swissdamed
Product registration has been mandatory since 1 July 2026, with transition ending on 31 December 2026. Certain vigilance reports trigger immediate registration. The device case and economic operator role matter.
INSIGHTS
swissdamed: a guide to preparing your data
A practical checklist for Swiss manufacturers and teams responsible for registration data.
Updated: 9 September 2026 · Editorial team: VALNARO AG
Actors and mandates
Check CHRN and roles. For manufacturers abroad, review the CH-REP and mandate. The responsible person needs appropriate registry access. An EU SRN does not replace a Swiss CHRN.
Device data and upload
Inventory devices and UDI-DIs. Check data against the current swissdamed Data Dictionary. EUDAMED data can provide a starting point; do not assume automatic synchronisation between registries.
After registration
Reconcile registration status and errors. Feed changes from product and quality processes into registry maintenance. Keep traceable evidence of review and approval.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.
Download checklistREGULATORY / CH & EU
swissdamed: clarify data and responsibilities
Updated: 9 September 2026 · Editorial team: VALNARO AG
EUDAMED
The first four modules have been mandatory since 28 May 2026. For certain previously marketed devices, the EU timeline gives 28 November 2026 as the registration deadline. New devices and certificates have separate rules.
Responsibilities before interfaces
Review UDI and actor data, mandates and approvals together. Registration in EUDAMED does not replace registration in swissdamed. MDR/IVDR and the Swiss MedDO/IvDO are distinct legal frameworks.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.
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