欧盟医疗器械临床评价详解与思考

Understanding and thinking on medical devices clinical evaluation in European Union

目的:探讨欧洲联盟(以下简称"欧盟")的医疗器械临床监管现状,为国家医疗器械产品注册申请人与监管人员在临床试验方面提供参考。方法:通过介绍欧盟的医疗器械临床研究监管法规、临床评价的路径及临床研究的审批过程,了解欧盟的医疗器械临床监管现状及要求,并对临床研究的时机等技巧进行分析。结果:通过对比国内临床评价监管要求,分析了国内临床评价监管出现的问题,并提出建议。结论:了解和借鉴欧盟医疗器械临床研究监管法规,可对我国医疗器械临床试验科学监管水平的提高提供参考。

Objective To improve the medical device product registration applicant and supervisor＇s understanding of clinical trials by discussing medical devices clinical supervision in European union.Methods European Union＇s medical device supervision regulation of clinical research was introduced,the path of clinical evaluation and the approval process of clinical research were explained in detail,and the timing of clinical research was analyzed.Results The requirements and problems of China clinical evaluation supervision were explored,and some suggestions were put forward accordingly.Conclusion To understand and learn from European Union medical device clinical research regulatory laws and regulations improves the level of medical device clinical trials scientific supervision in China.