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欧盟委员会更新了MDR/IVDR实施的工作计划
来源: | 作者:SUNGOGROUP | 发布时间: 104天前 | 231 次浏览 | 分享到:

欧盟委员会(EC)对欧盟医疗器械法规(REGULATION (EU) 2017/745,简称“MDR”)和欧盟体外诊断医疗器械法规(REGULATION (EU) 2017/746,简称“IVDR”)的滚动实施计划进行了更新,并交代了部分举措所取得的进展。  


该滚动计划对1月份发布的概况介绍进行了说明。这些概况介绍的目标受众包括:授权代表、进口商、分销商、非欧盟/欧洲经济区(EEA)国家主管当局以及医疗器械和体外诊断采购生态系统(包括医院和诊所)的相关人员。这些可交付成果是该计划宣传活动的一部分,旨在避免“瓶颈”出现,并确保医疗器械的可及性。


除了一系列新的概况介绍外,欧盟委员会上个月还发布了信息图表和2020/2022年过渡时间表,以便帮助相关企业机构为应对新增的监管要求做准备。

 

医疗器械协调小组(MDCG)于2017年成立,旨在为MDR/IVDR滚动计划中概述和定期更新的基本执行行为(实施细则)和措施提供方向指引。该小组也发布了一系列新的指南文件。欧盟委员会于最近两个月(即1月和2月)发布的两份指南文件包含证书和证书自愿转让情况,以及医疗器械的唯一器械标识(UDI)规则的应用情况。上个月,MDCG针对签发实体发布了关于基本UDI-DI[直接标记]要求的指南文件。


在那些未来需要用调查结果来支持执行行为草案的领域,医疗器械协调小组(MDCG)成员的调查目前已进入“完结”状态,这包括与专家小组有关的事宜,包括费用、欧盟基准实验室和专家实验室以及与欧洲医疗器械数据库(Eudamed)相关的详细信息。欧盟在2018年10月发布MDR/IVDR实施的工作计划之际,上述调查还处于“进行中”的状态。


MS和Cen/Cenetec关于标准化授权范围的讨论协商现已完成。


关于无医疗用途产品通用规范的执行行为现已推迟施行。该执行行为原定于2018年第三季度施行,随后推迟到2019年初,现又推迟到2020年第一季度。

滚动计划将在MDR/IVDR过渡期间每季度进行一次更新审查。


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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