19
Dec
By Irene Picciano and Elisa Stefanini of Portolano Cavallo Studio Legale
In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”). The Guidance aims at providing clarification to medical software manufacturers with respect to (i) qualification issues (when software is considered a device); and (ii) classification issues, depending on...