《医疗器械安全和性能的基本原则》的应用探讨:以关节假体产品为例

Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices:Take Artificial Joint Products as Example

通过有效应用《医疗器械安全和性能的基本原则》(以下简称《基本原则》),帮助监管部门和生产企业在质量管理体系、风险管理体系和产品安全有效性评价等方面不断完善相应管理手段,确保产品的安全性及有效性。该研究通过分析《基本原则》的应用现状及存在的问题,以关节假体产品为例,从质量管理体系、风险管理体系和产品安全有效性评价等方面研究《基本原则》的应用思路,并提出相关思考。监管部门应加强对《基本原则》的统一认识,基于医疗器械产品类别分别制定要求,并细化具体执行要求。

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(EP),to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system,risk management system,evaluation of safety and effectiveness for the supervision departments and manufacturers.The current status of the application of EP and the application issues are analyzed in the study.Take artificial joint products for example,the idea of using EP in quality management system,risk management system and evaluation of safety and effectiveness is investigated,and several thoughts are proposed.Supervision departments should strengthen the unified understanding of EP,develop requirements according to the classification of medical device,and refine specific execution requirements.