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.

The MHRA has released an update on the registration of medical devices in the UK, specifying the requirements for domestic and international manufacturers. The MHRA reinforces the need for compliance with the new surveillance and registration requirements, ensuring that medical devices and IVDs meet UK regulatory requirements before they are placed on the market.

MDCG 2025-1 introduces an ad hoc procedure form to facilitate the updating of the European Medical Device Nomenclature (EMDN). This document is crucial for manufacturers, national competent authorities (NCAs) and notified bodies (NBs) that need to register devices in the UDI-DI module of EUDAMED. The new approach allows proposals for new codes to be submitted when existing ones are insufficient, promoting the registration of innovative technologies and regulatory compliance. This initiative by the Medical Device Coordination Group (MDCG) contributes to standardisation and clarity in the medical device sector in the European Union.