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that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
（56）
“伦理委员会”是指根据成员国的法律在该成员国设立的一个独立机构，其有权依据本法规要求对临床试验提出意见，该意见应同时考虑到非专业人员，特别是患者或患者组织的意见；‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
（57）
“不良事件”是指在临床研究的背景中，无论是否与研究器械有关，在受试者、使用者或其他人中的任何不良医学事件，非预期的疾病或损伤或任何不利的临床征兆，包括异常的实验室发现；‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
（58）
（a） （b）
死亡 death,，
严重损害受试者的健康，导致以下情况serious deterioration in the health of the subject, that resulted in any of the following:： (i) (ii)
危及生命的疾病或损伤；life-threatening illness or injury,
造成身体结构或身体机能的永久损伤，permanent impairment of a body structure or a body function,
(iii) 住院或延长患者的住院时间；hospitalisation or prolongation of patient hospitalisation, (iv) 医疗或手术干预来防止危及生命的疾病或损伤或身体结构或身体机能的永久损伤，medical
or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v)
（c）
（59）
慢性疾病，chronic disease,
“严重不良事件”是指导致以下任一状况的任何不良事件：‘serious adverse event’ means any adverse event that led to any of the following:
胎儿窘迫、胎儿死亡或先天性身体或精神损伤或先天缺陷；foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
“器械缺陷”是指研究器械的标识、质量、耐久性、可靠性、安全性或性能的任何缺陷，包括制造商提供的信息中的故障、使用错误或缺陷；‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer
(60) “上市后监管”是指制造商与其他经济运营商合作开展的所有活动，目的旨在建立并保持最新的系统化程序，以主动收集和总结从已投放市场、市场上可获得或投入使用的器械获得的经验，以确定是否需要立即采取任何必要的纠正或预防措施；‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to
proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
（61） “市场监管”是指主管当局执行的活动和采取的措施，目的旨在检查和确保器械符合相关欧盟协调立法中规定的要求，并且不危害健康、安全或公共利益保护的任何其他方面；‘market surveillance’ means the activities
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carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
（62） （63） （64）
“召回”是指旨在收回已提供给最终使用者器械所采取任何措施；‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
“撤回”是指旨在防止供应链中的器械进一步在市场上供应的任何措施；‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market; “事件”是指市场上可获得的器械特性或性能的任何故障或劣化事件，包括由于人机工程学特征、制造商提供的信息中的任何不足以及任何不期望的副作用而造成的使用错误；‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
（65）
“严重不良事件”是指直接或间接导致、有可能导致或可能会导致以下任一状况的任何事件：serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: （a） 患者、使用者或其他人员死亡；the death of a patient, user or other person,
（b） 患者、使用者或其他人员健康状态的暂时性或永久性严重恶化；the temporary or permanent serious
deterioration of a patient's, user's or other person's state of health, （c） 严重公众健康威胁；a serious public health threat;
（66） “严重公众健康威胁”是指可能导致死亡风险、健康状态的严重恶化或导致需要对其立即采取补救措施，可
能会导致人类较高发病率或死亡率或在特定地点和时间出现不寻常或意外情况的严重疾病的任何事件；‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
（67） “纠正措施”是指为消除潜在或实际不符合法规要求项目或其他不良情况而采取的措施；‘corrective action’
means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation; （68） “现场安全性纠正措施”是指制造商出于技术或医疗原因采取的纠正措施，目的是防止或降低发生与市场上
供应的器械有关的严重不良事件的风险；‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
（69） “现场安全通知”是指制造商向使用者或客户发送的与现场安全性纠正措施相关的信件；‘field safety notice’
means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action; （70） “协调标准”是指欧盟第1025/2012号法规第2条第（1）（c）点规定的欧盟标准；‘harmonised standard’ means
a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012; （71） “通用规范（CS）”是指一套技术或临床要求，而非对器械的生产或体系提供符合法律要求的标准。‘common
specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
第3条 Article 3
特定定义修改Amendment of certain definitions
委员会有权根据第115条采取授权行为，以基于技术和科技进步并考虑到商定的欧盟和国际层级的定义，调整第2条（18）点所述纳米材料的定义和（19）、（20）和（21）点的相关定义。
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the
definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.
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第4条Article 4
产品监管现状 Regulatory status of products 1.
在不影响第2001/83/EC号指令第2(2)条的情况下，经成员国充分证实的请求，委员会在咨询根据本法规第103条成立的医疗器械协调小组（MDCG）后，应通过实施细则，确定特定产品或某类或某组产品属于医疗器械或“医疗器械的附件”的定义。应按照本法规第114(3)条中述及的审查规程通过这些实施细则。Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the
Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical
device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation. 2.
欧盟委员会也可在咨询MDCG后，自行决议是否通过实施细则确定本条第1段所述的问题。应根据第114（3）条所述检查程序采用这些实施方案。The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 3.
欧盟委员会应确保成员国之间共享体外诊断试剂、医疗器械、药产品、人体组织和细胞、美容剂、灭菌剂、食品和其他产品（如必要）领域的专业知识，以便确定产品或产品类别或产品组的监管状态。The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products. 4.
在审议涉及药品、人体组织和细胞、生物杀灭产品或食品所辖产品监管状况时，委员会应确保欧洲药品管理局（EMA）、欧洲化学品管理局（ECHA）和欧洲食品安全管理局（EFSA）具有的一定的能力可提供咨询。When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European
Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.
第II章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
第5条 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.
3.
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. 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
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general safety and performance requirements shall include a clinical evaluation in accordance with Article 61. 4. 5.
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 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) (ii) (iii)
制造器械的卫生机构的地址和名称；the name and address of the manufacturing health institution; 识别器械的详细信息；the details necessary to identify the devices;
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 design and 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 in point (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 States may 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
institutions shall be considered as having been put into service.
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industrial scale
6.
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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. In order 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).