MDR法规原文中英对照 第35~37条

Article 35 Authorities responsible for notified bodies

1. Any Member State that intends to designate a conformity assessment body as a  notified  body,  or  has  designated  a  notified body, to carry out conformity assessment activities under this Regu­lation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities  under national law and shall be  responsible  for setting up  and  carrying out  the necessary procedures for the assessment, designation and notifi­cation of conformity assessment bodies and for the monitoring of  notified bodies, including subcontractors and subsidiaries of those  bodies.

2. The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impar­tiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.

3. The authority responsible for notified bodies  shall be organised in  a manner such that each decision relating to designation  or notification  is taken by personnel different from those who carried out the  assessment.

4. The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.

5. The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies  with  other  Member  States,  the Commission and, when required, with other regulatory authorities.

6. The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.

Where the authority responsible for notified bodies is a  different  authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.

7. Member States shall make publicly available general information  on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks.

8. The authority responsible for notified bodies  shall  participate in the peer-review activities provided for in Article 48.

Article 36 Requirements relating to notified bodies

1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those  tasks.  In particular, notified bodies shall comply with Annex VII.

In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient adminis­trative,  technical  and  scientific  personnel  in   accordance   with Section 3.1.1 of Annex VII and personnel with  relevant  clinical expertise in accordance with Section 3.2.4 of Annex  VII,  where  possible employed by the notified body itself.

The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.

2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.

3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Article 37 Subsidiaries and subcontracting

1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcon­ tractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly.

2. Notified bodies shall take full responsibility for the tasks  performed on their behalf by subcontractors or subsidiaries.

3. Notified bodies shall make publicly available a list of their subsidiaries.

4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.

5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.

1，任何打算将合格评定机构指定为指定机构或已指定指定机构来进行本法规下的合格评定活动的会员国，应指定一个机构（``负责指定机构的机构''）根据国家法律可能由单独的组成实体组成，并且应负责建立和执行必要的程序，以进行合格评定机构的评估，指定和通知，并监督指定机构（包括这些机构的分包商和子公司）。

2.应建立，组织和运行负责指定机构的主管部门，以确保其活动的客观性和公正性，并避免与合格评定机构的利益冲突。

3.负责指定机构的主管机关的组织方式应使与指定或通知有关的每个决定均由与进行评估的人员不同的人员做出。

4.公告机构的主管机关不得进行公告机构在商业或竞争基础上进行的任何活动。

5，负责指定机构的主管部门应保护所获得信息的机密性。但是，它应与其他成员国，委员会以及在需要时与其他监管机构交换有关指定机构的信息。

6，负责公告机构的主管部门应有足够数量的主管人员永久可用，以适当地执行其任务。

负责公告机构的主管机关与国家医疗器械主管机关的主管机关不同的，应当确保就有关事项咨询国家医疗器械主管机关。

7.成员国应公开其管理合格评定机构的评估，指定和通知的措施以及指定机构的监督的一般信息，以及对此类任务有重大影响的变更。

8，负责指定机构的主管机关应参加第四十八条规定的同行评审活动。

1，指定机构应履行本法规指定的任务。他们应满足组织和一般要求以及完成这些任务所需的质量管理，资源和过程要求。公告机构尤其应遵守附件七。

为了满足第一小节中提到的要求，认证机构应根据附件VII第3.1.1节的要求，长期提供足够的行政，技术和科学人员，并具有根据3.2节的具有相关临床专业知识的人员。附件七第4条，在可能的情况下由指定机构本身采用。

附件七第3.2.3节和3.2.7节中提到的人员应由指定机构本身雇用，并且不得是外部专家或分包商。

2公告机构应提供所有相关文件，并应要求将包括制造商文件在内的所有相关文件提交给负责公告机构的主管部门，以使其能够进行评估，指定，通知，监视和监视活动，并促进评估中概述的评估本章。

3.为了确保统一适用附件七中规定的要求，委员会可通过执行法案，以解决分歧的解释和实际适用的问题。那些实施行为应按照第114条第3款规定的审查程序通过。

1，指定机构分包与合格评定有关的特定任务或向子公司寻求与合格评定有关的特定任务时，应核实分包拖拉机或子公司符合附件VII规定的适用要求，并应通知负责通知机构的机构。

2.公告机构应对分包商或子公司代表其执行的任务承担全部责任。

3.公告机构应公开提供其子公司的清单。

4.合格性评估活动可以由子公司分包或进行，前提是已相应地告知申请合格性评估的法人或自然人。

5，指定机构应将所有有关分包商或子公司资格验证及其根据本规章开展的工作的有关文件交由指定机构负责。