EUDAMED: what it is, modules, and what becomes mandatory
Source-linked orientation for RA/QA teams: definition, scope, key dates, and preparation.
SRN is your actor-side entry point (Manufacturer / AR / Importer). Get this right before device / UDI datasets.
What it is
EUDAMED is the European Database on Medical Devices established under MDR/IVDR. It connects electronic systems across the device lifecycle to improve transparency and coordination.
Who is affected
Manufacturers, authorised representatives, importers, notified bodies, competent authorities, and—in some modules—sponsors of clinical investigations/performance studies.
Modules at a glance
Six interconnected modules plus a public portal.
- Actor registration
- UDI/Device registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
Actor registration (SRN) — process & responsibilities
SRN is issued by the competent authority. We prepare a submission‑ready actor dossier and guide the workflow (EU and non‑EU paths).
EU/EEA actor path
- Create EU Login / access prerequisites
- Submit Actor Registration request in EUDAMED
- Competent Authority assesses & validates
- SRN issued (keep evidence & keep details up to date)
Non‑EU manufacturer path
- Appoint an EU Authorised Representative (AR)
- AR verifies the registration request (pre‑check)
- Competent Authority assesses & validates
- SRN issued (keep mandate + evidence pack ready)
Checklist + gap report
We map required fields, owners, and evidence to avoid last‑minute surprises.
Submission‑ready dossier
Structured actor data + identifiers + attachments packaged for a clean handover.
Pre‑validation
Completeness & consistency checks to reduce rejects and rework.
Change log template
A simple audit trail so updates don’t become chaos.
Actor registration FAQ
What is an SRN and when do we need it?
How does the non‑EU workflow differ?
Who issues the SRN?
What do we need to prepare (minimum)?
Will actor data be public?
How do you reduce sensitive data exposure?
State of play and key dates
The European Commission describes a gradual roll-out. The first four modules are declared functional and become mandatory after the transition triggered by the 2025 Commission Decision and MDR/IVDR amendments.
What to prepare
Keep actor data, identifiers, device datasets (including Basic UDI-DI/UDI-DI concepts), certificates, and internal ownership aligned. Prepare to evidence data lineage and change history without last-minute rework.
EUDAMED package: Actor → Device/UDI → Upload/management
A bundled view of the work streams you need to run (and keep running).
1) Actor & SRN dossier
Submission‑ready actor data + attachments (EU and non‑EU paths) with a controlled handover.
2) Device & UDI dataset
Normalized identifiers (Basic UDI‑DI/UDI‑DI), ownership links, and scope decisions per module.
3) Upload & management
Validation gates (format + rule checks), versioned packages, and fast reject resolution.
4) Ongoing monitoring
Change control, evidence retention, and periodic re‑checks so updates don’t turn into chaos.
EUDAMED submission ops (data → validation → evidence)
A practical delivery model: align a master dataset once, export correctly, and keep an audit trail.
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11) Data intakeCollect actor + device identifiers and map your master dataset (Excel/CSV/ERP export) to EUDAMED fields.
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22) ValidationPerform pre‑submission validation checks (format + rule checks) before you upload. Operator‑level details are shared privately.
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33) PackagingGenerate upload-ready artifacts (XML/files) with versioning and a clear change log.
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44) Submission & monitoringSubmit, track responses, and resolve rejects fast (without random guesswork).
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55) Change managementKeep updates repeatable: who changed what, when, and why — and what was submitted.
- Missing/invalid identifiers (SRN, UDI-DI, certificates) or mismatched ownership links.
- XML looks “format‑ok” but fails on format checks / value constraints / cross‑field rules.
- Incomplete mandatory fields per module scope (wrong “who submits what”).
- No versioning: re-uploads overwrite context and create audit ambiguity.
- No evidence pack: you can’t explain what changed and why it’s compliant.
Two ways to run it
Quick start: manual / bulk
Best for early readiness: validate and package data, then upload in controlled batches with a change log.
Scale: M2M‑ready operations
Design the dataset + validation + audit trail so you can switch to machine‑to‑machine delivery when access is available.
Service levels
DIY (templates + checklists)
You execute. We provide structure‑only guidance: readiness checklist, mapping outline, and review gates (no operational templates publicly).
- Readiness checklist + gap list
- Structure‑only mapping outline (templates shared privately)
- Common reject reasons cheat‑sheet
Assisted submission
We prepare the packages and help you submit with confidence.
- Validation + packaging
- Upload-ready deliverables
- Reject resolution support
Managed ops
We run the workflow with you (clear roles), coordinate stakeholders, and keep the audit trail tight.
- Ongoing change management
- Evidence pack + change log
- Coordination with your AR/partners