DMR文件和DHF文件
MDR法规
1、理事会第 90/385/EEC 号指令（ 3 ）和理事会第 93/42/EEC 号指令（ 4 ）构成有关医疗器械（不包括体外诊断医疗
器械）的欧盟监管框架。但需要对该指令进行大幅修订，以便建立稳健、透明、可预测和可持续的医疗器械监
管框架，以确保高水平的安全和健康，同时为创新提供支持。
翻译：Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory
framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental
revision of those Directives is needed to establish a robust, transparent, predictable and sustainable
regulatory framework for medical devices which ensures a high level of safety and health whilst supporting
innovation.
单词扫盲
directive：指令
Council：委员会
supervise：监管
regulatory:监管的；(对工商业)具有监管权的;
framework：框架
revision：修订
robust：稳固；强健的
whilst：同时
2、本法规并不寻求协调有关医疗器械投入使用后，在市场上进一步供应之规则，例如二手销售。
翻译：This Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.
单词扫盲
harmonise：协调
available：可获得的
second-hand sales：二手销售
3、应大大加强现有监管方法的关键要素，例如公告机构监管、符合性评估流程、临床研究和临床评价，警戒和市场监管，同时引入确保医疗器械透明度和可追溯性之规定，以改善健康和安全性。
翻译：Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.
单词扫盲
elements：要素
existing：现行的；现有的
conformity assessment procedures：符合性评估流程
clinical investigations：临床研究；临床调查
clinical evaluation：临床评价
vigilance：警戒
surveillance：监管；监督
provisions：规定
transparency：透明度
traceability：可追溯性
总结
持续学习英语是做国际注册很重要的一种能力，本公众号秉承初心，为了更好的为医疗器械注册人进行知识输出，开设了本专题，如果你有兴趣的话，快来加入我们一起打卡吧，后续我们会持续更新，敬请期待！
医械香猪
