The software qualification under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) receives new guidance from the European Commission's Medical Device Coordination Group (MDCG).
The guidance addresses various types of software, which will provide decision-triggering information such as, blood glucose meter software, on an immediate basis. These types of software are classified under the MDR or IVDR, and it will provide support for the health professional, e.g., electrocardiogram interpretation software.