Implementing regulation - 2021/2226 - EN - EUR-Lex
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226. of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of …
Medical Device Regulation comes into application
2021年5月26日 · Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The Medical Device Regulation (MDR), which was …
It can reduce the environmental burden and reduce costs for the medical device industry while maintaining or improving the level of safety.
New Regulations - European Commission - Public Health
The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also …
Guidance - MDCG endorsed documents and other guidance
This page provides a range of documents to assist stakeholders in applying: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …
Download MDR - Medical Device Regulation
MDR Guidances and Tools. Download the free MDR Gap Analysis Tools. Check latest MDCG. Check guidance documents from EU and Notified Bodies. Review the list of Meddev …
MDR CE技术文件全攻略：七大模块助您轻松应对欧盟新规！
自2021年5月26日起，欧盟医疗器械法规（mdr）正式实施，医疗器械制造商在申请ce认证时，必须按照mdr法规提交技术文件，并每年更新。这一变化对企业的技术文件管理提出了更高要求 …
Regulation (EU) 2017/745 (EU MDR)
Update of MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC …
美国FDA与欧盟MDR在医疗器械的法规要求上有什么区别？
2025年2月18日 · 而欧盟方面，mdr（医疗器械法规）自2021年5月起正式施行，取代了旧的mdd（医疗器械指令），为医疗器械在欧洲市场的上市设定了新的基准与要求。 两大核心市 …
欧盟医疗器械法规MDR正式执行，这些变化需关注 - 中国食品药品网
2021年5月26日，欧盟医疗器械法规MDR（EU2017/745）正式强制执行。 新规有哪些变化？ 面对这些变化，国产医药器械厂商在申请CE认证时需要注意的点有哪些？ 对于之前已经申请CE认 …