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MHRA发布英国无协议脱欧指南
来源: | 作者:SUNGOGROUP | 发布时间: 23天前 | 111 次浏览 | 分享到:
在2019年1月3日,MHRA发布了关于无协议脱欧发生时的医疗器械市场准入的指导方针。 指导方针的要点摘要如下:
•  MHRA将承担英国市场的管理责任;
•  CE标志在英国仍然有效,预计目前不需更改标签;
•  MDR和IVDR将在英国与欧盟同时实施;
•  非英国制造商在英国市场上放置设备需要指定一名英国代表,其角色类似于欧洲授权代表;
•  英国制造商或英国负责人必须在英国注册该设备。
On January 3rd, 2019, the MHRA published guidelines for the situation of a no-deal Brexit. SUMMARY OF KEY POINTS of the guideline:
• MHRA will take on responsibility for the UK market;
• The CE Mark remains valid in the UK and no label changes are foreseen for now;
• MDR and IVDR will be implemented in the UK in parallel with the EU
• Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
• The UK-based manufacturer or the UK Responsible Person must register the device in the UK.

位于英国境外的制造商,无论是欧盟制造商还是非欧盟制造商,都必须指定一位必须位于英国的英国责任人(UK REP)。英国REP的作用和任务与欧盟授权代表欧盟REP的相似。现在不需要在设备标签上标明英国REP。英国制造商或其英国REP必须在MHRA注册他们的设备。Manufacturers based outside the UK, whether EU-based or non-EU-based, must appoint a UK Responsible Person (UK REP) that must be based in the UK. The role and tasks of the UK REP are similar to those of the European Authorized Representative, the EU REP. It is for now not required to indicate a UK REP on a device label. UK-based manufacturers, or their UK REPs, must register their devices with MHRA. 

此注册有时间要求:
•  对于III类设备,IIb类植入设备,有源植入设备和IVD List A设备,脱欧后四个月内;
•  对于Class IIb非植入设备,Class II设备,IVD List B设备和自测IVD,脱欧后八个月内;
•  所有其他设备(I类和自我认证的IVD),在英国脱欧后12个月内。
There are timelines for this registration:
• Within four months after Brexit for Class III devices, Class llb implantable devices, active implantable devices and IVD List A devices;
• Within eight months after Brexit for Class llb non-implantable devices, Class lla devices, IVD List B devices and Self-test IVDs;
• Within 12 months after Brexit for all other devices (Class I and self-certified IVDs).

中国企业的应对措施建议:
• 对于原有欧盟授权代表在英国境内的应尽快变更成欧盟其余成员国境内的欧盟授权代表。SUNGO德国公司和荷兰公司均可以提供欧盟授权代表服务,欢迎垂询。
• 对于产品出口到英国的医疗器械制造商,应单独指定区别于欧盟授权代表的英国代表并按照MHRA规定的时间要求完成英国的器械注册。SUNGO英国公司可以提供英国代表和英国器械注册服务,欢迎垂询。

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