标准科学Issue(2)：138-140,3.DOI:10.3969/j.issn.1674-5698.2018.02.026
欧盟新版法规文件(EU)2017/745关于诊断医疗设备指令及其影响分析
Analysis of EU New Legislation Document (EU) 2017/745 Directive on Diagnostic Medical Device and their Impacts
摘要
Abstract
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.关键词
技术性贸易措施/医疗器械/指令/MDRKey words
Technical Barriers to Trade (TBT)/medical devices/directive/MDR引用本文复制引用
施亚申,扈罗全,周有良..欧盟新版法规文件(EU)2017/745关于诊断医疗设备指令及其影响分析[J].标准科学,2018,(2):138-140,3.
