On December 23, the Eurasian Economic Commission’s Board meeting adopted the Methodological Recommendations on the content and structure of the documents of the marketing authorization application of a medical device and the examination of safety, quality and efficiency of medical devices for the purpose of their marketing authorization.
Taking into account the law enforcement practice, the Methodological Recommendations define approaches to the expert examination of safety, quality and efficiency of medical devices, as well as unify approaches to the type and content of evidentiary materials (documents) of a medical device manufacturer submitted for expert examination to provide proof of the safety and efficiency of a medical device and prepare its marketing authorization application in accordance with the Rules for Registration and Expert Examination of Safety, Quality, and Efficiency of Medical Devices.
The Methodological Recommendations have been developed to replace the Methodological Recommendations on the Examination of Safety, Quality and Efficiency of Medical Devices for the Purpose of their Marketing Authorization within the EAEU and the Methodological Recommendations on the Content and Structure of Documents of the Marketing Authorization Application of a Medical Device adopted by the Commission in 2019.