KEY MESSAGE
关键信息
- EUC published a fact sheet on MDR requirements for Transparency and Public Information, which includes what data will be publicly available from EUDAMED.
欧盟委员会公布了一份关于MDR透明度和公共信息要求的情况说明，其中包括了欧盟医疗器械数据库将公开提供哪些数据。 - What is the state of play of the implementation of EUDAMED?
欧盟医疗器械数据库的执行情况如何？ - Commission has confirmed its readiness to deploy the actor registration module of EUDAMED as of 1 December 2020, but will be on voluntarily basis until EUDAMED is fully functional.
委员会已确认准备从2020年12月1日起配置欧盟医疗器械数据库的模块，但在欧盟医疗器械数据库完全发挥作用之前，将以自愿的原则进行。 - Covid-19 Impacts on the NB operations.
新型冠状病毒影响NB运作。 - IMDRF terminologies for categorized Adverse EventReporting (AER): terms, terminology structure and codes are updated
http://www.imdrf.org/documents/documents.asp.
Note that it is mandatory both under regulation and directive from 20th of April 2021
国际医疗器械监管机构论坛关于不良事件分类报告(AER): 术语、术语结构和代码更新详见：http://www.imdrf.org/documents/documents.asp
请注意，从2021年4月20日起，这在法规和指令下都是强制性的。 - ISO 14155:2020 Clinical investigation of medical device for human subjects has been published and are available at SIS.
ISO 14155:2020 《医疗器械临床实验管理规范》已经出版，可在SIS查阅。 - ISO/TR 20416:2020 Medical device - Post market surveillance for manufacturers has been published and are available at SIS.
ISO/TR 20416:2020《医疗器械制造商的上市后监督》已经出版，可在SIS查阅。 - (EU) 2020/437 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC.
支持理事会93/42/EEC号指令而起草的关于医疗器械协调性标准（欧盟）2020/437。 - The first Client Newsletter has been published on our website.
**份客户简讯已经在我们的网站上发布。 - MHRA published a guidance on UK Medical regulation in context of Brexit:
https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021. IMNB have published a statement on the global and local website, follow this link.
MHRA发表了英国退欧背景下医疗法规指南：https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021. IMNB已在全球和当地网站上发表声明，请点击此 链接。 - Commission Implementing Regulation (EU)
2020/1207 laying down rules for the application of Regulation (EU) 2017/745 as regards to common specifications for the reprocessing of single-use devices. For our assessment please follow the link.
委员会为法规(EU) 2017/745中关于一次性设备再处理的通用规范应用制定了(EU)2020/1207，有关我们的评估指导原则，请点击链接。 - Released MDCG’s, Standards and Regulations affecting the NB operations.
医疗器械协调小组发布了指导NB运作的标准和法规。 - Switzerland one step closer to recognize MDR.
瑞士向MDR认可又迈进了一步。
MDCG GUIDANCE DOCUMENTS
医疗器械协调小组指导文件
The Table below shows specific MDCG guidance documents that has an impact on your work and responsibilities. If you are interested in getting more detailed information of the specific guidance please click on √. For the complete list of all published MDCG’s please follow this
下表显示了对您的工作和职责有影响的具体医疗器械协调小组指导文件。如果您有兴趣了解详细的具体指导信息，请点击
REGULATIONS & DECISIONS
法规和决定
The Table below shows regulation/EUC/Team NB relative information that impact your work and responsibilities. If you are interested in getting more detailed information on the regulations or the EUC, Team NB or others please click on √.
下表显示了影响法规/欧盟委员会/公告机构协会的相关信息。如果您有兴趣了解更多关于法规或欧盟委员会、公告机构团队等其他的详细信息，请点击√。
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