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
EUDAMED & swissdamed: data readiness
Two registries, shared source data. Start with product records and responsibilities before automating an export.
Updated: 9 September 2026 · Editorial team: VALNARO AG
1. Clarify portfolio and roles
Which products and markets are affected? Assign manufacturer, authorised representative, importer and internal approval roles. Keep actor and device registration distinct.
2. Compare the data
Collect UDI, classification, trade names, packaging and evidence from PLM, ERP and RIM. Document field mapping, required fields, languages and permitted values for each registry.
3. Test one complete case
Review one representative device case, transfer it through an authorised test process and evaluate responses. Then expand the scope. Assign responsibility for changes and registry feedback.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.
REGULATORY / 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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