On 26 February,英国药品和保健品管理局(MHRA) published further guidance (这里可用)列出英国医疗器械的预期法规,英国是否应该在没有达成协议的情况下离开欧盟?(指导)本指南适用于“退出日”(预计晚上11点)。29 March 2019) subject to the (currently德赢真人视讯) Medical Devices (Amendment) (EU Exit) Regulations 2019 (英国MDR 2019)(这里可用) being passed by UK Parliament.This latest Guidance follows on from the MHRA's previous ‘no deal' scenario further guidance note in January regarding medicines,医疗器械与临床试验规程(这里可用).

  1. 立法背景

2002年医疗器械条例(英国MDR 2002) implement Directives 90/385/EEC,93/42/EEC and 98/79/EC on active implantable medical devices,medical devices,和in vitro诊断医疗器械(IVDs),respectively (欧盟指令) into UK law.  Pursuant to the European Union (Withdrawal) Act 2018,the UK MDR 2002 will continue to apply.

The 德赢真人视讯draft UK MDR 2019 will provide for any such changes to the UK MDR 2002,这对于英国退出欧盟是必要的,for example,they implement the Annexes to the EU Directives on conformity assessment procedures into national law (they were previously merely cross-referenced).  Further,the UK MDR 2019 will transpose the key elements of the Medical Device Regulation (EU) 2017/745 and thein vitro诊断医疗器械法规(欧盟)2017/746(EU Regulations) into the UK MDR 2002 (看到英国MDR 2019第2部分和第3部分)。这些新设备规则的应用时间表将与欧盟法规生效时间表一致,,2020年5月和2022年5月。

The EU Regulations provide for a number of changes to the device regime,including in relation to device classification,安全和性能,标签,临床证据要求,监管合规和设备警戒人员。他们还为设备的进口商和经销商引入新的义务。一旦采用英国MDR 2019,these changes will become part of UK law and will enter into force in 2020 and 2022.

The Guidance confirms that the MHRA will continue to perform market surveillance of medical devices on the UK market.  It then provides a general overview of the changes introduced by the UK MDR 2019,including those that stem from the implementation of the EU Regulations into national law post Brexit.  For the purposes of this blogpost we have focused on the key transitional changes that will apply on and around ‘exit day' but will continue to monitor any developments in this space and provide further updates in the future.

  1. 制造商

欧盟委员会已在其对利益相关者的通知中明确表示(这里可用) that in a "no deal" scenario,the EU-27 will no longer recognize UK-based authorised representatives,这在指南中提到。

英国MDR 2019将引入一项新的要求,即未在英国建立的制造商需要指定一名英国负责人代表其行事。制造商,or their UK Responsible Person,在将任何设备投放市场之前,必须向MHRA登记。英国负责人将通过提供指定函或签署的合同证明其身份,其中显示制造商和英国负责人的姓名和地址。文件必须确认英国负责人在海外制造商的同意下以及适用于英国市场设备的法规下行事。"  Moreover,someone at the UK Responsible Person must be "实际位置“在英国,必须是可联系的。英国负责人还将承担制造商关于设备警戒的报告义务。

  1. 设备注册要求

After 29 March 2019,all devices placed on the UK market must be registered with the MHRA.  The registering entity must have a "注册营业地“在英国,,必须是制造商或英国负责人。如果是后者,the Responsible Person will then assume the registration obligation.

The UK MDR 2019 introduce certain grace periods for this registration requirement,取决于设备的分类。

  • 注册前2019年7月29日:第三类医疗器械,Class IIB implantable medical devices,active implantable medical devices and IVD List A.
  • 注册前29 November 2019:IIB类非植入式医疗器械,IIA类医疗器械,体外诊断列表B和自测体外诊断。
  • 注册前2020年3月29日: Class I medical devices,general IVDs and Class A IVDs.

The MHRA will require the following registration information:

  • Device description in accordance with the Global Medical Devices Nomenclature (GMDN).这需要GMDN成员资格。
  • 三类器械:医疗器械名称,model,catalogue or reference number.

Companies should also refer to the common data elements as set out in the IMDRF Primary Medical Device Identity information (这里可用).

The registration,对注册的其他和/或后续更改都要收取100英镑的费用。已经注册的公司只需确认信息的准确性或提供更新,这可能会产生费用。此外,companies who are currently registered through an EU Authorised Representative must update the details to include a UK Responsible Person and the fee applies to this update as well.  Companies must renew their registration annually and pay a renewal fee of £100.

The MHRA will enter manufacturer information into the Public Access Database for Medical Device Registration (这里可用),which will list the company name,地址,mhra参考并列出已注册设备的类型。

  1. 合格评定和公告机构证书的状态

Manufacturers may continue to place devices on the UK market that have been CE marked pursuant to the EU Directives or EU Regulations.

MHRA明确表示,预计欧盟27国将在2019年3月29日后不再接受由英国通知机构颁发的证书,并且对于欧盟27国市场上的设备,制造商可能需要从欧盟27通知机构寻求重新认证。

Conversely,MHRA打算给予现有的英国通知机构(在欧盟制度下成立)持续的法律地位,to recognize the validity of certificates that they issued prior to 29 March 2019.  Thus,for devices placed on the UK market,the certificates issued by UK Notified Bodies will remain valid after exit day.  However,对于计划投放英国市场的新设备,要求在2019年3月29日之后进行合格评定,制造商只能依赖欧盟27号公告机构颁发的公告机构证书,在成功完成合格评定之后。

  1. Clinical Investigations and Performance Evaluations

The UK will continue to accept existing clinical investigations approvals,所以不需要重新提交申请。