Regulatory and risk oriented approach to the design and development of medical devices in accordance with Ukraine regulations

Abstract

Based on the interpretation of regulatory requirements to describe the approach to risk-oriented medical devices design and development strategy and approaches to their certification in Ukraine market. The approach to the medical devices design and development strategy is described taking into account the classification by level of risk; a tree of decisions on determining the risk class and certification of medical devices according to the requirements of the Technical Regulation № 753 is presented.