关键词: 医疗器械, 安全警戒系统, 不良事件

Abstract: By introducing the goals and changesof the EU 2009 edition of "GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM", to analyse and explain the two signals delivered by the Guidelines. Then it describes the control objects of the Guidelines, the responsibilities of all parties in the Medical Devices Vigilance System, and the top concern problems, by the medical devices manufacturers, such as the report range of medical devices adverse events and the due time of the reports in detail.

Key words: medical devices, vigilance system, adverse event