欧盟委员会最新数据显示：近一半在欧盟批准的医疗器械产品，是由英国公告机构进行认证的。BSI作为欧盟领先的高风险医疗器械公告机构，已制定全面的保障方案，以确保我们全球的客户可继续将BSI作为欧盟公告机构。
BSI已获得荷兰认可委员会授权的ISO 13485认证资质；预计将于2018年7月或8月获得MDD、AIMDD、IVDD认证资质。
英国脱欧：现状和时间表
欧盟27国与英国未来关系的谈判预计于2018年秋季达成一致。英国计划于2019年3月29日退出欧盟，届时所有欧盟法律（包括MDD，AIMDD和IVDD）仍将继续适用于英国。法律过渡截止日期拟定为2020年12月31日，在过渡期内，英国仍将执行欧盟法律。
英国与欧盟就互认协议（MRA）在积极磋商中，如达成一致，2020年之后欧盟法律仍将继续适用于英国。
和欧盟其它一些法规一样，MDR和IVDR目前尚未被完全实施，故此只能将部分法规要求纳入英国的法律范围。因此我们希望英国与欧盟尽早达成一致以消除这个问题。我们将持续为您更新最新进展。
BSI将拥有两家公告机构
BSI位于阿姆斯特丹办公室的认证资质已取得重大进展。
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BSI已正式向荷兰主管当局（IGJ）申请覆盖包括AIMD（90/385/EEC）有源植入医疗器械指令，MDD （93/42/EEC）医疗器械指令，以及IVDD （98/79/EC）体外诊断医疗器械指令的授权。IGJ已经完成对我们的正式审核，所有的授权的过程按照计划进行，BSI预计将于2018年7月或8月获得认证资质。关于MDR和IVDR的认证资质，BSI目前处于第一批申请的行列中。
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BSI现已获得荷兰认可委员会（RVA）授权的ISO 13485认证资质。这是我们为英国脱欧制定的保障方案的一大进步。RVA是根据ISO/IEC 17021对管理体系认证机构进行认可的。
BSI目前正与IGJ和MHRA进行协商，以确保两个公告机构的工作有效开展。如客户有要求，我们将为客户进行证书的转证。证书的转证仅涉及行政程序，客户几乎不会受影响。
为保证患者安全，我们将在BSI两个公告机构之间共享信息，并对证书保持完整的可追溯性和关联。产品标签将需要更新。但是，我们预计由于有完整的追溯，公告机构的转证短期内不需要更新标签，您可以将标签的更新和您新老产品更新上市或者新法规MDR和IVDR的转版的标签更新一起进行。
企业就英国脱欧做好准备
BSI一直与所有相关英国政府部门（如：药品及健康产品管理部门MHRA）保持密切联系，以确保他们了解脱欧不仅会影响英国的公告机构，更重要的是也会影响我们的客户和广大使用这些医疗器械的患者。
我们建议您开始考虑企业的预期变化，并制定相应计划，尤其是关于供应链的控制。我们将在后续BSI免费的网络研讨会中具体讲解。
BSI最新网络研讨会：
英国脱欧对法规监管有何影响？2018年5月23日（星期三 ）22:30-23:30点击报名
BSI全球医疗器械高级副总裁Gary Slack将重点讲述：
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英国脱欧进展
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脱欧对MDR和IVDR的影响
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BSI应对脱欧的计划及保障方案
* 若中英版存在任何冲突、歧义或矛盾，概以英文版为准。
As you are aware Brexit is posing many questions and uncertainties in our sector so we would like to update you on the latest information we have regarding Brexit and your Medical Device Notified Body.
EU Commission data indicates that approaching half of all medical device products certified in the EU use UK Notified Bodies; BSI is Europe’s leading Notified Body for high-risk medical devices. We have a strong contingency plan in place to ensure that you, our global clients, can continue to use BSI as your European Notified Body but we also wanted to provide you with some wider information to support this substantial change.
BSI has now achieved Accreditation for ISO 13485 under the Dutch Accreditation Council (RVA); this is a major advancement in our preparations for Brexit contingency plans.
Brexit: Current status and timelines
As we move through 2018 and the negotiations continue around the future relationship between the EU 27 countries and the UK; it is anticipated that an agreement will be reached in autumn 2018. The UK is scheduled to leave the EU on 29 March 2019, at which point all EU law will remain applicable to the UK, including the full requirements of the MDD, AIMDD and IVDD. The laws will maintain alignment with EU law during the transition period, currently proposed until 31 December 2020.
It is assumed a Mutual Recognition Agreement (MRA) will be agreed which will maintain these laws following 2020.
The MDR and IVDR will not be fully applicable at this point, so only the limited applicable provisions of the regulations will be copied into UK law. The concern will be the same for many pieces of EU law, and as such we expect an agreement to eliminate this issue. We will continue to provide you with further updates on this, as and when facts appear.
One BSI, Two Notified Bodies
We are making significant progress regarding our applications for completing our business out of our already active Amsterdam office.
- BSI has formally applied for designation as a Medical Device Notified Body in the Netherlands under the EU Directives - (90/385/EEC) Active implantable medical devices, (93/42/EEC) Medical devices and (98/79/EC) IVD directive - within the oversight of the Dutch Health and Youth Care Inspectorate (IGJ). IGJ has completed our initial audit, and we are working through the process of designation, with a target of designation in July/August 2018. Our application for the MDR and IVDR is currently in the first wave of applications for these new Regulations.
- BSI has now achieved ISO 13485 Accreditation under the Dutch Accreditation Council (RVA); this is a major advance in our preparations for our Brexit contingency plans: the RVA accredits management system certification bodies based on the ISO/IEC 17021 standard.
BSI is currently in talks with both IGJ and MHRA to ensure pragmatic processes for working across the two Notified Bodies and how we will manage any migration of certificates and clients, should this be a requirement. It is understood that any movement of certificates will be a purely administrative process, with limited impact on our clients.
As we will be sharing the information between two BSI subsidiaries and be able to maintain full traceability and linkages to the current certificates, we can ensure continued patient safety. Product labelling will need to be updated. However, we anticipate that due to continued traceability, the short timelines usually associated with a NB transfer will not be upheld and should allow you to transfer the labelling over during your normal product lifecycle plans, as new products are introduced or during the change to the new Regulation.
Planning for Brexit in your business
BSI continues to work closely with all relevant UK government departments including the Medicines & Healthcare products Regulatory Authority to ensure they understand the implications not only for UK Notified Bodies, but more importantly for our clients and patients who use these products.
However, there are aspects of the anticipated changes which we recommend you should start to consider and plan within your business, specifically around control of your supply chain. We will cover this subject in more detail during the free BSI webinar.
We would like to invite you to join us for a Live Webinar: ‘What are the regulatory implications of Brexit?’
Join Gary Slack, Senior Vice President Global Medical Devices, for a 50-minute webinar.
The webinar will review the status and implication of Brexit and how these will impact the implementation of both the MDR and IVDR. Gary will outline BSI’s plans and the contingencies we have in place to deal with the uncertainty caused by the UK withdrawal from the EU.
Date: 23 May 2018, at 15:30 BST.
Register here, if you cannot attend we will send a link to you which will allow you to listen back.
Where can I find more information?
BSI will continue to keep you updated as the negotiations progress. For now, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives. Please check our Brexit web page for the latest information available and ongoing updates. If you have any questions or concerns, please contact your normal BSI contact at any time.
