欧盟关于医疗机构内部器械指南及其监管思路探讨

Discussion on European Union Health Institution In-House Device Guidance and Its Regulatory Ideas

目的:探讨欧盟医疗机构内部器械监管思路,为我国相关工作提供研究基础和参考。方法:解析欧盟医疗器械协调组最新医疗机构内部器械法规和指南文件,探讨其法规框架背景、监管思路以及对我国的借鉴意义。结果与结论:欧盟通过系列文件,建立并阐明了其内部器械的监管要求和实施思路,基础概念清晰,适用范围明确,可操作性强,对进一步完善我国相关监管思路具有重要借鉴意义。

Objective:Exploring the regulatory ideas of health institution in-house devices in European Union,to provide research basis and reference for related work in China.Methods:Analyzed latest health institution in-house devices regulations and guidance of the Medical Device Coordination Group,discussing its regulatory framework background,regulatory ideas and the reference significance to our country.Results and Conclusion:Through these documents,European Union has established and clarified its health institution in-house devices regulatory requirements and implementation ideas,its basic concept is unambiguous,scope of application is clear,and operability is strong,and it has an important reference significance for further improving the relevant regulatory ideas in our country.