欧盟医疗器械上市程序及对审评工作启示

欧盟的医疗器械管理体系较为完备,具有很多值得借鉴的经验特点。该文简单概述医疗器械在欧盟的上市过程,内容包括三个核心医疗器械指令、获取CE标志过程、医疗器械警戒系统和对获取CE标志后的管理等。同时,初步探讨了欧盟医疗器械监管对我国医疗器械技术审评工作的一些启示,以供监管部门、技术审评单位和制造商参考。

The EU Medical Device Market Process and Enlightenment for the Review

European Union （EU） medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices＇ technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.