swissdamed: Swiss medical devices database in plain language
What swissdamed is, who must register, how it aligns with EUDAMED, and what to prepare.
We support swissdamed/UDI data work and submission readiness. We are not a CH-REP. If a CH-REP is required, we coordinate with your appointed representative.
- Source-linked guidance (official first).
- private detail sharing: minimum necessary artifacts, with selective sharing when needed.
- Traceable outputs: mapping + validation notes + versioned packages.
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 it is
swissdamed is Swissmedic’s database for registering economic operators and medical devices placed on the Swiss market, with a public search portal to increase transparency.
Who is affected
Swiss manufacturers, authorised representatives (for mandated devices), persons assembling systems/procedure packs, importers and other economic operators as applicable under Swiss ordinances.
Modules at a glance
swissdamed consists of two modules aligned to corresponding EUDAMED modules:
- Actors module (economic operators / identifiers)
- UDI Devices module (device and UDI datasets)
State of play and key dates
Swissmedic reports the Actors module has been available since August 2024 and modules are rolled out gradually; device registration guidance links EU milestone dates and Swiss obligations.
What to prepare
Ensure your actor registration/identifier data is complete, your device datasets are coherent, and responsibilities for submissions and updates are defined. Treat data quality and traceability as first-class work, not paperwork.
How it relates to EUDAMED
Swissmedic aligns swissdamed design to EUDAMED to reduce effort. There is no interface between the systems; operators upload device data to swissdamed in the required structured format (scope‑dependent; validate against official guidance).
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.