CAJ | 학술논문

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。
구맹적의료기계관리체계교위완비，구유흔다치득차감적경험특점。해문간단개술의료기계재구맹적상시과정，내용포괄삼개핵심의료기계지령、획취CE표지과정、의료기계경계계통화대획취CE표지후적관리등。동시，초보탐토료구맹의료기계감관대아국의료기계기술심평공작적일사계시，이공감관부문、기술심평단위화제조상삼고。
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.