2016 № 3 About the definition of the classes of potential risk of medical software
Describes the Nomenclature classification of medical devices (MD). Lists the problems related to the inclusion of software in the nomenclature of the types of MD. Proposed criteria for Software as a Medical Device (SaMD). The proposed classification of SaMD based on potential risk to the health of the patient. Describes the rules for identifying these risks and determining the risk class for SaMD.