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.

Release 3.22 of the EUDAMED UDI/Devices User Guide provides updated guidance on MDR and IVDR device registration, UDI requirements, EMDN codes and lifecycle management for manufacturers.

The new EUDAMED user guide for Unique Identifier (UDI) devices is an indispensable reference for all medical device manufacturers who want to ensure compliance with the MDR and IVDR regulations. The document covers aspects such as registering Basic UDI-DI and UDI-DI, managing data in EUDAMED, connecting to legacy devices, and updating versions. It also includes crucial information on requirements for accessing the EUDAMED platform, user profiles, and the procedures for structured data submission. This guide is essential for ensuring an effective compliance strategy in the European regulatory context.