Article 10  General obligations of manufacturers

1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

2. Manufacturers shall establish, document, implement and  maintain  a system for risk management as described in Section 3 of Annex I.

3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex  XIV, including     a PMCF.

4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date  technical  documentation  for  those  devices. The technical documentation shall be such as to allow the conformity of the  device with  the requirements of this Regulation  to   be assessed. The technical documentation shall include the elements set out in Annexes II and III.

The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the  Annexes II and III.

5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.

6. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.

7. Manufacturers shall comply with the obligations relating to  the UDI system referred to in Article 27 and with the registration obli­ gations referred to in Articles 29 and 31.

8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with  Article 56,  available for the  competent  authorities for a period of  at  least  10  years  after  the  last  device  covered  by  the  EU declaration of conformity has been placed on  the  market.  In  the case of implantable devices, the period  shall be  at least 15  years after the last device has been placed on the market.

Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that  technical  documentation  in  its  entirety or a summary thereof.

A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.

9. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regu­ lation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this  Regulation  in  the  most  effective manner  and  in a manner that is proportionate to the risk class and the type of device.

The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

The quality management system shall address at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(b) identification of applicable general safety and performance requirements and exploration of options to address those require­ ments;

(c) responsibility of the management;

(d) resource management, including selection and control of suppliers and sub-contractors;

(e) risk management as set out in in Section 3 of Annex I;

(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;

(g) product realisation, including planning, design, development, production and service provision;

(h) verification of the UDI assignments made in accordance with  Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;

(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;

(j) handling communication with competent authorities, notified  bodies, other economic operators, customers and/or other stake­ holders;

(k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

(l) management of corrective and preventive actions  and  verification of their effectiveness;

(m) processes for monitoring and measurement of output, data analysis and product improvement.

10. Manufacturers of devices shall implement and keep  up  to date  the post-market surveillance system in accordance with Article 83.

11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the  device  is made available to the user or  patient.  The  particulars  on  the  label  shall be indelible, easily legible and clearly comprehensible to the intended user or patient.

12. Manufacturers who consider or have reason to believe that a device which they have placed on  the  market  or  put  into  service  is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the auth­ orised representative and importers accordingly.

Where the device presents a serious risk, manufacturers shall immedi­ ately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.

13. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.

14. Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device,  in  an  official  Union  language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that  is  impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.

If the manufacturer fails to cooperate or the information and documen­ tation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the  device  from  that market or to recall it until the manufacturer cooperates or provides complete and correct information.

If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph  to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or  user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.

The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and docu­ mentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.

15. Where manufacturers have their devices designed or manu­ factured by another legal or natural person the information on  the  identity of that person shall  be  part  of  the  information  to  be  submitted in accordance with Article 29(4).

16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.

Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

1.制造商将其设备投放市场或投入使用时，应确保其设计和制造符合本法规的要求。

2，制造商应建立，记录，实施和维护附件一第3节所述的风险管理体系。

3，制造商应按照第61条和附件XIV规定的要求进行临床评估，包括PMCF。

4，除定制设备外的设备制造商应草拟并更新这些设备的技术文档。技术文件应允许评估设备是否符合本法规的要求。技术文件应包括附件二和附件三所列要素。

委员会有权根据技术进步对附件二和附件三进行修订的第115条通过授权法。

5，定制设备的制造商应根据附件XIII的第2节起草，更新并向主管当局提供文件。

6，在按照适用的合格评定程序证明符合适用要求的地方，除定制或研究用的设备外，其他设备的制造商应根据第19条起草欧盟合格声明，并贴上CE标志符合第20条的规定。

7，制造商应遵守与第27条所述的UDI系统有关的义务以及第29条和第31条所述的注册义务。

8，制造商应将根据第56条签发的技术文件，欧盟符合性声明以及任何相关证书的副本（包括任何修正和补充）（如适用）至少在有效期内供主管当局使用欧盟符合性声明中涵盖的最后一种设备投放市场已有10年。对于可植入设备，该期限应为最后一个设备投放市场后至少15年。

根据主管当局的要求，制造商应按照其中的指示提供完整的技术文件或其摘要。

为了在授权联盟的代表完成第11条第3款中提到的任务的情况下，在联盟以外设有注册营业地点的制造商应确保授权代表具有永久可用的必要文件。

9，制造商应确保制定程序以保持批量生产符合本法规的要求。应及时充分考虑宣布设备合格性所依据的设备设计或特性更改以及协调标准或CS的更改。除研究设备外，设备制造商应建立，形成文件，实施，维护，保持最新并不断改进质量管理体系，以确保以最有效的方式并与之成比例地确保符合本法规的要求。风险等级和设备类型。

质量管理体系应涵盖制造商组织处理过程，程序和设备质量的所有部分和要素。它应支配实施为实现本规章的规定所必需的原则和行动所需的结构，职责，程序，过程和管理资源。

质量管理体系应至少解决以下几个方面：

（a）法规遵从性策略，包括符合性评定程序和系统所涵盖设备的修改管理程序；

（b）确定适用的一般安全和性能要求，并探讨解决这些要求的方案；

（c）管理层的责任；

（d）资源管理，包括选择和控制供应商和分包商；

（e）附件一第3节规定的风险管理；

（f）根据第61条和附件XIV，包括PMCF进行临床评估；

（g）产品实现，包括计划，设计，开发，生产和服务提供；

（h）验证根据第27条第3款对所有相关设备进行的UDI分配，并确保根据第29条提供的信息的一致性和有效性；

（i）根据第83条建立，实施和维护售后监督系统；

（j）处理与主管当局，指定机构，其他经济经营者，客户和/或其他利益相关者的沟通；

（k）在警惕的情况下报告严重事件和现场安全纠正措施的过程；

（l）管理纠正和预防措施并验证其有效性；

（m）监视和测量输出，数据分析和产品改进的过程。

10，设备制造商应根据第83条的规定实施并保持最新的售后监控系统。

11，制造商应确保设备随附附件I第23节中规定的信息，并以提供用户或患者使用该设备的成员国确定的官方联合语言（一种或多种）为准。标签上的细节对于预定的使用者或患者而言应是不可磨灭的，易于辨认的并且应清楚地理解。

12，制造商认为或有理由相信其投放市场或投入使用的设备不符合本法规的规定，应立即采取必要的纠正措施以使该设备符合要求，将其撤回或视情况记得。他们应将有关设备的分销商以及相应的授权代表和进口商（如适用）告知经销商。

如果设备存在严重风险，制造商应立即通知提供设备的会员国主管当局，并在适用的情况下，根据第56条通知为设备签发证书的指定机构，不遵守规定以及采取的任何纠正措施。

13，制造商应具有第87条和第88条所述的事件记录和报告以及现场安全纠正措施的系统。

14，制造商应应主管当局的要求，以有关成员国确定的官方正式语言，向其提供证明设备合格的所有必要信息和文件。制造商在其注册营业地所在成员国的主管当局可能会要求制造商免费提供该设备的样品，或者在不可行的情况下准予使用该设备。制造商应在其要求下与主管当局合作，采取任何纠正措施以消除或（如果不可能）减轻其投放市场或投入使用的设备所带来的风险。

如果制造商未能合作，或者提供的信息和文档不完整或不正确，主管当局可以采取一切适当措施，禁止或限制设备的使用，以确保公共卫生和患者安全。在其国内市场上撤回该设备或召回该设备，直到制造商合作或提供完整正确的信息为止。

如果主管当局认为或有理由相信设备造成了损坏，则应应要求，协助向可能受到伤害的患者或使用者以及适当的情况下，将第一小节中提及的信息和文件提供给患者。患者或用户的所有权的继任者，患者或用户的健康保险公司或其他受患者或用户造成的损害影响的第三方，而不会影响数据保护规则，并且除非有公开的最高公众利益，并且不影响保护知识产权。

主管当局不必遵守第三小节中规定的义务，因为通常在诉讼程序中处理第一小节中提到的信息和文件的披露。

15，如果制造商的设备是由另一位法人或自然人设计或制造的，则该人的身份信息应作为根据第29条第4款提交的信息的一部分。

16.自然人或法人可以根据适用的联盟和国家法律要求赔偿由有缺陷的设备造成的损坏。

制造商应以与风险等级，设备类型和企业规模相称的方式，采取措施为他们根据第85/374 / EEC号指令的潜在责任提供足够的财务保障，而又不影响根据国家法律采取更多保护措施。