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 Highlights Critical Deficiencies in Notified Body Opinions for Integral Combination Products
Swissmedic’s review of Notified Body Opinions under MDR Article 117 reveals major gaps in documentation quality for drug–device combination products. Updated expectations now apply to ensure compliance with GSPRs.