KEY MESSAGE
關鍵信息

• EUC published a fact sheet on MDR requirements for Transparency and Public Information, which includes what data will be publicly available from EUDAMED.
  歐盟委員會公布了一份關于MDR透明度和公共信息要求的情況說明，其中包括了歐盟醫療器械數據庫將公開提供哪些數據。
• What is the state of play of the implementation of EUDAMED?
  歐盟醫療器械數據庫的執行情況如何？
• 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.
  委員會已確認準備從2020年12月1日起配置歐盟醫療器械數據庫的模塊，但在歐盟醫療器械數據庫完全發揮作用之前，將以自愿的原則進行。
• Covid-19 Impacts on the NB operations.
  新型冠狀病毒影響NB運作。
• 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
  國際醫療器械監管機構論壇關于不良事件分類報告(AER): 術語、術語結構和代碼更新詳見：
  http://www.imdrf.org/documents/documents.asp
  請注意，從2021年4月20日起，這在法規和指令下都是強制性的。
• ISO 14155:2020 Clinical investigation of medical device for human subjects has been published and are available at SIS.
  ISO 14155:2020 《醫療器械臨床實驗管理規范》已經出版，可在SIS查閱。
• ISO/TR 20416:2020 Medical device - Post market surveillance for manufacturers has been published and are available at SIS.
  ISO/TR 20416:2020《醫療器械制造商的上市后監督》已經出版，可在SIS查閱。
• (EU) 2020/437 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC.
  支持理事會93/42/EEC號指令而起草的關于醫療器械協調性標準（歐盟）2020/437。
• The first Client Newsletter has been published on our website.
  **份客戶簡訊已經在我們的網站上發布。
• 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發表了英國退歐背景下醫療法規指南：https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021. IMNB已在全球和當地網站上發表聲明，請點擊此鏈接。
• 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.
  委員會為法規(EU) 2017/745中關于一次性設備再處理的通用規范應用制定了(EU) 2020/1207，有關我們的評估指導原則，請點擊鏈接。
• Released MDCG’s, Standards and Regulations affecting the NB operations.
  醫療器械協調小組發布了指導NB運作的標準和法規。
• Switzerland one step closer to recognize MDR.
  瑞士向MDR認可又邁進了一步。

MDCG GUIDANCE DOCUMENTS
醫療器械協調小組指導文件

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 Link.
下表顯示了對您的工作和職責有影響的具體醫療器械協調小組指導文件。如果您有興趣了解詳細的具體指導信息，請點擊√。所有公布的MDCG的完整列表請點擊這個鏈接。

REGULATIONS & DECISIONS
法規和決定

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 √.
下表顯示了影響法規/歐盟委員會/公告機構協會的相關信息。如果您有興趣了解更多關于法規或歐盟委員會、公告機構團隊等其他的詳細信息，請點擊√。

如您需要閱讀全文內容，請點擊這里。