IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Introduction and Consideration

Abstract

IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (hereinafter referred to as "EP"), which further promoted the unification of medical device safety and effectiveness internationally. In order to strengthen the scientific review of medical device and deepen the understanding of EP, we introduce EP, focus on the role of EP and the connection with the construction of quality management systems, risk and benefit determination, and registration, analyze the problems and reasons in the process of medical device registration, and give suggestions to promote the application of EP.