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BSI将正式受理MDR申请
来源:http://www.microkn.com/content/45.html    作者:微珂    发布时间:2019-05-22    146次浏览

 BSI最近已宣布,经英国药品和健康产品管理局(MHRA)批准授权,BSI已成为全球首家获得欧盟医疗器械法规(MDR)(EU 2017/745)发证资质的欧盟公告机构。

2019年6月3日起,BSI正式受理MDR申请


BSI(英国公告机构,NB 0086)将从2019年6月3日起,正式受理MDR申请。BSI计划在未来几个月安排报价等工作,预计将于2020年1月开始进行交付。无论您的MDD证书是由BSI英国公告机构(NB 0086)或BSI荷兰公告机构(NB 2797)签发,BSI现在均可以为客户提供全范围的MDR审核。如需进一步了解BSI授权范围,请访问欧盟NANDO网站进行查询。对于因需要外部咨询(consultations)、未发布通用规范,以及目前未在监管体系内有被公认的专业知识而导致的申请进度延迟,均不在BSI的控制范围内。

请注意,BSI目前仍将优先处理MDD指令的相关申请,包括变更、续证、扩证等。此优先级安排可确保BSI客户的产品在欧盟上市,同时满足MDR规定的过渡时间表。

We would now like to inform you that we are accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019. BSI will begin to process quote requests and look to schedule the work over the coming months, with the delivery of work expected to commence in January 2020. BSI will now be able to provide conformity assessments to the full scope of the MDR, for BSI Directive clients under either our UK or Netherlands Notified Bodies. For further details on BSI’s scope, please visit the NANDO information system. Applications which rely on external consultations, unpublished common specifications or expertise which is not currently available within the regulatory system will experience an additional delay to the application process, unfortunately, this is out of BSI control.

Please be aware that our current priority remains those all current applications and work under the Directives; this includes changes, renewals, extension to scope etc. This priority is to ensure that our clients maintain market access and meet the transition timelines stated in the MDR.

英国脱欧和MDR:
我们了解客户对英国脱欧和BSI英国公告机构MDR发证资质的担忧。BSI想与您分享我们目前的理解:英国目前政治形势表明,英国将与欧盟达成一项协议,并有实施过渡期。在这种情况下,BSI 英国公告机构在过渡期(目前相关文件显示为2020年12月底)结束前仍是欧盟公告机构。因此,我们计划启动BSI英国公告机构(NB 0086)下的MDR的认证工作。

欧盟法规允许自愿更改公告机构。根据MDR法规第58 条款,以及 IVDR法规第53条款,当BSI荷兰公告机构(NB 2797)获得MDR认证资质后,英国公告机构(NB 0086)下的申请可变更至荷兰公告机构(NB 2797)。具体变更流程BSI也将在适当的时候公布。欧盟MDCG 2018-8指导文件指出:在自愿进行证书转移的情况下,即将退出欧盟的公告机构所进行的符合性审核的活动,可由新加入欧盟的公告机构继续受理。BSI认为,如果将MDR申请从NB 0086迁移至NB 2797,也可以适用这些原则。

BSI对英国和荷兰之间的证书转移方法充满信心。但是,仍有一些与时间相关的低风险因素不受BSI掌控。
NB 2797可能无法在2020年5月之前完成一些正在申请过程中的客户迁移。对于该情况的解决方案是: NB 0086先完成MDR的申请工作,在NB 2797获得资质后再进行迁移。
其他未包含在上述所列的不可预见的情况

请注意:如何选择将由贵公司根据您自身的情况决定


We are aware of concerns around Brexit and MDR applications into a UK notified body, we would like to share our current understanding. The situation in UK politics denotes that a deal should be agreed, and the transition period implemented. In this situation, BSI UK would remain an EU Notified Body until the end of the transition, currently documented as the end of December 2020. Therefore, we plan to initiate MDR work under the Notified Body 0086.

The EU Regulations allow for a voluntary change of Notified Body. Applications lodged with NB 0086 will be able to change to Netherlands NB 2797 following Article 58 MDR/53 IVDR when the BSI NL notified body is designated. Full details of the process will be published in due course of time. The guidance document MDCG 2018-8 states that an incoming Notified Body can take into account the conformity assessment activities conducted by the outgoing Notified Body in the context of voluntary certificate transfers. BSI believes that these principles can also be applied if and when an application is moved from NB 0086 to NB 2797.

BSI has a high level of confidence in our approach. However, there is a small risk relating to timing that we cannot fully control.
NB 2797 may not be designated in time to complete an in-application move to NB 2797 prior to May 2020. Our contingency plan in this scenario will be to complete MDR applications in NB 0086 and move to NB 2797 later once we have achieved designation.
Other unforeseen developments that may not allow the above process.

Please NOTE: it is your commercial decision for how you wish to proceed.

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