FAQEU

EU MDR FAQ EUDAMED Modules

EUDAMED is the MDR database for medical-device lifecycle information across economic operators, device identifiers, certificates, clinical investigations, vigilance and PMS, and market surveillance.

Use this FAQ to separate the EUDAMED module that owns each record and to avoid treating one registration entry as proof that every MDR duty is complete.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
3

Structured answer sets in this page tree.

Primary sources
5

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

The EUDAMED modules that matter under the EU MDR are actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. The practical control is to keep each submission record with the module, actor, device identifier, certificate or event, source URL, owner, and follow-up trigger it belongs to.

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3 of 3 questions
Question 1

Which EUDAMED modules matter under the EU MDR?

EUDAMED is not one generic evidence bucket. The Commission describes six modules: actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.

For MDR work, map the record to the module that creates or receives it. Actor registration identifies the economic operator and SRN. UDI/device registration identifies the device, Basic UDI-DI, UDI-DI, EMDN data, market status, and legacy-device links where relevant. The notified bodies and certificates module holds certificate and notified-body information. Clinical investigations, vigilance/PMS, and market surveillance each have their own electronic-system purpose under the MDR.

  • Actor registration: manufacturer, authorised representative, importer, or system/procedure pack producer registration, SRN, registration request, supporting documents, and user access roles.
  • UDI/device registration: Basic UDI-DI, UDI-DI, device data, EMDN code, legacy-device data where applicable, and updates to device records.
  • Notified bodies and certificates: notified-body designation context, certificate information, certificate status changes, restrictions, refusals, suspensions, withdrawals, or reinstatements.
  • Clinical investigations: applications, single identification numbers, substantial modifications, reports, summaries, and adverse-event reporting that the MDR routes through the clinical-investigation electronic system.
  • Vigilance/PMS: serious incident reports, field safety corrective actions, field safety notices, PSURs for relevant devices, trend reports, and competent-authority coordination records.
  • Market surveillance: authority inspection reports, surveillance summaries, non-compliance measures, risk evaluations, and communications between competent authorities, the Commission, and notified bodies where the MDR requires them.
Citations
Regulation (EU) 2017/745 on medical devices

Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.

Question 2

What practical records should teams keep for EUDAMED module work?

Keep a module-level record that explains what was submitted or reviewed, why it belongs in that module, who owns the EUDAMED account action, and what must be updated when the device, certificate, incident, investigation, or authority status changes.

For actor work, retain the actor registration request, SRN, competent-authority approval trail, information-security declaration, authorised-representative mandate summary for non-EU manufacturers where applicable, and the active Local Actor Administrator coverage needed to preserve access. For UDI/device work, retain the Basic UDI-DI, UDI-DI, EMDN code, market status, certificate references where required, legacy-device link logic, version history, and update rationale.

  • Link each EUDAMED record to the legal manufacturer, authorised representative, importer, or system/procedure pack producer that owns it.
  • Keep UDI/device registration data aligned with the technical documentation, labels, certificates, SSCP where relevant, and change-control record.
  • For certificates, keep the notified body, certificate number, certificate type, scope, status, restrictions, and any related suspension, withdrawal, reinstatement, refusal, or amendment record.
  • For clinical investigations, keep the EUDAMED identifier, application dossier, substantial modifications, adverse-event reports, final report, and public summary status.
  • For vigilance/PMS, keep the report type, device identifier, incident or trend facts, FSCA/FSN record, PSUR where relevant, competent-authority correspondence, and closure rationale.
  • For market surveillance, keep inspection reports, non-compliance findings, measures required of economic operators, notified-body notifications, and authority communications.
Citations
Regulation (EU) 2017/745 on medical devices

Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.

Question 3

What should not be inferred from an EUDAMED entry?

A EUDAMED entry is not the same thing as a full MDR compliance conclusion. MDR Annex VI states that presence of a device UDI-DI in the UDI database must not be assumed to mean that the device conforms with the Regulation.

Treat EUDAMED as a structured registration and reporting system. The underlying MDR evidence still sits in the QMS, technical documentation, clinical evaluation, PMS/PMCF records, vigilance files, certificate files, labels, and change-control records.

  • Do not treat actor registration or an SRN as proof that device technical documentation, conformity assessment, or PMS duties are complete.
  • Do not treat UDI/device registration as proof of conformity; keep the conformity evidence and device-registration record cross-referenced but separate.
  • Do not mix clinical-investigation records with post-market vigilance reports unless the MDR route for the event actually requires that linkage.
  • Do not cite national enforcement details, guessed module go-live dates, or future EUDAMED releases unless the source folder contains current grounded support.
Citations
Regulation (EU) 2017/745 on medical devices

Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.

Recommended next step

Map EUDAMED records to the right MDR module

Use this EU MDR FAQ to separate actor, UDI/device, certificate, clinical investigation, vigilance/PMS, and market-surveillance records before building evidence workflows.

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Primary sources

References and citations

European Commission - Actor registration module
health.ec.europa.eu
Referenced sections
  • Commission module page for actor registration, Single Registration Number, actor request process, required documents, and access roles.
"Actor registration is the first of the six EUDAMED modules"
European Commission - UDI/Device registration
health.ec.europa.eu
Referenced sections
  • Commission module page for UDI/device registration, manufacturer device submissions, EMDN use, legacy-device registration, and the UDI helpdesk.
"manufacturers submit in EUDAMED the UDI/Device information"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.
"different electronic systems to collate and process information"
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