Swissmedic Publishes Updated Information Sheet on Medical Device Software (Version 3.0)
Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.
EU Borderline & Classification Manual (Version 5 – April 2026): What Manufacturers Need to Know
New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.
MDCG Publishes Updated Guidance on Medical Device Classification (MDCG 2021-24 Rev.1)
MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.