State registration of software as a medical device according to the rules of the Eurasian Economic Union (EAEU)

ABSTRACT

The Russian Federation together with Kazakhstan, Kyrgyzstan, Armenia and Belarus has been working to create a single market for medical devices including special software in the Eurasian Economic Union (EAEU) since January 01, 2015. A large work has been done to improve legal regulation of state registration of software products based on the recommendations of the International Medical Device Regulators Forum (IMDRF).

The purpose of this report was to analyze the regulatory requirements for registration of software medical devices according to the EAEU rules, as well as to describe the features and duration of quality assessment and registration. The important features of registration of software medical devices according to the EAEU rules compared to registration in accordance with national rules are requirements for quality management system, different approaches to clinical trials and methods for obtaining clinical data. There is still no practice of registration of software medical devices according to the EAEU rules. Therefore, there are some problems associated with insufficient competencies in clinical trials of medical software products, the lack of validated databases for such trials, as well as clear requirements for preparing and conducting trials. In this manuscript, the authors formulate certain proposals for improvement of regulatory legal acts and recommendations in state
registration of medical software medical devices according to the EAEU rules.