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 2019-11 Rev.1 - New guidance on qualification and classification of software as a medical device or in vitro diagnostic medical device
The new revised version of the MDCG 2019-11 (Rev.1) clarifies the qualification and classification of software as a medical device (MDSW ) and in vitro diagnostic software (IVD), in the context of the MDR and IVDR. The document covers classification rules, integration with AI Act and EHDS, and includes practical and up-to-date examples. Smart MDR supports MDSW manufacturers in managing compliance and technical documentation.