EUDAMED Mandatory (2026)

EUDAMED is the central IT system the European Commission operates under MDR Article 33 and IVDR Article 30. It holds registrations and traceability data for every actor, device, certificate, investigation, vigilance event and market-surveillance action in scope of the MDR and IVDR. It replaces fragmented national databases with a single EU-level source of truth — visible to competent authorities, notified bodies, manufacturers, importers, distributors, authorised representatives, sponsors of clinical investigations and (in part) the public.

• Actor registration module — every economic operator (manufacturer, authorised representative, importer, system/procedure pack producer) gets a Single Registration Number (SRN).
• UDI / Device registration module — every device placed on the EU market gets a Basic UDI-DI and UDI-DI plus the data attributes in MDR Annex VI Part B.
• Notified Body and Certificates module — NBs publish issued, suspended, withdrawn and restored certificates.
• Clinical Investigations / Performance Studies module — sponsors register investigations, submit substantial-modification notifications and final reports.
• Vigilance and post-market surveillance module — serious incident and FSCA reporting; periodic safety update reports (PSUR).
• Market Surveillance module — competent authority actions, NCAR exchange.

Before 2024/1860, MDR/IVDR conditioned EUDAMED's mandatory use on a single 'go-live' of all modules together, triggered by a Commission notice. That all-or-nothing design kept slipping. 2024/1860 decoupled the modules: each module becomes mandatory six months after its full functionality is declared in the Official Journal, on a module-by-module basis.

• Actor, UDI/Device, NB & Certificates, and Vigilance modules — declared functional Q2 2026; mandatory ~Q4 2026.
• Clinical Investigations / Performance Studies module — functional declaration ~Q3 2026; mandatory ~Q1/Q2 2027.
• Market Surveillance module — functional declaration follows; mandatory six months later.
• Voluntary use of any already-deployed module remains available throughout — the legacy paper or national-database alternative is the parallel route until mandatory date.

For most manufacturers, UDI/Device is the operationally largest module. Every device requires a Basic UDI-DI (the model-level identifier) and one or more UDI-DIs (the production-variant identifiers). MDR Annex VI Part B specifies the data attributes — risk class, intended purpose, MDN/CND codes, single-use status, sterile status, latex content, MR safety, kit/system/procedure pack relationships, authorised representative link, certificate references, free-sale information and more — that must be populated and kept current.

Issuing entities accredited by the Commission (currently GS1, HIBCC, ICCBBA, IFA GmbH) assign the UDI-DI. The registration in EUDAMED is the manufacturer's responsibility and must precede or coincide with placing the device on the EU market. Changes to attributes require update within 30 days; the device may not be placed on the market until the update is reflected.

Once the Vigilance module is mandatory, serious incident reports (MIR), Field Safety Corrective Actions (FSCA), Field Safety Notices (FSN), trend reports and PSURs flow into EUDAMED and not into national parallel systems. Manufacturers must have the internal workflow — incident triage, MIR drafting, CA notification, FSCA decision, FSN distribution — wired to EUDAMED submission rather than to per-country forms. The reporting clocks (immediate for serious public-health threats; 10 days for death or serious deterioration; 15 days for other serious incidents) are unchanged.

EUDAMED has a public-facing layer and a restricted (authority/NB/manufacturer) layer. The public layer exposes device summary information, certificate status, summary of safety and clinical performance (SSCP for class III and implantable devices), FSN public summaries and aggregated registration data. Commercially sensitive data — internal incident details, full PSUR, full clinical evidence — remains restricted.

1. Confirm Actor registration (SRN) is in place and current — this has been mandatory since 2020 for many actors and is the foundation for every other module.
2. Catalogue every CE-marked device by Basic UDI-DI and UDI-DI, with the MDR Annex VI Part B attributes populated in a structured source of truth (PLM / RIM / QMS).
3. Map the gap between your current device registration data and the Annex VI Part B requirement; remediate before the mandatory date, not at it.
4. Wire vigilance reporting workflow to the EUDAMED MIR format. The Manufacturer Incident Report template is the unified format — convert internal forms to align.
5. Coordinate with your NB on certificate upload timing; certificates not in EUDAMED at the mandatory date are not a defence against market enforcement.
6. If you run clinical investigations or performance studies, plan for the CI/PS module mandatory date six months after the others — sponsor obligations are the most operationally novel.