基于真实世界数据的高风险植入类无源医疗器械上市后风险监测技术专家共识

高风险植入类无源医疗器械的上市后监测是医疗器械风险管理的重要环节,通过对高风险医疗器械上市后安全性信号的监测和评价,最大限度地控制医疗器械潜在的风险,保证医疗器械安全、有效地使用,避免发生群体性严重后果,是医疗器械生产、经营、使用机构和技术监测部门的共同职责.为了更好地促进和辅助高风险植入类无源医疗器械的上市后监测,本...

Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data

Post-market surveillance of high-risk implantable passive medical devices is one of key aspects in the risk management of medical device.It is the common responsibility of medical device industry,operations,user institutions and regulatory departments to control the potential risks of medical devices to the maximum extent,and ensure the safe and effective use of medical devices and avoid mass serious consequences,which can be achieved by post-market surveillance and evaluation management of safety signals of high-risk medical devices.In order to promote and assist the post-market surveillance of high-risk implantable passive medical devices,by systematic literature review,focus group discussion and expert consultation,this expert consensus systematically reviewed the status quo of post-market surveillance of risk among medical devices home and board,further constructed the mode of risk monitoring of high-risk implantable passive medical device and key technologies which could be suitable for China’s national conditions.