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.
2019 № 3 About the classification of risks of application of the medical software in the Eurasian economic union
The rules of classification of risks of medical software – Software as a Medical Device (SaMD), adopted by the International forum of regulators of medical devices (IMDRF), the Eurasian economic Union (EAEU) and the European Union (EU). Formal models of these rules are described. A comparative analysis of the risk classes of SaMD is done, examples of which are described in the documents IMDRF, defined by these rules.