欧盟医疗器械上市后风险趋势分析方法研究

目的研究医疗器械上市后风险评估的统计学方法,提高风险管理的科学水平。方法参考欧盟医疗器械新法规中即将实施的趋势报告要求,探索趋势分析方法在医疗器械上市后风险评估中的实践运用,举例说明通过历史数据确定控制限和持续趋势监测的过程,讨论实践中面临的问题。结果趋势分析是科学评估医疗器械上市后风险的方法之一,适于在国内推行。结论企业可运用真实世界风险数据开展趋势分析,提升上市后风险预警能力。

Methods for risk trend analysis of EU post-marketing surveillance for medical devices

Objective To improve the level of risk management based on a study of statistical methods for post-marketing risk assessment of medical devices.Methods The applications of trend analysis methods for post-marketing risk assessment of medical devices were explored by reference to the trend reporting requirements in the new EU medical device regulations.The process of determining the control limits and continuous trend monitoring via historical data was analyzed by examples,and related problems were discussed.Results Trend analysis was one of the methods for scientifically evaluating the risks of post-marketing medical devices,and it could be implemented in China.Conclusion Manufacturers can use real-world risk data to carry out trend analysis and improve the ability to warn against post-marketing risks.