SRN / Actor Registration in EUDAMED
Get the actor side right first: SRN is the gateway for Manufacturer / AR / Importer roles and unlocks module access.
Practical checklist + clean handover outputs. No fluff.
Who needs SRN?
If you act in the supply chain, you likely need Actor Registration.
- Manufacturer
- Authorised Representative (AR)
- Importer
- System / Procedure Pack producer
What to prepare
A clean dataset prevents back-and-forth and delays.
- Legal entity + addresses (incl. VAT / registration where applicable)
- Role(s) in EUDAMED (Manufacturer / AR / Importer)
- Contact persons (regulatory / technical / vigilance)
- PRRC details (where required)
- Information security basics for account access
What you get
Outputs you can hand over to partners, AR, and internal QA.
- Submission-ready Actor Registration checklist
- Structured data sheet + evidence pointers
- Handover pack (who/what/where) + change log
- Optional: next-step map to Device / UDI datasets
Common failure modes (and how we avoid them)
- Role mismatch (Manufacturer vs AR vs Importer) → explicit role mapping and review
- Inconsistent legal entity naming across documents → one canonical master record
- Missing PRRC details → requirement check per role and regulation context
- Handovers with no traceability → evidence pack + versioned change log
Next steps
After SRN
Device / UDI datasets are where most teams lose weeks. We make them submission-ready with validation.
See UDI OpsNeed the big picture?
Modules, mandatory dates, and preparation patterns — source-linked.
Open EUDAMED primer