Swissdamed actor module and CHRN: high-level preparation
A concise overview of prerequisites and data readiness steps before device registration. Links are placeholders pending official source confirmation.
TL;DR
- The Actors module is live; economic operator registration is handled via swissdamed (CHRN workflows).
- Access typically follows two tracks: register as an actor (request CHRN) or get onboarded by an existing actor admin.
- Best prep: role mapping, mandate readiness, and consistent organization data across systems.
We support data readiness and submission operations. We are not a CH‑REP. If a CH‑REP is required, we coordinate with your appointed representative.
- No statutory-role claims (CH‑REP/QMS certificates) unless explicitly stated.
- private detail sharing: minimum necessary, with an auditable handover trail.
- Deliverables are traceable: inputs → checks → outputs.
Role clarity: CH‑REP vs operational support
We do not act as a Swiss Authorized Representative (CH‑REP). We provide operational support for swissdamed/UDI and coordinate with your appointed CH‑REP/importer when required.
- No statutory-role claims (no CHRN/ISO statements) unless you provide them.
- We focus on data quality: inputs → validation → submission packages → change log.
- Handover is controlled and auditable (limited detail sharing).
What changed
Swissdamed introduces structured device registration and related obligations. The practical impact depends on your role and product portfolio.
Who is affected
Manufacturers, authorized representatives, and other actors may have obligations. If you operate outside Switzerland, local representation requirements can apply.
How do you get access?
Two legitimate paths exist; pick the one that matches your organization’s current state.
What happens next
Actor access is step 1. Device datasets and ongoing maintenance follow.
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11) Get CHRN / actor accessRoles, mandates, admins.
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22) Prepare device datasetsUDI completeness, packaging, validation.
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33) Maintain & evidenceKeep records current; store submission proofs.
Timeline and transitions
There can be transition periods, but some reporting obligations can be immediate in specific situations. Validate against the official guidance for your case.
What to prepare
Confirm actor data readiness, device dataset availability, and internal responsibility for submissions. Keep records consistent across systems.
Operational deliverables (what you actually get)
- A normalized dataset (owner + version) ready for submission.
- Validation report (schema + completeness + consistency checks).
- Upload‑ready structured submission packages aligned to portal expectations, plus a change log.
- A handover pack for your CH‑REP/importer when needed.
FAQ: CH‑REP coordination & swissdamed operations
Can you act as CH‑REP for Switzerland?
No. We do not provide statutory CH‑REP services. We support the operational side (data readiness, validation, packaging, submissions) and coordinate with your appointed CH‑REP when required.
Do I need a CH‑REP?
It depends on your role and location. We help you map roles and identify where CH‑REP involvement is required, then hand over clean, complete data.
What do you need from us to start?
- Device list / portfolio scope (SKUs, variants, intended markets)
- Identifiers (UDI‑DI / Basic UDI‑DI where applicable) and key attributes
- Actor details (legal name, addresses, roles) and current registrations if any
- Label/IFU PDFs for spot-checking consistency
How do you avoid sharing sensitive IP?
We use private detail sharing: only the minimum necessary fields for registration and submission, with optional selective sharing and an auditable handover trail.
What does “upload-ready” mean?
You receive a structured submission package plus verification artifacts (change log, integrity checks). Operator‑level templates, mappings, and portal‑specific steps are shared privately under a scoped agreement. Final acceptance still depends on the official portal validations.
Do you support both EUDAMED and swissdamed?
Yes. We align a single master dataset, then produce separate exports/packages for each system as required.
- Name + postal address must be shown where required (not PO box only).
- Keep it contactable and consistent across label/IFU and registrations.
- Use Swissmedic guidance as the source of truth.