摘要
全球医疗器械行业保持着快速稳定的增长。欧洲作为我国的主要贸易地区,在2017年相继发布新的医疗器械法规文件,对医疗器械加强管控,形成了新的技贸措施。本文介绍了医疗器械(MDR)(EU)2017/745指令正文概要,分析了指令中的医疗器械分类和数据保护,并分析了该指令的可能的影响。
The global medical device industry maintains rapid and steady growth. Europe as China＇s major trading region has released new medical device regulatory document in 2017 to step up its control over medical devices and form new technological and trade measures. This paper introduces the main document of the MDR（EU） 2017/745 Directive, analyzes the classification of medical devices and data protection in the directives, and analyzes the possible imparts of the directive in details.
出处
《标准科学》
2018年第2期138-140,共3页
Standard Science
关键词
技术性贸易措施
医疗器械
指令
MDR
Technical Barriers to Trade （TBT）, medical devices, directive, MDR
