The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1 under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the Guidance, available here). The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification).
Under the currently applicable rules, supported by guidance set out in MEDDEV 2.1/6,2 most software devices are classified as low risk. However, the new classification rules set out in the MDR, in particular Rule 11, significantly change the classification of MDSW, with many software devices to be generally considered medium- or even high-risk devices.
Here we examine which areas have been clarified by the Guidance and which topics remain open to interpretation.