EU + Switzerland registration: EUDAMED and swissdamed, aligned delivery
One operational view across EUDAMED and swissdamed: what aligns, what differs, key dates, 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).
EUDAMED (EU)
EUDAMED is the European Database on Medical Devices under MDR/IVDR, built as connected modules across the lifecycle (actors, UDI/devices, certificates, surveillance).
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.
swissdamed (Switzerland)
swissdamed is Swissmedic’s database for economic operators and devices on the Swiss market, aligned in structure to EUDAMED to reduce effort—without direct system-to-system sync.
Where they align
- Two-step logic: register the actor first, then register devices/UDIs.
- Dataset discipline matters: identifiers, ownership, grouping, and change history.
- Swissmedic accepts device data uploads in the EUDAMED DEVICE XML format for MDR/IVDR devices and procedure packs.
Where they differ
- Separate obligations and portals: no automatic transfer between EU and Swiss systems.
- Different “must-do” dates and transition rules; always validate per product situation.
- Operational reality: the same portfolio often needs two submission runs and two evidence trails.
Timeline snapshot
Treat this as orientation. Applicability depends on device status and reporting obligations.
Reality check (integration)
Data pipeline view (what your IT team cares about)
1) Data ingestion
Gather actor + UDI/device data from ERP/PLM/labeling, then normalize identifiers and ownership across EU + CH.
2) Validation
Validate once against strict rules, then apply system-specific checks (module scope, mandatory fields, value sets).
3) Packaging
Produce EUDAMED-ready exports and swissdamed XML from the same master dataset with versioning + audit trail.
4) Submission ops
Operate updates like releases: change control, approvals, submissions, verification, and evidence retention.
Always verify official guidance for your specific device and reporting situation.
What we deliver
- Portfolio triage: what’s in scope, who must register, and which dataset owners are needed.
- Data mapping and validation gates (fail-closed): completeness, consistency, and version checks.
- XML packaging for submission (EUDAMED / swissdamed device formats where applicable).
- Audit trail outputs: evidence of inputs, transforms, checks, and change history.
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.
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.
- 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.
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