2017/745 - EN - Medical Device Regulation - EUR-Lex
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and …
EU MDR vs. MDD: Key differences [Infographic] - Advisera
2020年11月24日 · See how EU MDD and MDR compare, what is the transition period, and what are the main similarities and differences you should be aware of.
MDD vs MDR - Understanding the difference | Kobridge
What is the EU Medical Device Regulation (MDR)? The Medical Device Regulation (MDR) was established in 2007 and then revised for the first time in 2017. It is the successor of MDD and applies to manufacturers of medical devices sold or exported into Europe, excluding products used inside the EU but may include those marketed outside it.
医疗器械新法规MDR和MDD指令有什么区别？ - 知乎专栏
2017年5月5日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）。 MDR将取代Directives 90/385/EEC （ 有源植入 类医疗器械指令）and 93/42/EEC（医疗器械指令）。
MDR 与 MDD 法规下医疗器械分类的区别 - 搜狐
2024年12月17日 · 2017 年 5 月 5 日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称 “MDR”）。 其目的在于确保更好地保护公众健康和患者安全，旨在加强对医疗器械全方位的监管与控制，保障医疗器械在整个生 …
欧盟CE（MDR）是什么？ - 知乎专栏
MDR CE是什么？ 欧盟医疗器械法规（Medical Device REGULATION (EU) 2017/745，简称“MDR”） 贵司产品在做欧盟CE认证的时候，属于医疗器械，现在欧盟执行的医疗器械CE法规，就是MDR，办理CE时要求按照新法规 MDR …
MDR vs. MDD: 13 Key Changes - The FDA Group
2022年6月17日 · The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been set back one year to May 26, 2021. The amending EU-MDR Regulation 2020/561 offers a wealth of detail impacted manufacturers should understand and act on now .
Regulation (EU) 2017/745 - Wikipedia
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on …
Key Differences Between EU MDR and MDD - i3cglobal.com
2025年2月18日 · The transition from MDD to EU MDR has introduced more rigorous and detailed requirements for demonstrating the equivalence of medical devices. The MDR places a stronger emphasis on comprehensive evidence, including technical, biological clinical characteristics, while also demanding stricter documentation and justification for equivalence claims.
The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175