关键词: 欧盟, 医疗器械, 警戒系统, 2017/745号医疗器械法规, 风险管控

Abstract: Objective To provide reference for the establishment of medical device vigilance systems in China by analyzing the responsibilities and requirements of the medical vigilance system in the amendments to European Union(EU) medical device regulations. Methods The advantages of the EU medical device vigilance system were analyzed and compared with the monitoring of medical device adverse events in China. Results The medical device vigilance system was critical to risk management of the whole life cycle of medical devices and to the safety of the public. Conclusion Ways to improve medical device vigilance in China are suggested by learning from the experience of European Union and based on the current monitoring practices of medical device adverse events in China

Key words: European Union, medical device, vigilance system, MDR, risk control