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 new version of the MIR 7.3.1 form, published by the European Commission, brings relevant changes for manufacturers of medical and in vitro diagnostic devices. The updated form is mandatory in the context of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and is aligned with post-market surveillance (PMS) requirements and the future use of the EUDAMED system. Manufacturers must ensure that they use the new MIR model, with updated fields, IMDRF coding, EMDN nomenclature and structured data such as UDI-DI, Basic UDI and SRN.