New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components

The Medical Device Coordination Group (MDCG) endorsed a new guidance document, MDCG 2023-4, on Medical Device Software (MDSW) - Hardware combinations, as guidance on MDSW intended to work in combination with hardware or hardware components. For more, see the Commission’s webpage on Guidance.