【奥译言】有关MDR/IVDR公告机构的最新消息:欧盟发布指定当局的最终评估表-奥咨达

【奥译言】有关MDR/IVDR公告机构的最新消息:欧盟发布指定当局的最终评估表

2019-10-21 10:53  阅读数:132 标签:

欧盟委员会医疗器械协调小组(MDCG)上周四(2019年10月17日)发布了一份最终评估表,供相关当局根据欧盟医疗器械法规(MDR)(2020年5月施行)和体外诊断医疗器械法规(IVDR)(2022年5月施行)指定符合性评估机构(CAB)和公告机构(NB)。


该表格中的空白处用于描述由指定当局进行的评估,并说明所有纠正和预防措施(CAPA)是否已得到适当处理并在必要时予以实施。


指定当局还可以列出有关组织要求和一般要求、质量管理体系要求、以及资源和过程要求等方面的不符合项及其对符合性评估机构和公告机构提出的整改措施以及纠正和预防措施(CAPA)的评估结果。


除了此次发布的这份表格,MDCG最近还发布了一系列指南文件,其中涉及基于MDR/IVDR的软件资格和分类、过渡性条款以及医疗器械专家小组指定等方面。


除了符合性问题外,能否在明年5月份之前根据MDR指定足够多公告机构的问题仍然存在。毕竟到目前为止,仅仅指定了5家公告机构。


Emergo咨询公司表示,目前根据医疗器械指令(MDD,93/42/EEC)指定的公告机构有56家,而据今年9月30日的MDCG利益相关者会议透露,这些公告机构中只有39家正在寻求MDR框架下的指定。


“这意味着其他17家公告机构的医疗器械CE标识认证的未来形势尚不明朗。在这17家公告机构中,有7家位于土耳其和瑞士。”目前尚不清楚欧盟与土耳其/瑞士之间的基于指令的当前协议是否会继续有效。


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.




来源:RAPS

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

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