EUDAMED Registration: SRN, UDI, and the Phased Mandatory Deadlines Explained
Quick answer: EUDAMED is the EU's central medical device database, built as six modules: actor registration, UDI/device registration, notified bodies & certificates, clinical investigations, vigilance, and market surveillance. Regulation (EU) 2024/1860 decoupled the modules, making each mandatory on its own schedule once audited and declared functional — with mandatory use of the first modules phasing in from 2026. Every manufacturer, authorised representative, and importer needs a Single Registration Number (SRN); device registration requires UDI data prepared to the EUDAMED data dictionary. Because deadlines are set by Commission notices, verify the current timeline on the European Commission's EUDAMED page — and build your data now, not at the deadline.
The six modules and what lives in each
Actor registration. Manufacturers, ARs, importers, and system/procedure-pack producers register to obtain their SRN — the identity used across everything else, including notified body applications.
UDI/device registration. Basic UDI-DI and UDI-DI records for each device, with the associated data elements (risk class, nomenclature (EMDN), clinical size, sterility, etc.).
Notified bodies & certificates. Certificates issued, suspended, or withdrawn — populated primarily by notified bodies.
Clinical investigations and performance studies. Applications and notifications for investigational work.
Vigilance. Manufacturer incident reports, FSCAs, and periodic summary reports — replacing member-state-by-member-state filing once mandatory.
Market surveillance. Competent authority activities.
What manufacturers must actually do
Obtain your SRN via your competent authority's validation in the actor module. Non-EU manufacturers register through their authorised representative's member state. Expect verification steps — this is not instant.
Prepare UDI data. Assign Basic UDI-DIs (the design-level grouping) and UDI-DIs (per variant/packaging level) through an issuing entity (GS1, HIBCC, ICCBBA, IFA), then map your device data to the EUDAMED data dictionary. Data quality is the real project: nomenclature codes, certificate linkages, and legacy device handling generate most of the friction.
Register devices in the UDI/device module and keep records updated — changes to registered elements carry update obligations.
Prepare for vigilance-module go-live by aligning your vigilance procedure to electronic MIR submission.
The phased deadlines — how to read them
Regulation (EU) 2024/1860 amended the MDR/IVDR to allow module-by-module mandatory use: each module becomes obligatory six months after the Commission publishes a notice confirming the module is functional, following an independent audit. The first cluster (actor, UDI/device, notified bodies & certificates) entered mandatory use starting in 2026, with vigilance and remaining modules following. Practical consequence: your obligations arrive on the Commission's publication rhythm, not on a single memorable date — someone in your organisation (typically the PRRC or your external RA partner) must own tracking these notices.
Why registration is the easy part
Companies treat EUDAMED as a data-entry task and discover it is a data-governance task. The register must stay consistent with your technical documentation, certificates, labels, and declarations of conformity — permanently. A device description that differs between EUDAMED, the IFU, and the DoC is a finding waiting for an auditor. Build the maintenance workflow (who updates what, triggered by which change control) into the QMS at the same time you register.
Frequently asked questions
Is EUDAMED registration required for Class I devices? Yes — actor and device registration obligations apply to all classes once the modules are mandatory.
We already registered nationally. Does that still count? National registration requirements fall away as EUDAMED modules become mandatory; during transition, some member states maintain parallel requirements. Check both until the transition completes.
Who inside the company owns EUDAMED? Formally the manufacturer; operationally it needs a named owner with QMS-controlled update procedures. External RA/QA providers commonly run it — QLE Group operates EUDAMED registration and maintenance as part of its retainer infrastructure.
Where do I check the current mandatory dates? The European Commission's EUDAMED webpage publishes the module status and legal notices — treat it as the single source of truth.
About QLE Group
QLE Group handles EUDAMED actor and device registration, UDI data preparation, and ongoing register maintenance as part of its outsourced RA/QA infrastructure for MedTech companies, from Brussels. Delivered by Radoslav Milkov — qualified PRRC, ISO 13485 / 21 CFR 820 Lead Auditor, LL.M. in EU Law. Complexity-indexed pricing at qle.be.
EUDAMED deadline anxiety? Book a scoping call or email info@qle.be.
