Literature Review of Guidelines for Medical Devices Assessment

Abstract

Background. Research on the development and implementation of new principles and methods applicable in the evaluation of medical devices (MD) will allow to accumulate new, as well as the most effective long-used and proven approaches to the clinical and economic evaluation of such an important and extensive class of medical technologies.Aims. The aim of the study is to identify and analyze developed, approved recommendations for the assessment of MD in the world and domestic practice of assessing health technologies, as well as to find and summarize the current principles, optimal proven and innovative methods for assessing MD for the draft modern recommendations for MD assessment in Moscow.Materials and methods. The sources of the study were scientific articles on the topic of MD assessment and recommendations published over the past five years.Results. A review of publications revealed disunity in the approaches to assessing MD according to international sources, as well as the lack of unified agreed recommendations in Russia. A number of problems and aspects that need to be taken into account when formulating uniform recommendations are clearly defined.Conclusion. It is obvious that there is a need to formulate and adopt clear recommendations on the assessment of medical technologies (HTA) of MD, taking into account positive international experience.