, notified bodies and certificates, and market surveillance as the first mandatory modules. Its overview distinguishes these from clinical investigations/performance studies and vigilance/post-market surveillance. The system includes both public and restricted access. Always confirm the current module instructions and transitional provisions before preparing an upload; the start of mandatory module use is not the same as a single deadline for all historical devices.

Primary guidance: European Commission EUDAMED overview; FAMHP transition clarification.

Why It Matters for Data Protection

For a hypothetical diagnostic manufacturer, we recommend separating the regulatory registration owner from the person approving personal information for disclosure. Review contact details, certificates and attached documents before upload, particularly where a document prepared for a restricted audience may enter a public workflow. Maintain an internal record of the submitted version and correction process. A useful control is a two-person check of the destination, module and visibility level, rather than assuming that an authenticated portal guarantees confidentiality.

Frequently Asked Questions

Is all EUDAMED information public?

No. The system has public and restricted functions.

Is EUDAMED itself a device approval?

No. Database registration is distinct from conformity assessment and other regulatory obligations.

Are all six modules mandatory now?

No. Check the Commission’s current module status and applicable transitional rules.

Related reading: medical device regulation mdr; in vitro diagnostic regulation ivdr.

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Updated: 27 October 2026