What applies now
Four EUDAMED modules have been mandatory since 28 May 2026. For certain existing devices, the transitional device-registration deadline is 28 November 2026. Product registration in swissdamed has been mandatory since 1 July 2026; affected products already on the market have a transition period until 31 December 2026.
Why a portal is not enough
Registrations depend on data distributed across ERP, PLM, documents, spreadsheets and local responsibilities. Without a clear data model, teams create duplicate maintenance, inconsistent values and approvals that are hard to trace.
A dependable path
Regulatory Information Management connects data objects, roles, dossiers, validation and changes to the Digital Thread. Submissions are prepared from controlled sources instead of being assembled manually near a deadline.
The DPP connection
The same foundation can be extended for the Digital Product Passport with material, supplier, sustainability and public product information. Structuring regulatory data now creates a reusable part of the DPP foundation.