In brief
Since 28 May 2026, four EUDAMED modules are mandatory (Commission Decision (EU) 2025/2371). The obligation is clear; navigation is not: fragmented information, a demanding interface, and filings that often trigger at least one round-trip. That is not inevitable: you can prepare the file before opening the portal, and know where else to look.
For a medical device, the issue is not only “filling a form”: a stable product identity (UDI / Basic UDI-DI), registered economic operators, and data aligned with the technical file and CE certificate. This guide covers what to prepare, useful deadlines, and friendlier search tools (BEUDAMED, DM Atlas). This is not legal advice; always verify official status with the Commission and EUDAMED.
What has been mandatory since May 2026
Commission Decision (EU) 2025/2371, published on 27 November 2025, triggered a six-month countdown. As of 28 May 2026, four EUDAMED modules became mandatory:
- Actor Registration (economic operator registration, SRN)
- UDI/Device (device identification and registration)
- Notified Bodies & Certificates
- Market Surveillance
The Vigilance and Clinical investigation / performance study modules are not part of this first mandatory wave. Track official status module by module: the calendar moves through Commission decisions, not rumours.
Useful follow-up date: the MDR legacy device registration transition targets around 28 November 2026. IVDR legacy timelines can differ: always check official sources for your regime (MDR or IVDR) and product status.
What EUDAMED is for, for a medical device
EUDAMED supports transparency and traceability on the EU market: who places what, under which UDI identity, with which certificates, and with which operators. It is not a substitute for CE marking or the technical file. You do not “validate” a medical device by registering it: you make visible data that must match your regulatory evidence.
The software-specific difficulty: translating versions, distribution channels, cloud updates and possible variants (native app, web, API) into coherent device data. Marketing talks about “v3.2”; EUDAMED and the technical file need a stable regulatory identity (Basic UDI-DI, UDI-DI, versioning policy). Without that translation, registration becomes a source of audit inconsistencies.
Who does what
Three roles come up often:
- Manufacturer: owns product identity, device data, and consistency with the technical file and certificate.
- Authorised representative: required if the manufacturer is outside the EU; must be registered as an actor.
- Importer: registered when placing the device on the EU market from a third country.
Do not start device registration before actors are ready (SRNs obtained, roles clarified). A UDI/Device file blocked because an actor is missing wastes time when deadlines tighten.
What a medical device must prepare
Before entering anything in EUDAMED, gather the following. This is product / RA / quality team work, not an isolated “end task”.
Step 1 · Product and class
Frozen intended purpose and documented MDR (or IVDR) classification. Without that, EUDAMED fields and the certificate will not align.
Step 2 · UDI identity
Basic UDI-DI and UDI-DI versioning policy (when a release creates a new UDI, when it stays under the same one). Critical for cloud or multi-channel medical device.
Step 3 · Names and descriptions
Trade name, description, and wording aligned with intended purpose, IFU and labelling. Avoid marketing jargon that contradicts the file.
Step 4 · Certificates and actors
Certificates / notified body, manufacturer / authorised representative / importer details, evidence that EUDAMED data do not contradict IFU, labelling and the technical file.
Sequencing with CE marking
Treat EUDAMED as a workstream parallel to CE marking, not a box to tick on the last day. Recommended order:
- Qualify and classify the software (MDR / IVDR, medical device vs non-device).
- Build the technical file and QMS (including software lifecycle; see IEC 62304).
- Define the UDI strategy (Basic UDI-DI, version rules).
- Obtain conformity evidence and the CE certificate where applicable.
- Register actors, then devices in EUDAMED.
- Maintain data after each regulatorily significant release.
A medical device that iterates continuously cannot treat EUDAMED as a one-shot task. Plan who updates what after a release, and with which trigger (UDI change, new certificate, new operator).
Where to search more easily: EUDAMED, BEUDAMED and DM Atlas
The official EUDAMED portal remains the source of truth for obligations and filings. The tools below help you consult and explore public data; they do not replace registration or legal obligations.
BEUDAMED
BEUDAMED (beudamed.com), from OpenRegulatory (“Better EUDAMED”), offers unified search and a faster UX over public EUDAMED (and FDA) data. Useful for exploring actors and devices without fighting the official interface.
DM Atlas
DM Atlas (dm-atlas.fr) offers a French-friendly interface over public EUDAMED registry data (companies, devices, etc.). An EN-oriented entry point is also available at md-atlas.com.
Important clarification: consultation ≠ filing. Registration and legal obligations stay on official EUDAMED and with competent authorities. Use BEUDAMED / DM Atlas to orient yourself, check what is already public, or prepare your file; not to “replace” the regulatory portal.
Common pitfalls
- Marketing version vs regulatory identity: product “v4” does not automatically equal a new UDI-DI. Document the rule.
- Cloud update governance: without a clear rule (when to update EUDAMED), data drifts after every deploy.
- Incomplete actors: starting UDI/Device before manufacturer / authorised representative / importer SRNs.
- Misaligned descriptions: EUDAMED text that does not match the intended purpose in the technical file.
- One-shot mindset: register once, then ignore subsequent releases.
- Planning on rumours: inventing a module calendar from social media instead of official Commission / EUDAMED status.
Action checklist
- Confirm the official status of the four mandatory modules (since 28 May 2026) for your case.
- Map manufacturer, authorised representative and importer; obtain SRNs before the device.
- Freeze intended purpose and MDR/IVDR class in line with the technical file.
- Define Basic UDI-DI and the UDI versioning policy for the medical device (including cloud).
- Align trade name, EUDAMED description, IFU and labelling.
- Prepare certificate / notified body data before entry.
- Check that no EUDAMED field contradicts the technical file.
- Plan post-release maintenance (who updates, which trigger).
- Use BEUDAMED or DM Atlas to explore, not to replace official filing.
- Track the legacy deadline (~28 Nov 2026 MDR) and verify IVDR timelines if applicable.
Conclusion
EUDAMED since 2026, for a medical device, is first a maze you navigate better when prepared: product identity, operators, CE-file consistency, then data entry. Anticipate round-trips by aligning data before you open the portal, maintain after each significant release, and keep the official portal as the reference for obligations. Search tools (BEUDAMED, DM Atlas) help you find the info; they do not carry regulatory responsibility for you.
Going further
If you are structuring a medical device (qualification, UDI, dossier, registration) and want to clarify the sequence with your product / RA team, the QARA PULSE team can discuss a concrete case. Qapsule also helps keep traceability and evidence plugged into your tools. Contact QARA PULSE to start.
FAQ
Does EUDAMED replace the technical file?
No. EUDAMED is an EU database for registration and transparency. The technical file, QMS and CE marking remain separate obligations. Data entered must be consistent with those evidence packs, without replacing them.
Do you need a UDI for a cloud medical device?
Yes. A medical device placed on the EU market needs a UDI strategy (Basic UDI-DI and UDI-DI) suited to your versioning and deployment model. Cloud delivery does not remove the need for a stable, traceable device identity.
When should you start preparing EUDAMED registration?
As soon as qualification, classification and the UDI strategy are stable, ideally in parallel with the technical file, not after placing on the market. Economic operators (manufacturer, authorised representative, importer) must be ready before device registration.
What if the manufacturer is outside the EU?
A non-EU manufacturer needs an authorised representative in the Union. Manufacturer and authorised representative must be registered as actors (SRN) before pushing device data. Also anticipate the importer role where relevant.
How do you track module-by-module obligations?
Rely on official European Commission decisions and communications and the EUDAMED portal. Commission Decision (EU) 2025/2371 triggered the obligation for the first four modules. Do not plan on LinkedIn rumours: verify each module’s official status.
QARA PULSE guide on EUDAMED registration for a medical device. This is not a certification, nor personalized legal advice. Always check official Commission / EUDAMED texts and status, and adapt practices to your product, QMS and notified body expectations.