Swissmedic Updates swissdamed User Guide for the UDI Devices Module
Swissmedic has updated its swissdamed User Guide for the UDI Devices Module, including guidance on UDI registration, market status, M2M, Master UDI-DI and legacy devices.
Swissmedic publishes updated swissdamed Playground User Guide
Swissmedic has published Version 3.0 of the swissdamed User Guide – Playground, providing updated instructions for testing actor registration and UDI management before using the production environment.
Swissmedic Publishes Version 2.0 of the swissdamed UDI Data Dictionary
Swissmedic has published Version 2.0 of the swissdamed UDI Data Dictionary, introducing new data elements and clarifying requirements for the registration and management of UDI information for medical devices in Switzerland.
Swissmedic Publishes Guidance on the Procurement of Medical Devices in Healthcare Institutions
Swissmedic has published Version 6.0 of its Information Sheet – Procurement of Medical Devices in Healthcare Institutions, providing guidance on the procurement of medical devices and IVDs in Switzerland, including conformity documentation, certificate verification and the use of swissdamed.
Swissmedic Publishes User Guide for the swissdamed UDI Devices Module
Swissmedic has published Version 3.0 of the swissdamed User Guide – UDI Devices Module, introducing new functionalities for device registration and management, including Machine-to-Machine (M2M) processes, manual UDI-DI management and Master UDI-DI requirements.
Swissmedic Publishes swissdamed Business Rules Version 4.0
Swissmedic has published swissdamed Business Rules Version 4.0, introducing new Master UDI-DI requirements, UDI registration rules, and data management obligations for medical device manufacturers in Switzerland.
Swissmedic Updates swissdamed Actors User Guide: What Manufacturers and Authorised Representatives Should Know
Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.
Swissmedic Updates swissdamed UDI Data Dictionary
Swissmedic has published version 3.0 of the swissdamed UDI Data Dictionary, introducing clarifications to SRN fields and new machine-to-machine attributes for improved data mapping.
Swissmedic Publishes swissdamed Machine-to-Machine REST API Documentation (Version 1.0)
Swissmedic publishes Version 1.0 of the swissdamed Machine-to-Machine REST API documentation for UDI registration and market status management.
Swissmedic Updates swissdamed Business Rules – Key Changes for Device Manufacturers in 2026
Swissmedic has released version 3.0 of its swissdamed Business Rules, effective January 2026. The update includes stricter UDI-DI requirements, limits on legacy device data, and mandatory fields for MDR/IVDR submissions. Manufacturers must now align with Swiss-specific data rules diverging from EUDAMED.