Article 10
General obligations of manufacturers工廠責任
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.製造商將其設備投放市場或投入使用時，應確保其設計和製造符合本法規的要求。
2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.製造商應建立，記錄，實施和維護Annex一第3節中所述的風險管理系統。
3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.製造商應按照第61條和AnnexXIV規定的要求進行臨床評估，包括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.除定制設備外的設備製造商應草擬並更新這些設備的技術文檔。技術文件應允許評估設備是否符合本法規的要求。技術文件應包括Annex二和Annex三所列要素。
委員會有權根據技術進步對Annex二和Annex三進行修訂的第115條通過授權法。
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.定制設備的製造商應按照AnnexXIII的第2節規定起草，更新並向主管當局提供文件。
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.
如果按照適用的合格評定程序證明符合適用要求，則除定製或研究用的設備外，設備製造商應根據第19條起草歐盟合格聲明，並貼上CE標誌符合第20條的規定。
7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.製造商應遵守第27條提及的與UDI系統有關的義務以及第29和31條提及的註冊義務。
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.
製造商應將技術文件，歐盟符合性聲明以及根據第56條簽發的任何相關證書（包括任何修正和補充）的副本（如果適用）的有效期限至少為主管當局使用歐盟符合性聲明中涵蓋的最後一種設備投放市場已有10年。對於可植入設備，該期限應為最後一個設備投放市場後至少15年。
根據主管當局的要求，製造商應按照其中的指示提供完整的技術文件或其摘要。
為了在授權聯盟的代表完成第11條第3款所述的任務的情況下，在聯盟以外設有註冊營業地點的製造商應確保授權代表具有永久可用的必要文件。
9. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. 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:
製造商應確保制定程序以保持批量生產符合本法規的要求。應及時充分考慮設備設計或特性的變化，以及宣佈設備合格性所依據的協調標准或CS的變化。除研究設備外，設備的製造商應建立，形成文件，實施，維護，保持最新並不斷改進質量管理體系，以確保以最有效的方式並與之成比例地確保符合本法規的要求。風險等級和設備類型。
質量管理體系應涵蓋製造商組織處理過程，程序和設備質量的所有部分和要素。它應支配實施為實現本規章的規定所必需的原則和行動所需的結構，職責，程序，過程和管理資源。
| (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;監管合規性策略，包括合規性評估程序和系統所涵蓋設備的修改管理程序； |
(b) |
identification of applicable general safety and performance requirements and exploration of options to address those requirements;確定適用的一般安全和性能要求，並探索解決這些要求的方案； |
(c) |
responsibility of the management;管理層的責任； |
(d) |
resource management, including selection and control of suppliers and sub-contractors;資源管理，包括選擇和控制供應商和分包商； |
(e) |
risk management as set out in in Section 3 of Annex I;Annex一第3節中規定的風險管理； |
(f) |
clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;根據第61條和AnnexXIV進行臨床評估，包括PMCF； |
(g) |
product realisation, including planning, design, development, production and service provision;產品實現，包括計劃，設計，開發，生產和服務提供； |
(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;驗證根據 Article 27(3)條第3款對所有相關設備進行的UDI安排，並確保根據Article 29條提供的信息的一致性和有效性； |
(i) |
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;根據第83條的規定，建立，實施和維護售後監控系統； |
(j) |
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;處理與主管部門，指定機構，其他經濟運營商，客戶和/或其他利益相關者的溝通； |
(k) |
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;在警惕的情況下報告嚴重事件和現場安全糾正措施的過程； |
(l) |
management of corrective and preventive actions and verification of their effectiveness;管理糾正和預防措施並驗證其有效性； |
(m) |
processes for monitoring and measurement of output, data analysis and product improvement.監視和測量輸出，數據分析和產品改進的過程。 |
10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.器械製造商應根據第83條的規定，實施並保持最新的售後監督制度。
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.製造商應確保設備隨附AnnexI第23節中規定的信息，並以用戶或患者可使用該設備的成員國所確定的官方聯盟官方語言進行交流。標籤上的細節對於預定的使用者或患者而言應是不可磨滅的，易於辨認的和清楚易懂的。
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 authorised representative and importers accordingly.
Where the device presents a serious risk, manufacturers shall immediately 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.製造商認為或有理由相信其投放市場或投入使用的設備不符合本規章的規定，應立即採取必要的糾正措施，使該設備符合要求，撤回該設備或將其銷毀。視情況召回它。他們應將有關設備的分銷商以及相應的授權代表和進口商（如適用）告知經銷商。
13. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.製造商應具有第87條和第88條所述的事件記錄和報告以及現場安全糾正措施的系統。
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 documentation 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 documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.
製造商應應主管當局的要求，向其提供所有必要的信息和文件，以證明該設備的合格性，並以有關成員國確定的正式聯盟語言提供。製造商在其註冊營業地所在的成員國的主管當局可以要求製造商免費提供該設備的樣品，或者在不可行的情況下准許使用該設備。製造商應根據其要求與主管當局合作，採取任何糾正措施，以消除或（如果不可能）減輕其投放市場或投入使用的設備所帶來的風險。
如果製造商未能合作，或者提供的信息和文檔不完整或不正確，主管當局可能會採取一切適當措施，以禁止或限制在其設備在國家市場上使用該設備，以確保保護公眾健康和患者安全。以便從該市場撤回該設備或對其進行召回，直到製造商合作或提供完整且正確的信息為止。
如果主管當局認為或有理由相信設備造成了損壞，則應應要求，協助向可能受到傷害的患者或用戶以及在適當情況下向可能受到傷害的患者或用戶提供第一小節中提及的信息和文件。患者或用戶的所有權繼任者，受患者或用戶損害所影響的患者或用戶的健康保險公司或其他第三方，而不會損害數據保護規則，並且除非在公開中存在壓倒一切的公共利益，且不損害保護知識產權。
15. Where manufacturers have their devices designed or manufactured 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 30(1).如果製造商的設備是由另一法人或自然人設計或製造的，則有關該人身份的信息應作為根據第30條第1款應提交的信息的一部分。
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.
自然人或法人可以根據適用的聯盟和國家法律要求賠償由有缺陷的設備造成的損壞。 製造商應以與風險等級，設備類型和企業規模相稱的方式，採取措施，針對其根據第85/374 / EEC號指令的潛在責任提供足夠的財務保障，而又不影響 國家法律規定的更多保護措施