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本文转载自“木之唐咨询”
前言
疫情肆虐全球，但也终将会过去，让我们静下心来，继续研读法规。
本周我们将分享MDR第二章器械的上市供应和投入使用、经济运营商的义务、再处理、CE标识、自由流通 按我们读完整部MDR法规计划，已分享了法规综述、第一章范围及定义，欢迎关注我们公众号获取更多。
本章 Article 15 对制造商和法规人员提出了新的要求，要求制造商至少配备一名在医疗器械领域具备专业知识和经验的人员负责法规事务。 对法规人员来说，既是机会也是挑战。
CHAPTER II
器械的上市供应和投入使用、经济运营商的义务、再处理、CE标识、自由流通MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Article 5 投放市场和投入使用 Placing on the market and putting into service
1. 仅当器械遵循本法规适当供应并根据其预期用途正确安装、维护和使用时，该器械方可投放市场或投入使用。 A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2. 器械应满足相关载于附录I的通用安全与性能要求，同时考虑到其预期用途。 A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. 3. 通用安全与性能要求的符合性证明应包含符合第61条的临床评价。 Demonstration of conformity with the general safety and performance requirements shall includea clinical evaluation in accordance with Article 61. 4. 应将在卫生机构制造和使用的器械视为已投入使用。 Devices that are manufactured and used within health institutions shall be consideredas having been put into service. 5. 除了附录I中的相关通用安全与性能要求外，此法规的规定不适用于仅在欧盟卫生机构内部生产和使用的器械，前提是能够满足以下条件： With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: （a）该器械不被转移到另一个法律实体， the devices are not transferred to another legal entity, （b）在质量管理体系中制造和使用器械， manufacture and use of the devices occur under appropriate quality management systems, （c）卫生机构在其文件中证明，市场上的相似器械无法达到目标患者群体需要的适当性能水平。 the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market, （d）卫生机构向其主管机构提供了这些器械的使用信息，包括生产、更新和使用的理由； the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use; （e）卫生机构拟定了一份公之于众的声明，包含了 the health institution draws up a declaration which it shall make publicly available, including： (i) 制造器械的卫生机构的地址和名称； the name and address of the manufacturing health institution; (ii) 识别器械的详细信息； the details necessary to identify the devices; (iii) 一份器械满足本法规附录I中设定的通用安全和性能要求的声明，未满足相关要求时，声明中还有相关合理理由， a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable,information on which requirements are not fully met with a reasoned justification therefor, （f）卫生机构拟定文件，以此了解生产设施、制造过程、该器械的设计和性能数据，包括预期用途，足够详细，以使主管机构确定载列于本法规附录I通用安全和性能要求得到满足； the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the designand performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met; （g）卫生机构会采取一切必要措施，以确保所有器械均按照（f）点所述文件中的规定进行生产； the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to inpoint (f), and （h）卫生机构会审查器械的临床使用体验，并采取一切必要的纠正措施。 the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. 成员国可要求卫生机构向主管机构提供更多在其领土上生产和使用器械的相关信息。各成员国有权限制特殊型号器械的生产和使用，且应允许成员国检查卫生机构的活动。 Member Statesmay require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions 本段规定不适用于按工业规模生产的器械。 This paragraph shall not apply to devices that are manufactured on an industrials cale. 6. 委员会可以通过实施细则来确保附录I统一得到应用，且该法案应可达到解决误解和实际应用上的问题的程度。此外，应按照第114(3)条中述及的审查规程通过这些实施细则. Inorder to ensure the uniform application of Annex I, 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 6 远程销售 Distance sales
1. 如欧盟第2015/1535号指令第1(1)条（b）点所规定的，通过资讯社会服务提供给位于欧盟境内的自然人或法人的器械应遵循本法规的要求。 A device offered by means of information society services, as defined inpoint (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation 2. 在不违反国家立法机构对医疗专业活动所做规定的情况下，对于未上市但用于商业活动的器械，无论有偿还是无偿使用，只要是按欧盟第2015/1535号指令第1(1)条（b）点所规定的通过资讯社会服务或其他沟通媒介直接或间接提供给位于欧盟境内的自然人或法人的诊断服务和治疗服务，均应遵循本法规要求。 Without prejudice to national law regarding the exercise of the medical profession, adevice that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation. 3. 应主管机构要求，根据第1段提供器械或根据第2段提供服务的自然人或法人应遵守器械的相关要求，提供一份相关器械的欧盟符合性声明。 Upon request by a competent authority, any natural or legal person offering a devicein accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned. 4.如欧盟第2015/1535号指令第1(1)条（b）点所规定，成员国可以保护公众健康为由，要求资讯社交服务供应商停止其活动。 A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
Article 7 索赔 Claims在贴标签、使用说明、提供服务、投入使用和为器械做广告时，禁止使用误导使用者或患者器械预期使用目的、安全性和性能的文字、名称、商标、图片、图形或其他类似标识，误导手法有： In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks,pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by 说明该器械不具备的功能和特性； ascribing functions and properties to the device which the device does not have; 制造器械有或无的治疗或诊断功能或其他功能和特性的假象； creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; 未告知使用者或患者器械预期用途相关风险； failing to inform the user or the patient of a likely risk associated with the use of the device inline with its intended purpose; 符合性评估完成后，表明器械的用途与预期用途不符。 suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Article 8 使用协调标准Use of harmonised standards
1.符合相关协调标准或相关这些标准的部分的器械，其附于欧盟官方公报中的参考资料应符合本法规的全部和部分要求。 Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. 根据本法规，第一子段也应适用于经济运营商或申办方根据本法规应履行的系统要求或过程要求，包括质量管理体系、风险管理、上市后监管体系、临床研究、临床评价或上市后临床跟踪（PMCF）的相关要求。 The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems,clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). 本法规引用的协调标准参考资料应理解为与发表在欧盟官方公报上的参考资料一致。 References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. 2.本法规中协调标准的引用，还包括根据欧洲药典详述方面，尤其是在手术缝合线方面以及在含有此类医疗产品的器械中用的医药产品与材料之间的相互作用方面的惯例，采用的欧洲药典专著，但前提是这些专著已发表在欧盟官方公报上。 Referencesin this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
Article 9 通用规范 Common specifications1.在不影响第1（2）条和第17（5）条以及其中规定的限期的情况下，若未统一标准存在，或相关协调标准不充分，或者需要解决公共卫生问题，则委员会在咨询MDCG后，可就载列于附录I的通用安全与性能要求、载列于附录II和III的技术文件、载列于附录XIV的临床评价及上市后的临床跟踪或者载列于附录XV有关临床研究的要求，借助实施细则，采用通用规范（CS）。根据第114(3)条中所述的审查程序，应通过实施细则来采纳CS。 Without prejudice to Article 1(2) and17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in AnnexesII and III, the clinical evaluation and post-market clinical follow-up set outin Annex XIV or the requirements regarding clinical investigation set out inAnnex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 2.符合第1段中所述的CS的器械应视为符合本法规中的相关CS要求（全部或部分）。 Devices that are in conformity with the CS referred to in paragraph 1 shall bepresumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. 3.制造商应遵守第1段中所述的CS，除非其能证明其已采纳的方法能够确保等效的安全性和性能水平。 Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto. 4.尽管有第3段的要求，附录XVI所列产品的制造商应遵循这些产品相关的CS。 Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
Article 10 制造商的义务 General obligations of manufacturers1.当将其器械投放市场或投入使用时，制造商应确保所有器械均按本法规的要求进行设计和生产。 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.制造商应如附录I第3节所述，确立、记录、实施和维护风险管理体系。 Manufacturers shall establish, document, implement and maintain a system for risk managementas described in Section 3 of Annex I. 3.制造商应按照载于第61条和附录XIV规定的要求进行临床评价，包括'PMCF'。 Manufacturers shall conduct a clinical evaluation in accordance with the requirements set outin Article 61 and Annex XIV, including a PMCF. 4.除了定制器械外器械的制造商应拟定并更新这些器械的技术文件。该技术文件应允许评定该器械与本法规要求的符合性。该技术文件应包括附录II和III列出的要点。 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. 5.鉴于技术进展和附录II和附录III，根据第115条修订内容，委员会有权批准授权法案。 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. 定制器械制造商应拟定、更新并向主管机构提供符合附录XIII第2节的文档。 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. 若适用的符合性评估流程证明器械符合适用的要求，则器械（非定制或研究用器械）制造商应根据第19条的要求制定欧盟符合性声明，并根据第20条的要求附上标有符合性的CE标识。 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. 制造商应遵守第27条中所述的UDI系统相关义务，以及第29和31条所述的注册义务。 Manufacturers shall comply with the obligations relating to the UDI system referred to inArticle 27 and with the registration obligations referred to in Articles 29 and 31. 8. 制造商应保存技术文件、欧盟符合性声明、适用时还有根据第56条颁发的相关证书及修订件和补充件的副本，在欧盟符合性声明中所涵盖的最后器械上市后，该文档应至少向主管机构开放10年。若为可植入器械，周期应至少为最后器械已投放市场后的15年。 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. 经主管机构要求，制造商应提供完整的技术文件或总结。 Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof. 为使授权代表能够完成第11（3）条中所述的任务，在欧盟境外注册营业的制造商应确保授权代表有永久可用的必要文档。 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. 制造商应确保采取必要程序，以使批量生产符合本法规的要求。应及时充分考虑器械设计或特性的更改和协调标准或器械符合性所声明的CS的更改。器械（非研究用器械）制造商应以最有效的及根据风险等级和器械类别的方式确立、记录、实现、维护、不断更新和不断改善一个能确保器械符合本法规规定的质量管理体系。 Manufacturers shall ensure that procedures are in place to keep series production inconformity 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 amanner that is proportionate to the risk class and the type of device. 质量管理体系包括制造商组织的所有处理流程、程序和器械质量的组成部分。它管理着结构、职责、程序、流程和管理资源，以贯彻所需的原则和行动，以遵守本法规的规定。 The quality management system shall cover all parts and elements of amanufacturer'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. 质量管理体系应至少解决以下方面的问题： The quality management system shall address at least the following aspects: (a)法规符合性战略，包括符合性评估流程的符合性和系统所涵盖的器械的变更管理程序；
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)确定适用的通用安全与性能要求，寻找可选择的解决这些要求的方法； identification of applicable general safety and performance requirements and exploration of options to address those requirements; (c) 管理责任； responsibility of the management; (d) 资源管理，包括选择和管理供应商和分包商； resource management, including selection and control of suppliers and sub-contractor s; (e) 附录I第3节中规定的风险管理； risk management as set out in Section 3 of Annex I; (f) 临床评价，根据第61条和附录XIV的规定，包括PMCF； clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF; (g) 产品实现规划，包括规划、设计、研发、生产和服务提供； product realisation, including planning, design, development, production and service provision; (h) 根据第27（3）条规定验证所有相关器械的UDI分配，确保根据第29条提供的信息的一致性和有效性； verification of the UDI assignments made in accordance with Article 27(3) to all relevant devicesand ensuring consistency and validity of information provided in accordance with Article 29; (j) 根据第83条的要求，建立、实施和维护上市后监管体系； setting-up,implementation and maintenance of a post-market surveillance system, inaccordance with Article 83; (j) 与主管机构、公告机构、其他经济运营商、客户和/或其他利益相关人沟通； handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders; (k) 警戒情况下的严重事件和现场安全纠正措施的报告流程； processes for reporting of serious incidents and field safety corrective actions in the context of vigilance; (l) 纠正措施和预防措施的管理及其有效性的验证； management of corrective and preventive actions and verification of their effectiveness; (m) 产品的监督和测量流程，数据分析和产品改进。 processes for monitoring and measurement of output, data analysis and product improvement. 10. 器械制造商应根据第83条的规定实施并不断更新上市后监管体系。 Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83. 11. 制造商应确保器械附有附录I第23节规定的信息，且信息应采用器械上市国（同时也是成员国）指定的欧盟官方语言编写。标签上的详情应不可拭除、容易识别并且使用者和患者能够清楚理解。 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. 认为或有理由认定其投放于市场或交付使用的器械未遵照本法规的制造商，应立即采取必要纠正措施使器械符合要求，并适时撤回或召回。其应通知所述的器械经销商，并适时通知授权代表和相应进口商。 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. 如器械出现严重风险，制造商应立即通知各成员国主管机构哪些器械可用，如适用，公告机构根据第56条为器械颁发证书，特别是未遵守要求及其采取的纠正措施。 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. 13. 制造商应有一套如第87和88条所述，记录和报告意外事件和现场安全的纠正措施系统。 Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88. 14. 制造商应根据主管机构要求，由相关成员国用官方欧盟语言确定，提供其一切必要信息和文档以证明器械符合要求。如制造商有其注册的营业地点，成员国主管机构可要求制造商免费提供器械样品。如不可行，则授予其器械访问权。制造商应与主管机构合作，按其要求，采取纠正措施以消除风险。如不可行，则降低其已投放市场或投入使用的器械所导致的风险。 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. 若制造商合作失败或提供的信息和文档不完整或不正确，则主管机构为确保保护公众卫生和患者安全，将采取一切必要措施禁止或限制在国内市场采购该器械，从该市场撤回或召回器械直至制造商与主管机构合作，或提供完整且正确的信息。 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. 如主管机构认为或有理由认定器械已造成损害，应当根据要求，协助提供有关第一子段的信息和文档，在不影响数据保护规则，除非在披露凌驾性公众利益，且不影响知识产权保护的前提下，给潜在受伤患者或使用者、患者或使用者的所有权继承人、受伤患者或使用者的医疗保险公司或经受伤患者，或使用者影响的其他第三方。主管机构无须遵守第三子段中有关第一子段所述的信息披露一般是按法律程序进行的义务。 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 obligationlaid 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. 15. 如制造商将其器械交由其他法人或自然人设计和制造，则按照第30（1）条，其法人或自然人的身份信息将成为待提交信息的一部分。 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). 16. 自然人或法人可按照适当欧盟和国家法律，要求对由缺陷器械引起损害进行赔偿。 Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. 根据风险等级、器械类别和企业规模，制造商应采取措施并根据国家法律在不影响更多防护措施的情况下，根据第85/374/EEC号指令，按照其潜在责任提供足够财政保障。 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.
Article 11授权代表 Authorised representative1.当所有成员国器械制造商均未确立时，若制造商指定唯一授权代表，则器械只能投放于欧盟市场。 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 asole authorised representative. 2.委任应构成授权代表的授权书，只有在授权代表书面许可时，且至少在相同种类的所有器械有效时，才有效。 The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group. 3.授权代表应执行其和制造商间授权同意的指定任务。授权代表应根据要求向主管机构提供授权书副本。 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. 授权书应要求且制造商应协助授权代表至少执行相关器械的以下任务： The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) 核实已拟定符合性和技术文件的欧盟声明，且在适当时核实制造商已实施适当符合性评估流程。 verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; (b) 保留一份可用的技术文件、欧盟符合性声明副本。如适用，保留一份包括所有修订和补充的相关证书副本，并按照第56条，在第10(8)条指定时期，由主管机构签发； 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) 遵守第31条规定的注册义务，并核实该制造商已遵守第27和29条规定的注册义务； comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; （d）响应主管机构的要求，提供所有必要信息和文档，采用相关成员国确定的欧盟官方语言，证明器械符合要求； 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 adevice, in an official Union language determined by the Member State concerned; （e）向制造商转达，授权代表具有其经营样品注册地成员国主管机构的所有要求，或访问器械，并核实主管机构收到样品或可访问器械； 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）配合主管机构采取的任何预防或纠正措施以消除或，如不可行，降低由器械导致的风险； 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）立即通知制造商来自医护专业人员、患者和使用者与有关指定器械可疑事件的投诉和举报； 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）如制造商违反本法规义务，则终止授权书。 terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation. 4.本条第3段所述指的授权书不得包括第10（1）、（2）、（3）、（6）、（7）、（9）、（10）、（11）和（12）所规定制造商的义务授权。 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. 在不影响本条第4段的情况下，当所有成员国的制造商都未确立，且未遵守第10条规定义务时，授权代表应与制造商一样为缺陷器械承担法律责任，并一样负有共同连带责任。 Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legallyliable for defective devices on the same basis as, and jointly and severally with, the manufacturer. 6. 根据第3段（h）点所述的理由终止任务的授权代表应立即将任务的终止和原因通知其所在成员国的主管机构，适当时也可通知参与该器械符合性评估的公告机构。 Anauthorised 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. 本法规中对制造商注册营业地的成员国主管机构的任何引用应理解为，根据第1段指定在制造商有注册经营地的授权代表的成员国内，对主管机构的参考地址。 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 授权代表变更 Change of authorisedrepresentative
授权代表变更的详细安排应在制造商间的协议中明确规定，本协议应对即将卸任与新任的授权代表可行。本协议应至少解决以下几个方面： 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: 即将卸任的授权代表，其授权的终止日期为新任授权代表的授权开始日期； the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; 直至授权代表将卸任的日期可在由制造商提供的，包括任何宣传材料的信息上注明； the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; 文件传输，包括机密性方面和产权； the transfer of documents, including confidentiality aspects and property rights; 授权结束后，将即将卸任授权代表的义务转交给制造商或新任授权代表，来自医护专业人员、患者和使用者，与由授权代表指定器械相关可疑事件的投诉和举报。 the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised 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 representative.
Article 13 进口商的一般义务 General obligations ofimporters
1.仅当器械遵照本法规时，进口商才能将器械投入欧盟市场。 Importers shall place on the Union market only devices that are in conformity with this Regulation. 2.为将器械投放市场，进口商应核实以下事项： In order to place a device on the market, importers shall verify that: 该器械已作CE标识，且欧盟器械符合性声明已起草完毕； the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; 制造商已确定，按照第11条，授权代表由制造商来指定； a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer; 该器械按照本法规和要求的使用说明进行标记； the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; 即，如适用，按照第27条，UDI由制造商指定。 where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27. 如进口商认为或有理由相信器械不符合本法规的要求，在器械符合要求前不得将其投放市场，并应通知制造商及其授权代表。如进口商认为或有理由相信该器械出现严重的风险，或为伪造器械，其还应通知进口商所在成员国的主管机构。 Where an importer considers or has reason to believe that a device is not inconformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established. 3.进口商应在器械上或其包装上或随附文件上注明其名称、注册商号或注册商标，及其经营注册地和可联系到进口商的地址，以便确定其位置。它们应确保任何附加标签，不会掩盖制造商提供标签上的任何信息。 Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 4.进口商应核实该器械有按照第29条于电子系统注册。进口商应按照第31条，将其详细资料添加注册。 Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31. 5.进口商应确保器械在其责任、储存或运输条件下，不损害其遵守附录I所列的通用安全与性能要求，且如适用应遵守制造商所列条件。 Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available. 6.进口商应保存不合格器械和召回及撤回投诉记录，并提供制造商、授权代表和经销商以其所要求的所有信息，以便于其进行研究投诉。 Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints 7.如进口商认为或有理由相信其投放到市场上的器械不符合本法规，应立即通知制造商及制造商授权代表。进口商应与制造商、制造商授权代表及主管机构合作，确保已采取必要的纠正措施，如使器械符合要求，撤回器械或召回器械。当器械出现严重风险，其也应立即通知各成员国主管机构哪些器械可用，如适用，公告机构应按照第56条颁发证书，至于有问题的器械，给出细节，特别是未遵守要求及其采取的纠正措施。 Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular,of the non-compliance and of any corrective action taken. 8.如进口商收到来自医护专业人员、患者和使用者，关于投放于市场器械的相关可疑事件的投诉和举报，应立即通知制造商及其授权代表。 Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative. 9.进口商应在第10（8）条所指期间，保留欧盟符合性声明副本，如适用，保留根据第56条发出的，包括所有校正和补充的相关证书副本。 Importers shall, for the period referred to in Article 10(8), keep a copy of 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. 10.进口商应与主管机构合作，按后者要求，采取任何行动以消除或，如不可行，减轻其投放于市场器械导致的风险。进口商按成员国主管机构要求，若进口商有其经营注册地，应提供免费器械样品或，如不可行，允许访问该器械。 Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by acompetent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Article 14 经销商的一般义务 General obligations ofdistributors1.在器械上市时，经销商应在其活动范围内，适当谨慎地执行适用的要求。 When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable. 2.在器械可于市场购得前，经销商应核实是否满足以下要求： Before making a device available on the market, distributors shall verify that all of the following requirements are met: 该器械已作CE标识，且器械欧盟符合性声明已起草完毕； the device has been CE marked and that the EU declaration of conformity of the devicehas been drawn up; 该器械与制造商按照第10（11）条提供的信息相符； the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11); 关于进口器械，进口商已遵守第13（3）条列出的要求； for imported devices, the importer has complied with the requirements set out in Article 13(3); 如适用，制造商已指定UDI。 that, where applicable, a UDI has been assigned by the manufacturer. 为满足第一子段（a）、（b）和（d）点所述要求，经销商可申请由抽样获得的代表性器械。 Inorder to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor. 如经销商认为或有理由相信器械不符合本法规的要求，在器械符合要求前不可将器械推向市场，同时应通知制造商及（如适用）制造商授权代表与进口商。如经销商认为或有理由相信该器械出现严重的风险，或为伪造器械，他还应通知其所在成员国的主管机构。 Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member Statein which it is established. 3.经销商应确保器械在其责任范围内时，储存或运输条件应符合制造商规定。 Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. 4.如经销商认为或有理由相信，投放市场的器械不符合本法规，应立即通知制造商和（如适用）制造商授权代表和进口商。经销商应与制造商、主管机构和（如适用）制造商授权代表与进口商合作，以确保已采取必要的纠正措施，以使器械符合要求、撤回器械或召回器械。如经销商认为或有理由相信该器械出现严重风险，其也应立即通知器械销售所在成员国的主管机构，给出细节，特别是未遵守要求及其采取的纠正措施。 Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in whichit made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. 5.如经销商收到来自医护专业人员、患者和使用者，关于可购得器械相关可疑事件的投诉和举报，应立即将此信息通知制造商和（如适用）制造商授权代表和进口商。其应保存不合格器械和撤回投诉记录，并通知制造商和（如适用）授权代表及经销商此种监控，并按其要求向其提供所有信息。 Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available,the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. 6.应主管机构请求，经销商应自主提供足以证明器械法规符合性的所有资料和文件。当制造商或授权代表（如适用）针对上述器械提供所需信息时，应视为经销商已履行第一子段中所述的该义务。经销商应主管机构要求，配合主管机构，采取任何行动以消除其在市场上所提供器械带来的风险。经销商应主管机构要求提供免费的器械样品，或者若无法提供免费样品，则应授予对器械的访问权。 Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made availableon the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
Article 15 负责法规符合性的人员职责 Person responsible forregulatory compliance1.制造商应在其组织内至少拥有一名在医疗器械领域具有必要专业知识的人员负责法规符合性。必要的专业知识应表现为以下任一一种资格： Manufacturers shall have available within their organisation at least onperson responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertie se shall be demonstrated by either of the following qualifications: 在完成有关成员国确认为同等学历的法律、医学、药学、工程或其他相关科学学科大学学历或学习课程后颁发的文凭、证书或其他正式资格证书，以及在医疗器械相关法规事务或质量管理体系方面具有至少一年专业经验； adiploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or an other relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; 在法规事务或与医疗器械有关的质量管理体系方面有四年的专业经验。 four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. 在不影响关于国家专业资格的规定的情况下，定制器械的制造商可凭借其在相关制造领域至少两年的专业经验证明第一子段所述的所需专门知识。 Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing. 2.在委员会第2003/361/EC号建议（1）含义范围内的微型和小型企业在其组织内无需有负责法规符合性的人员，但应有可永久且持续听其调遣的该类人员。 Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (36)shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. _________________ （1）2003年5月6日关于定义微型和中小型企业的委员会第2003/361/ΕC号建议。CommissionRecommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro,small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). 3.负责法规符合性的人员至少应负责确保以下事项： The person responsible for regulatory compliance shall at least be responsible for ensuring that: 根据制造这些器械的质量管理体系，在器械发布前适当检查器械法规符合性； the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before adevice is released; 制定技术文件和欧盟符合性声明并保持其最新状态； the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 遵守第10（10）)条规定的上市后监管义务； the post-market surveillance obligations are complied with in accordance with Article 10(10); 履行第87至91条中规定的报告义务； the reporting obligations referred to in Articles 87 to 91 are fulfilled; 若为试验用器械，则发出附录XV第XV章第4.1节所述的声明。 in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. 4.若根据第1、2和第3段规定，多人共同负责法规符合性，则其各自的责任领域应以书面形式规定。 If a number of persons are jointly responsible for regulatory compliance inaccordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing. 5.在制造商组织内负责法规符合性的人员，不论其是否属于该组织的雇员，在履行其职责方面不得有任何不利。 The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. 6.授权代表应至少有一名可永久且持续听其调遣的负责法规符合性的人员，其在欧盟境内的医疗器械监管要求方面拥有必要的专业知识。必要的专业知识应表现为以下任一一种资格： Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: （a）在完成有关成员国确认为同等学历的法律、医学、药学、工程或其他相关科学学科大学学历或学习课程后颁发的文凭、证书或其他正式资格证书，以及在体外医疗器械相关法规事务或质量管理体系方面具有至少一年专业经验； adiploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalentby the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating tomedical devices; （b）在法规事务或与医疗器械有关的质量管理体系方面有四年的专业经验。 four years of professional experience in regulatory affairs or in quality management systemsrelating to medical devices.
Article 16 制造商的义务适用于进口商、经销商或其他人的情况 Cases inwhich obligations of manufacturers apply to importers, distributors or otherpersons
1.经销商、进口商或其他自然人或法人若做出以下任何行为，则应承担制造商相应义务： Adistributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: 在市场上提供以其名字、注册商标名称或注册商标命名的器械，除非经销商或进口商与标签上标明的制造商签订协议，仅由制造商承担本法规对制造商规定的要求； make savailable on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters in to an agreement with a manufacturer whereby the manufacturer is identified assuch on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation; 变更已投放市场或投入使用的器械的预期用途； changes the intended purpose of a device already placed on the market or put into service; 更改已投放市场或投入使用的器械，且对符合性产生影响。 modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. 第一子段不适用于为个别患者组装或改装已上市器械（且未更改器械之预期用途）的任何人员（此等人员并不视为第2条第（30）点所定义之制造商）。 The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose. 2.对于第1段（c）点而言，以下情况不得视为器械更改可能影响其适用要求的合规情况： For the purposes of point (c) of paragraph 1, the following shall not beconsidered to be a modification of a device that could affect its compliance with the applicable requirements: 提供附录I第23节规定已投放市场器械的制造商信息，以及用于在相关成员国推销器械所需的进一步信息，包括此等信息的译文； provision,including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State; 对已投放市场器械的外包装改变，若为在相关成员国推销该器械而必需重新包装，且若重新包装不会影响器械原始状态，包括改变包装尺寸，则可进行。对于无菌器械，应保证无菌状态的原始包装，因为重新包装将对必要用于维护无菌状态的包装、损害将会对无菌状态产生不良影响。 changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it.In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened,damaged or otherwise negatively affected by the repackaging. 3. 任何进行第2段（a）及（b）点活动的经销商或进口商应在器械上或者（如不可行）在其包装上或者器械所附的文件上对其所进行的活动标明其名称、注册商标名或者注册商标、业务注册地及有效联系地址及设立位置。 经销商和进口商应确保具有一套质量管理体系，其中的流程应保证信息译文准确及时更新，还应保证在保持器械原始状态不变的方式和条件进行第2段（a）和（b）点中的活动以及保证重新包装的器械包装应无缺陷，质量良好且整洁。质量管理体系除此之外还应包括这些程序：确保经销商或进口商充分了解任何有关安全问题或合规问题的纠正行动。 A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the deviceor, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered tradename or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established. Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a)and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation. 4.至少在对上市器械重贴标签或重新包装28天前，进行第2段第（a）和（b）点中所述活动的经销商或进口商，应通知在中所述的拟提供重贴标签或重新包装器械的制造商和所在成员国主管机构，并根据要求应向制造商和主管机构提供一个重贴标签或重新包装器械的样品或实体模型，包括任何翻译版本的标签和说明书。在该28天内的同一时期内，其应当向主管机构提交一份证书，该证书由公告机构颁发给用于进行第2段（a）和（b）点所述活动器械，用于证明该经销商或进口商质量管理体系符合在第3段中规定的要求。 At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned inpoints (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
Article 17一次性使用器械及其再处理 Single-use devices andtheir reprocessing
1.一次性使用器械的再处理和进一步使用只能在国家法律允许的情况下进行，且只能按照本文进行. Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article. 2.任何对一次性使用器械进行再处理以使其适合在欧盟内进一步使用的自然人或法人应视为再处理器械的制造商，并承担本法规所规定的制造商义务，包括根据本法规第III章，与再处理器械可追溯性有关的义务。对于第85/374/EEC号指令第3(1)条的目的，器械再处理者应视为生产者。 Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC. 3.通过对第2段的豁免，对于在卫生机构中再处理和使用的一次性使用器械，成员国可决议不采用与本法规中规定的制造商义务有关的所有规则，但前提是其确保 By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers' obligations laid down in this Regulation provided that they ensure that:： 再处理器械的安全性和性能与原器械的安全性和性能相同，且遵循第5（5）条（a）、（b）、（d）、（e）、（f）、（g）和（h）点中的要求； thesafety and performance of the reprocessed device is equivalent to that of theoriginal device and the requirements in points (a), (b), (d), (e), (f), (g) and(h) of Article 5(5) are complied with; 根据CS执行再处理，其中详细说明以下方面的要求： the reprocessing is performed in accordance with CS detailing the requirements concerning: 关于风险管理，包括对器械的结构和材料，相关属性的分析（逆向工程）和检测原器械以及再处理后计划应用的设计变更程序， risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing, 关于验证整个过程程序，包括清洁步骤， the validation of procedures for the entire process, including cleaning steps, 关于产品的上市和性能测试， the product release and performance testing, 关于质量管理体系， the quality management system, 关于涉及已进行再处理的器械事件报告， the reporting of incidents involving devices that have been reprocessed, and 关于再处理器械的可追溯性。 the traceability of reprocessed devices. 成员国应鼓励并要求卫生机构向患者提供关于在卫生机构内使用再处理器械的信息，并酌情提供患者治疗采用的再处理器械的任何其他相关信息。 Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and,where appropriate, any other relevant information on the reprocessed devices that patients are treated with. 成员国应将根据本段提出的国家规定和提出这些规定的理由通知委员会和其他成员国。委员会应将信息公开。 Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available. 4.成员国可选择采用第3段所述的规定，也适用于应卫生机构的要求由外部再处理者再处理的一次性使用器械，但前提是将再处理器械全部返回该卫生机构，并且外部再处理者遵循第3段第（a）和（b）点中所述的要求。 Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3. 5.委员会应根据第9(1)条，自2020年5月26日起采用第3段第（b）点中所述的必要CS。这些CS应符合最新科学证据，并应适用于本法规所规定的关于安全与性能的一般要求。若自2020年5月26日起未采用CS，则应根据任何包括在第3段第（b）点中所列方面相关协调标准和国家规定进行再处理。符合通用规范，或在无通用规范的情况下，相关协调标准和国家规定应由公告机构进行认证。 The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in this Regulation. In the event that those CS are not adopted by 26 May 2020,reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined inpoint (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body. 6. 根据第93/42/EEC号指令，仅有按照本法规或在2020年5月26日之前投放市场的一次性使用器械可进行再处理。 Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed. 7. 只能对根据最新科学证据视为安全的一次性使用器械进行再处理。 Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out. 8. 第2段中所述的法人或自然人的姓名和地址以及附录I第23节中规定的其他相关信息，应在标签上标明，并在适用的情况下在再处理器械的使用说明中注明。 The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device. 一次性使用器械原制造商的名称和地址不再出现在标签上，但应在再处理器械的使用说明书中所述。 The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device. 9. 允许一次性使用器械再处理的成员国可维持或实行比本法规规定及限制或禁止更严格的国家规定，并在其领土内限制或禁止实施以下行为： A Member State that permits reprocessing of single-use devices may maintainor introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following: 一次性使用器械的再处理以及为进行再处理而将一次性使用器械转移至另一成员国或第三国； the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; 再处理的一次性使用器械的提供或进一步使用。 the making available or further use of reprocessed single-use devices. 成员国应将国家规定通知委员会和其他成员国。委员会应将该信息公开。 Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available. 10.委员会应在2024年5月27日起草关于本条实施情况的报告，并将其提交欧洲议会和理事会。根据本报告，委员会应酌情提出修订修订本法规的建议。 The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Article 18 将提供给患者的植入器械植入物卡和信息
Implant card and information to be supplied to the patient with an implanted device1.可植入器械的制造商应连同该器械一起提供以下内容： The manufacturer of an implantable device shall provide together with the device the following (a) 器械标识信息，包括器械名称、序列号、批号、UDI、器械型号，以及制造商名称、地址和网站； information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer; (b) 患者或医疗保健专业人员对可合理预见的外部影响、医学检查或环境条件的相互干扰采取的任何警戒、预防措施或举措； any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions; (c) 关于器械的使用期限的任何信息和任何必要的跟踪； any information about the expected life time of the device and any necessary follow-up; (d) 任何其他确保患者安全使用该器械的信息，包括附录I第23.4节第（u）点的信息。 any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I. 出于提供给特殊患者目的，在第一子段总所述的信息应通过任何方式提供给已植入器械的特定患者，使其可快速获取信息，并以相关成员国确定的语言表述。信息的表达方式应使非专业人士容易理解并应酌情更新，且应通过第1段（a）点所述的网站向患者提供更新信息。 The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph 此外，制造商应在与器械一起交付的植入物卡片上提供第一子段（a）点规定的信息。 In addition, the manufacturer shall provide the information referred to inpoint (a) of the first subparagraph on an implant card delivered with the device 2.成员国应要求卫生机构过允许患者快速获取信息，并向已进行器械植入且具有其身份的植入物卡的患者提供第1段中所述的信息。 Member States shall require health institutions to make the information referred to inparagraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity. 3. 以下植入物应免除本文规定的职责：缝合线、U形钉、牙齿填料、牙弓、牙冠、螺钉、楔子、板线、针、夹子和连接器。委员会有权根据第115条采用授权方案，通过增加其他类植入物或从中删除植入物来修订这一清单。 The following implants shall be exempted from the obligations laid down in this Article: sutures,staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates,wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by addingother types of implants to it or by removing implants therefrom.
Article 19 欧盟符合性声明 EU declaration of conformity
1.欧盟符合性声明须说明已履行本法规中相关涵盖器械规定的要求。制造商应当不断更新欧盟符合性声明。欧盟符合性声明至少应包括列于附录IV的信息，且应将其翻译成欧盟官方语言或者器械销售所在成员国所要求的语言。 The EU declaration of conformity shall state that the requirements specified in this Regulationhave been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available. 2. 就本法规未涵盖的相关问题，若器械需遵守其他欧盟立法机构要求（该立法机构要求制造商发布一份证实已履行该立法机构所规定要求的欧盟符合性声明），只需要起草有关所有欧盟法案均适用该器械的单独符合性声明。这一声明应包含所有标识声明书相关欧盟立法机构的必要信息。 Where,concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up inrespect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates. 3.通过起草欧盟符合性声明，制造商应承担遵守本法规和适用于器械的所有其他欧盟立法机构要求的责任。 By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device. 4.委员会应有权按照第115条规定通过授权法案，基于技术进步来修订附录IV规定的欧盟符合性声明的最低限度内容。 The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Article 20 CE符合性标识 CE marking of conformity1.除了定制或研究用器械外，视为符合本法规要求的器械应加贴如附录V中所示的合规CE标识。 Devices, other than custom-made or investigational devices, considered to be inconformity with the requirements of this Regulation shall bear the CE markingof conformity, as presented in Annex V. 2.CE标识应遵守列于欧洲委员会第765/2008号法规第30条要求的一般原则。 The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 3.标签应明显、清晰和不可磨灭地添加在器械或其无菌包装上。考虑到器械性质，无法或不适合将标签添加到器械上时，应将CE标识添加在包装上。CE标识也应加贴在有使用说明和任何销售包装中。 The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging.The CE marking shall also appear in any instructions for use and on any sales packaging. 4.应在器械上市前加贴CE标识。其可能紧跟在任一个表示特殊危险或用途的象形图或任何其他标记后面。 The CE marking shall be affixed before the device is placed on the market. It maybe followed by a pictogram or any other mark indicating a special risk or use. 5.如适用，CE标识应紧跟在负责进行列于第52条的符合性评估流程的公告机构标识号后面。且应在任何宣传材料（其中所述器械满足CE标识的要求）中说明标识号。 Where applicable, the CE marking shall be followed by the identification number ofthe notified body responsible for the conformity assessment procedures set outin Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking. 6.若器械需遵守欧盟立法机构要求添加CE标识的其他规定，则CE标识还应表明该器械符合其他立法机构要求。 Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
Article21 用于特殊用途的器械 Devicesfor special purpose
1.成员国不得造成任何障碍： Member Statesshall not create obstacles to: 提供给研究员用于临床研究的试验用器械，前提是在根据第81条和附录XV规定执行采用的法案时，符合第62条至第80条和82条所规定的条件； investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adopted pursuant to Article 81 and in Annex XV; 2.可在市场上提供的定制器械，前提是符合第52（8）条和附录XIII的规定。 custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with 在第一子段中所述的器械（在第74条中所述的器械除外）不得加贴CE标识。 The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74. 定制器械应附有附录XIII第1节所述的声明，该声明应提供给以名称、首字母缩略词或数字代码标识的特定患者或使用者。 Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall be made available to the particular patient or user identified by name, an acronym or a numerical code. 成员国可要求定制器械的制造商向主管机构提交在其领土内可获得的此类器械的清单。 Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory 3.在交易会、展览会、展示会或类似活动上，成员国不得制造任何障碍，表明器械不符合本法规要求，但前提是在器械上清楚标明一个明显记号表明该器械仅用于展示或演示目的且在未符合本法规之前不可投入使用。 At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devicesare intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
Article 22系统和手术包 Systems and procedure packs1.任何自然人或法人若根据器械或其他产品的预期用途并在制造商指定的使用限制范围内，将带有CE标识的器械与下列其他器械或产品一起组合，则应起草第2段所述的声明，以将它们作为系统或手术包投放市场： Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack: 其他带CE标识的器械；other devices bearing the CEmarking; 带有符合欧盟第2017/746号法规的CE标识的体外诊断医疗器械； invitro diagnostic medical devices bearing the CE marking in conformity withRegulation (EU) 2017/746; 仅在其在医疗程序中使用或证明其在系统或手术包中另外存在时，才符合适用于这些产品的立法的其他产品。 other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is other wise justified. 2.在第1段中所做的说明中，自然人或法人应声明如下： In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that: 其已根据制造商的说明验证了器械和其他产品（如适用）间的相互兼容性，并根据这些说明执行了其活动； they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions; 其将系统或手术包打包并向使用者提供相关信息，其中整合了器械或其他同一包装内产品制造商应当供应的信息； they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together; 将器械和其他产品（如适用）作为系统或手术包进行组合的活动需要采用适当的内部监测、验证和确认方法。 the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring,verification and validation. 3.对第1段所述的系统或手术包进行消毒并将其投放市场的任何自然人或法人，应在其选择下遵循附录IX或附录XI的A部分所述的程序之一。这些程序的应用和公告机构的参与应限于确保灭菌直至无菌包装打开或损坏的程序层面。该自然人或法人应起草一份声明书，声明已按照制造商的说明进行灭菌。 Any natural or legal person who sterilises systems or procedure packs referred to inparagraph 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions. 4.若系统或手术包包含不带CE标识的器械，或所选择的器械组合由于其原始预期用途而不兼容，或未根据制造商的说明进行消毒，则系统或手术包应视为独立的器械，并应依照第52条进行相关的符合性评估流程。此外，自然人或法人应承担制造商的义务。 Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible inview of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the systemor procedure pack shall be treated as a device in its own right and shall besubject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers. 5.本条第1段所述的系统或手术包本身不得带附加CE标识，但应带有本条第1段和第3段所述人员的姓名、注册商标名称或注册商标以及可与其联系并确定该人员位置的地址。系统或手术包应附有附录I第23节所述的资料。在将系统或手术包组合后，在适用于根据第10（8）条组合的器械的期间，将本条第2段所述的声明交由主管机构保管处置。若这些期间不同，则应采用最长的期间。 The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person's location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to inparagraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply.
Article 23 部件和组件 Parts and components1.任何在市场上提供专门用于取代相同或类似的有缺陷或磨损器械组成部分或组件的物品，以维持或恢复器械功能的自然人或法人，应在不改变器械性能或安全特征或其预期用途情况下，保证该物品对器械安全与性能没有不利影响。支持性证据应可供成员国主管机构随时获取。 Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of adevice that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States. 2.专门用于替代器械部件或组件和显著改变器械性能或安全特征或预期用途的物品，应视为器械且应满足本法规规定的要求。 An item that is intended specifically to replace a part or component of a deviceand that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.
Article 24自由流通 Free movement除非本法规另有规定，否则成员国不得拒绝、禁止或限制在其领土内提供或使用符合本法规要求的器械。 Except where other wise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation.
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发表于 2020-5-11 13:58:18