What it is and what changed in 2026
EUDAMED is the European database on medical devices set up under the MDR and IVDR. Regulation (EU) 2024/1860 allowed it to go live module by module instead of waiting for the whole system.
Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, declared the first four modules functional. That started a six-month transition, and since 28 May 2026 these modules are mandatory:
- Actor registration
- UDI and device registration
- Notified bodies and certificates
- Market surveillance (for competent authorities and the Commission)
Still to come: clinical investigations and performance studies (under analysis) and vigilance and post-market surveillance (in development). The Commission says there will be no voluntary period before those become mandatory, so companies should prepare in advance.
The MDCG has issued related guidance, including MDCG 2026-4 on summaries of safety and (clinical) performance in EUDAMED after mandatory use.
Where to find it
- Public EUDAMED site at ec.europa.eu/tools/eudamed, with search for actors, devices, certificates, and notified bodies.
- Restricted site for registered economic operators and authorities.
- Commission EUDAMED overview page for module status, news, and links to the legal notice and privacy policy.
Reuse terms: why “check required”
The Commission’s general legal notice applies CC BY 4.0 to Commission-owned content unless otherwise indicated. EUDAMED is different from a guidance page in ways that justify our caution:
- Data comes from economic operators, not only the Commission, so third-party rights may apply.
- Personal data appears in actor records (contact persons, PRRC details).
- Site-specific terms and the privacy policy should be read before any automated retrieval or bulk use. We could not confirm data-specific reuse terms on the public pages we opened.
- Accuracy depends on what operators registered, and records change.
Using EUDAMED data in AI and RAG
- Read the EUDAMED legal notice and privacy policy and record the version you relied on.
- Avoid scraping the public site. Use official downloads or interfaces if offered, and respect rate limits.
- Strip personal data before indexing actor records.
- Record the retrieval date on every record; registrations and certificates change.
- Keep your own restricted-site data in a private workspace, never mixed with public data.
- Use EUDAMED to verify, not to define, requirements. Cite the MDR or IVDR for obligations.
Common mistakes
- Assuming CC BY covers operator-supplied data and personal details.
- Indexing a snapshot and never refreshing it.
- Waiting for a voluntary period for the vigilance module, which the Commission says will not exist.
- Using EUDAMED certificate data in supplier assessments without checking the date.
Checklist
- EUDAMED legal notice and privacy policy reviewed
- No scraping; official access routes only
- Personal data removed
- Retrieval date on every record
- Restricted data kept private
- Requirements cited from MDR or IVDR
How AskDona helps
AskDona can compare your internal device master data and certificate lists with the EUDAMED records you supply, and show each mismatch with its source and retrieval date. Your regulatory team keeps control of what data is used.
Run a sample EUDAMED data consistency check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “check required” rating comes from our source list and is a first-pass judgment, not a legal opinion. Review EUDAMED’s own terms before any automated use.
FAQ
Which EUDAMED modules are mandatory? Since 28 May 2026: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.
When will vigilance become mandatory? No date yet; the module is in development, and the Commission says there will be no voluntary period.
Can I scrape EUDAMED for an AI tool? We advise against it. Check the site’s terms and privacy policy, and use official access routes.
Is EUDAMED data CC BY 4.0? Not safely assumed. Data comes from operators and includes personal data, so check before reuse.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| European Commission: EUDAMED overview | Mandatory modules from 28 May 2026, Decision 2025/2371, modules still to come |
| Regulation (EU) 2024/1860 on EUR-Lex | Gradual roll-out of EUDAMED |
| European Commission: MDCG guidance | MDCG 2026-4 on SS(C)P in EUDAMED |
| European Commission legal notice | General CC BY 4.0 policy and exclusions |