Swissdamed device registration in Switzerland
A high-level update to help you assess impact, timing, and preparation steps. This page avoids operational implementation details and links only to official sources.
TL;DR
- Mandatory device registration starts 1 July 2026; transition until 31 Dec 2026.
- No transition for vigilance cases (serious incidents / FSCA / trends): register from day one.
- Best prep: clean UDI datasets, align actor data (CHRN), and validate against Swissmedic guidance.
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.
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.
Which one are you?
Pick the track that matches your situation; the obligations and the fastest next step differ.
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.
Always verify applicability (e.g., “old devices”, vigilance scope) against Swissmedic guidance.
Registration workflow (overview)
Swissdamed work typically falls into three linked tracks.
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11) Actor registration (CHRN / roles)Define roles, mandates, and organization data. Ensure at least two admins.
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22) Device/UDI datasetsClean UDI-DI/UDI-PI, packaging levels, and attributes; validate before upload.
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33) Maintain & evidenceKeep registrations current and store decision records and submission evidence.
Reality check (IT)
Data pipeline view (what your IT team cares about)
1) Data ingestion
Collect master data from Excel/CSV, PLM/ERP (e.g., SAP), labeling systems, and certificate records—then normalize identifiers and ownership.
2) Validation
Run schema + business-rule checks (mandatory fields, formats, uniqueness, packaging levels). Fail fast before any upload.
3) Packaging
Generate portal‑aligned structured submissions with versioning, change logs, and an audit trail.
4) Submission ops
Define cadence, roles, and evidence storage. Treat updates like releases: review → submit → verify → archive.
Do-now checklist
- Confirm actor roles (who submits) and ensure at least two portal admins.
- Prioritize your portfolio (what must be registered first) and map ownership for each device/UDI.
- Clean and standardize identifiers (UDI-DI, Basic UDI-DI where applicable, GTIN, model/version).
- Decide your pipeline: manual XML now, automation later—start with repeatable validation.
- Set a maintenance routine (change control + evidence): updates aren’t optional.
How we help
Deterministic checks, clean data contracts, and audit-grade outputs — without exposing your private product details publicly.
- Portfolio triage: obligations, roles, and deadline mapping.
- Data hygiene & validation: UDI completeness, packaging logic, consistency across PLM/ERP/labeling.
- Submission packaging: repeatable exports, manifests, and change records.
- Operational model: ownership, two-admin resilience, and maintenance cadence.
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.
Regulatory updates
Get a compact email when Swissdamed/UDI timelines or guidance changes. No tracking.