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歐盟委員會更新了MDR/IVDR實施的工作計劃
來源: | 作者:SUNGOGROUP | 發布時間: 48天前 | 89 次瀏覽 | 分享到:

歐盟委員會(EC)對歐盟醫療器械法規(REGULATION (EU) 2017/745,簡稱“MDR”)和歐盟體外診斷醫療器械法規(REGULATION (EU) 2017/746,簡稱“IVDR”)的滾動實施計劃進行了更新,并交代了部分舉措所取得的進展。  


該滾動計劃對1月份發布的概況介紹進行了說明。這些概況介紹的目標受眾包括:授權代表、進口商、分銷商、非歐盟/歐洲經濟區(EEA)國家主管當局以及醫療器械和體外診斷采購生態系統(包括醫院和診所)的相關人員。這些可交付成果是該計劃宣傳活動的一部分,旨在避免“瓶頸”出現,并確保醫療器械的可及性。


除了一系列新的概況介紹外,歐盟委員會上個月還發布了信息圖表和2020/2022年過渡時間表,以便幫助相關企業機構為應對新增的監管要求做準備。

 

醫療器械協調小組(MDCG)于2017年成立,旨在為MDR/IVDR滾動計劃中概述和定期更新的基本執行行為(實施細則)和措施提供方向指引。該小組也發布了一系列新的指南文件。歐盟委員會于最近兩個月(即1月和2月)發布的兩份指南文件包含證書和證書自愿轉讓情況,以及醫療器械的唯一器械標識(UDI)規則的應用情況。上個月,MDCG針對簽發實體發布了關于基本UDI-DI[直接標記]要求的指南文件。


在那些未來需要用調查結果來支持執行行為草案的領域,醫療器械協調小組(MDCG)成員的調查目前已進入“完結”狀態,這包括與專家小組有關的事宜,包括費用、歐盟基準實驗室和專家實驗室以及與歐洲醫療器械數據庫(Eudamed)相關的詳細信息。歐盟在2018年10月發布MDR/IVDR實施的工作計劃之際,上述調查還處于“進行中”的狀態。


MS和Cen/Cenetec關于標準化授權范圍的討論協商現已完成。


關于無醫療用途產品通用規范的執行行為現已推遲施行。該執行行為原定于2018年第三季度施行,隨后推遲到2019年初,現又推遲到2020年第一季度。

滾動計劃將在MDR/IVDR過渡期間每季度進行一次更新審查。


英文原文


EC Updates EU MDR/IVDR Implementation Rolling Plan


The European Commission (EC) updated the rolling implementation plan for the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), noting progress with certain initiatives.


The rolling plan points to fact sheets published in January. These were addressed to authorized representatives, importers, distributors, authorities in non-EU/EEA states and those involved in the procurement ecosystem for medical devices and IVDs, which include hospitals and clinics. The deliverables were developed as part of the plan’s communication campaign intended to “avoid bottle necks” and ensure medical device access.


In addition to the string of new fact sheets, EC also posted infographics and 2020/2022 transition timelines last month to aid in preparations for the increased regulatory requirements.


The Medical Device Coordination Group (MDCG), which was established in 2017 to help guide the direction of the essential implementing acts and actions outlined and routinely updated in the MDR/IVDR rolling plan, issued a set of new guidance documents as well. These two guidance documents, which EC posted in January and February, cover certificates and voluntary certificate transfers and the application of unique device identification (UDI) rules specific to the device part of the medical product. MDCG guiding principles for issuing entities on the Basic UDI-DI [direct marking] requirements were posted last month.


The survey with MDCG members is now marked as finalized in the areas for which results would support future drafts of the identified implementing acts. These include those pertaining to expert panels, including fees, EU reference laboratories and expert laboratories and details around Eudamed. At the time of its October 2018 release, the rolling plan had marked the survey as ongoing through the relevant implementing acts. 

 

The consultation of MS and Cen/Cenetec on the scope of the standardization mandate is now complete.


The implementing act on common specifications for products without a medical purpose has been delayed. It was originally set for Q3 2018, then delayed to the beginning of 2019 and now to Q1 2020.


The rolling plan remains subject to quarterly reviews for updates throughout the MDR/IVDR transitions.

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