MDR法规原文中英对照

Article 11 Authorised representative

1. Where the manufacturer of a device is not established  in  a  Member State, the device may only be placed on  the Union  market if  the manufacturer designates a sole authorised representative.

2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the auth­ orised representative and shall be effective at least for all devices of the same generic device group.

3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

The mandate shall require, and the manufacturer shall enable, the auth­ orised representative to perform at least the following tasks in relation to the devices that it covers:

(a) verify that the EU declaration of conformity and technical docu­ mentation have been drawn up and, where applicable, that an appro­ priate conformity assessment procedure has been carried out by the manufacturer;

(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if  applicable,  a  copy  of  the  relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);

(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obli­ gations laid down in Articles 27 and 29;

(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate  the  conformity  of  a  device,  in  an official Union language determined by the Member State concerned;

(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for  samples,  or  access  to  a  device  and verify that the competent authority receives the samples or is given access to the device;

(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible,  mitigate the risks posed by devices;

(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(h) terminate the mandate if the manufacturer acts contrary to its obli­ gations under this Regulation.

4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).

5. Without prejudice to paragraph 4 of this Article, where the manu­ facturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative  shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

6. An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of  the  termination  of  the  mandate and the reasons therefor.

7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to  the  competent  authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.

Article 12 Change of authorised representative

The detailed arrangements for a change of authorised  representative  shall be clearly defined in an agreement between the manufacturer,  where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address  at  least the following aspects:

(a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;

(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

(c) the transfer of documents, including confidentiality aspects and property rights;

(d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming auth­ orised representative any complaints or reports from healthcare professionals, patients or users about  suspected  incidents related to  a device for which it had been designated as authorised represen­ tative.

1.如果设备制造商未在成员国内建立，则只有在制造商指定唯一授权代表的情况下，该设备才能在联盟市场上投放。

2.该名称应构成授权代表的授权，该名称仅在经授权代表书面接受后才有效，并且至少对同一通用设备组中的所有设备都有效。

3.授权代表应执行其与制造商之间约定的任务中指定的任务。授权代表应要求将任务授权副本提供给主管当局。

该授权书应要求授权的代表，并且制造商应使授权代表能够对其所涵盖的设备至少执行以下任务：

（a）验证是否已经制定了欧盟符合性声明和技术文档，并且在适用的情况下，验证了制造商是否进行了适当的符合性评估程序；

（b）保留根据第56条签发的技术文件副本，欧盟符合性声明以及（如果适用）相关证书的副本，包括任何修正和补充，以供主管当局处置。第10条第8款所指的期限；

（c）遵守第31条规定的注册义务，并验证制造商是否遵守了第27条和第29条规定的注册义务；

（d）应主管当局的要求，以有关会员国确定的正式联盟语言向主管当局提供证明设备合格的所有必要信息和文件；

（e）将授权代表在其注册营业地的成员国的主管当局提出的任何样品的请求或制造商的使用权转给制造商，并核实该主管当局已收到样品或有权访问装置;

（f）与主管当局合作采取任何预防或纠正措施，以消除或（如果不可能的话）减轻设备带来的风险；

（g）立即告知制造商有关医疗保健专业人员，患者和用户的投诉和报告，这些投诉和报告涉及与指定医疗器械有关的可疑事件；

（h）如果制造商的行为违反了本法规规定的义务，则终止任务。

4，本条第3款所指的任务授权不应委托制造商承担第10（1），（2），（3），（4），（6），（7），（9）条规定的义务，（10），（11）和（12）。

5，在不损害本条第4款规定的情况下，制造商不是在成员国中建立的，并且未遵守第10条规定的义务，授权代表应对与有缺陷的设备依法承担法律责任，并与制造商共同或分别地。

6，以第3款（h）项所指为由终止授权的授权代表应立即通知其成立所在成员国的主管当局，并酌情通知参与该授权的指定机构。终止任务的设备的合格评定及其原因。

7，本法规中对制造商在其注册营业地所在成员国的主管当局的提述应理解为对制造商指定的授权代表所代表的成员国的主管当局的提述在第1款中有其注册营业地。

更换授权代表的详细安排应在制造商（在可行的情况下）之间的协议中明确规定，离任授权代表与新任授权代表之间应达成协议。该协议应至少涉及以下方面：

（a）离任授权代表的任期终止日期和离任授权代表的任期开始日期；

（b）制造商提供的信息（包括促销材料）中指明离任的授权代表的日期；

（c）文件的转让，包括机密性和财产权；

（d）任务授权结束后离任的授权代表有义务将医疗保健专业人员，患者或用户对与指定设备有关的可疑事件的任何投诉或报告转发给制造商或新进授权的代表作为授权代表。