【奧譯言】有關MDR/IVDR公告機構的最新消息:歐盟發布指定當局的最終評估表

2019-10-21 10:53 ?閱讀數:222 標簽:

歐盟委員會醫療器械協調小組(MDCG)上周四(2019年10月17日)發布了一份最終評估表,供相關當局根據歐盟醫療器械法規(MDR)(2020年5月施行)和體外診斷醫療器械法規(IVDR)(2022年5月施行)指定符合性評估機構(CAB)和公告機構(NB)。


該表格中的空白處用于描述由指定當局進行的評估,并說明所有糾正和預防措施(CAPA)是否已得到適當處理并在必要時予以實施。


指定當局還可以列出有關組織要求和一般要求、質量管理體系要求、以及資源和過程要求等方面的不符合項及其對符合性評估機構和公告機構提出的整改措施以及糾正和預防措施(CAPA)的評估結果。


除了此次發布的這份表格,MDCG最近還發布了一系列指南文件,其中涉及基于MDR/IVDR的軟件資格和分類、過渡性條款以及醫療器械專家小組指定等方面。


除了符合性問題外,能否在明年5月份之前根據MDR指定足夠多公告機構的問題仍然存在。畢竟到目前為止,僅僅指定了5家公告機構。


Emergo咨詢公司表示,目前根據醫療器械指令(MDD,93/42/EEC)指定的公告機構有56家,而據今年9月30日的MDCG利益相關者會議透露,這些公告機構中只有39家正在尋求MDR框架下的指定。


“這意味著其他17家公告機構的醫療器械CE標識認證的未來形勢尚不明朗。在這17家公告機構中,有7家位于土耳其和瑞士。”目前尚不清楚歐盟與土耳其/瑞士之間的基于指令的當前協議是否會繼續有效。


英文原文

EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR


The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022.


The form includes space to describe the assessment carried out by the designating authority and whether all corrective and preventive actions (CAPAs) have been appropriately addressed and, where required, implemented.


Designating authorities can also list non-conformities and their assessments of the corrections and CAPAs proposed by the CAB/NB related to organizational and general requirements, quality management system requirements, and resource and process requirements.


The release of the form is part of a flurry of recent guidance documents from the MDCG, including guidance on the qualification and classification of software under MDR and IVDR, transitional provisions and designating expert device panels.


In addition to questions on compliance, questions still linger on whether there will be enough NBs designated under MDR by next May. Just five NBs have been designated so far.


According to the consulting group Emergo, currently there are 56 NBs designated for the Medical Devices Directive, while at the MDCG stakeholders meeting of 30 September, only 39 of these current NBs are also seeking designation under MDR.


“That means that the future CE Mark certifications for medical devices of 17 Notified Bodies is unclear. Seven of these entities are based in Turkey and Switzerland,” and it’s unclear if the current agreements between the EU and Turkey and Switzerland regarding the directives will remain in place.




來源:RAPS

原文鏈接:https://www.raps.org/news-and-articles/news-articles/2019/10/ec-unveils-designating-authoritys-final-assessmen

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