欧盟公告机构用医疗器械类别新框架研究

目的：分析欧盟公告机构用医疗器械类别新框架，为建立我国医疗器械行业相关监管法规提供借鉴和参考。方法：对比分析欧盟医疗器械监管新法规体系下指定公告机构用产品类别新框架与原框架的异同，分析新框架与新法规体系下分类规则、命名系统的相关性。结果和结论：欧盟公告机构用医疗器械类别新框架使公告机构指定范围的划分更为精准合理，新框架中相关条目与分类规则、命名系统的整体化设计思路体现了欧盟整体协调一致的监管法规系统的工作思路。

Overview of the New Framework for Medical Device Categories Used by the EU Notified Body

Objective:To analyze the new framework for medical device categories used by the European Union (EU) notified body and provide references for establishing the relevant regulations for the medical device industry in China. Methods:The similarities and differences between the new and the original frameworks of the product categories used by the EU notified body under the new EU medical device regulatory system were compared and analyzed. The correlation between the classification rules and nomenclature system under the new framework and regulatory system was analyzed. Results and Conclusion:The new framework for medical device categories used by the EU notified body makes the division of the designated scope of the notified body more precise and reasonable. The relevant items, classification rules and nomenclature system in the new framework have reflected the working ideas of the overall coordinated regulatory system in EU.