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law by virtue of that person's professional qualifications which gives, under that person's responsibility,
specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs
但需要通过调整以满足任何专业使用者特殊要求的大规模生产的器械，且根据经授权人员的书面处方通过工业生产过程大规模生产的器械不得视为定制器械；However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial
manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
(4)
“有源器械”是指任何器械，其操作依靠除了人体或通过重力产生能量源外的能量来源，并且其通过改变该能量的密度或转换该能量而发挥作用。用于在有源器械和患者间传输能量、物质或其他元素而无任何显著变化的器械不得视为有源器械。‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. 软件应被视为有源器械；Software shall also be deemed to be an active device
(5)
“可植入器械”指任何器械，包括部分或完全被吸收的器械，其通过临床干预用于‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
– 完全植入人体或to be totally introduced into the human body, or
– 取代上表皮或眼睛表面，to replace an epithelial surface or the surface of the eye,
并且在手术后保持原样。任何用于通过临床干预部分引入人体并且在手术后保持原样至少30天的器械也应视为可植入器械；by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
(6)
“侵入式器械”是指通过人体自然通道或人体表面穿入人体的任何器械；‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;
(7)
“通用器械组”是指具有相同或类似预期用途或相同技术的一组器械，允许以不反映特定属性的通用方式对其进行分类；generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(8)
“一次性使用器械”是指在单次使用且仅用于一个人的器械。‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
（9） “伪造器械”是指其标识和/或来源和/或CE标识证书或与CE标识程序相关文件为虚假伪造的器械。此定义不
包含无意的不合规，并且不影响知识产权的侵犯。‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;
（10） “器械包”是指包装在一起并投放市场用于特定医疗目的产品的组合；‘procedure pack’ means a combination of
products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
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（11） “系统”是指包在一起或未包在一起的，用于相互连通或组合以实现特定医疗目的产品组合；system’ means a
combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
（12） “预期用途”是指制造商根据标签、说明书、促销或销售材料或声明中所提供的数据在临床评价中指定的用途；
intended purpose’ means the use for which a device is intended according to the data supplied by the
manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
（13） “标签”是指出现在器械本身，或在各装置包装上或多个器械包装上的印刷文字或图形类的信息；‘label’ means
the written, printed or graphic information appearing either on the device itself, or on the packaging of each
unit or on the packaging of multiple devices;
（14） “说明书”是指由制造商提供，用以告知器械使用者该产品的预期用途、正确使用方法以及注意事项的信息。
‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
（15） “唯一器械标识”（UDI）是指通过国际认可的器械标识和编码标准创建的一系列数字或字母数字字符，并允许
明确识别市场上的特定器械；Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that
allows unambiguous identification of specific devices on the market;
（16） “非活性”是指没有代谢或繁殖的潜力；‘non-viable’ means having no potential for metabolism or
multiplication;
（17） “衍生物”是指通过生产过程从人或动物组织或细胞提取的“非细胞物质”。在这种情况下，用于制造器械的最
终物质不得含有任何细胞或组织；derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in
this case does not contain any cells or tissues;
（18） “纳米材料”是指含有颗粒的一种天然或人工制造材料（），该材料以游离状态或作为一种集合体或作为一种结
块存在，粒径分布中颗粒到达50%或更多，具有一个或多个外部尺寸，尺寸范围介于1 nm-100 nm之间。nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state
or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
具有一个或多个低于1nm的外部尺寸的富勒烯、石墨烯薄片和单壁碳纳米管应视为纳米材料；Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;
（19） “颗粒”，就第(18)点中纳米材料的定义而言，是指具有确定物理边界的一小块物质；particle’, for the purposes
of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical
boundaries;
(20)
“附聚物”，就第(18)点中纳米材料的定义而言，是指弱结合的颗粒或聚集体的集合，其中外表面积与各个成分的表面积总和相同；agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
(21)
“聚集体”，就第(18)点中纳米材料的定义而言，是指包含强结合的颗粒或熔合颗粒；‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;
(22)
“性能”是指器械实现制造商要求的预期用途的能力；‘performance’ means the ability of a device to achieve its
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intended purpose as stated by the manufacturer;
(23)
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“风险”是指危害发生概率和危害严重性的组合。risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
(24) “利益风险评估”是指在根据制造商规定的预期用途使用器械时，与预期用途相关的所有利益和风险评估的分
析；benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
(25)
“相容性”是当根据其预期用途与一个或多个其他器械一起使用时，器械（包括软件）的能力：compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
（a） 执行而不失去或损害执行预期使用目的能力，和/或 perform without losing or compromising the ability to perform as intended, and/or
（b） 整合和/或操作而不需要修改或调整器械任何部分的功能，和/或 integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
（c） 在没有冲突/干扰或不良反应的情况下一起使用的能力。be used together without conflict/interference or adverse reaction.
(26) “互操作性”是指来自相同制造商或不同制造商的两个或更多器械（包括软件）的以下能力 ‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
（a） 交换信息并能通过所交换的信息来为执行指定功能而不改变数据内容的能力，和/或 exchange
information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or （b） 相互通信的能力，和/或 communicate with each other, and/or （c） 按照预期用途一同运作work together as intended。 (27)
“在市场上可获得”是指在商业活动过程中于欧盟市场上分配、消费或使用的任何器械（除了用于研究器械外）的任何供应（不论其是付费或免费供应）；‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(28) (29)
“市场投放”是指在欧盟市场上首次提供除研究器械以外的器械； ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market
“投入使用”是指器械（用于研究的器械除外）可供最终使用者使用以准备在欧盟市场上首次用于其预期使用目的阶段；‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
(30)
“制造商”是指制造或全面翻新器械或具有设计、制造或全面翻新的器械并以其名称或商标销售该器械的自然人或法人。‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;
(31)
“全面翻新”，基于制造商的定义，是指已投放市场或投入使用的器械全面翻新，或者利用已使用的器械制造新器械，以使其符合本法规，并赋予翻新的器械新的寿命；‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with
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the assignment of a new lifetime to the refurbished device;
(32)
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“授权代表”是指在欧盟境内确定的任何自然人或法人，其收到并接受位于欧盟以外的制造商的书面授权，代表该制造商按照本法规对制造商所规定的义务要求所进行的一切行动；‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
(33) “进口商”是指在欧盟内确定的任何自然人或法人，其来自器械投放于欧盟市场的第三国；‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
(34) “经销商”是指供应链中除了制造商或进口商外的任何自然人或法人，其负责从器械投放市场到投入使用的整个过程；distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
(35) “经济运营商”是指制造商、授权代表、进口商、经销商和第22(1)和22(3)条的所指人员；economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
(36) (37) (38) (39)
“卫生机构”是指以护理抑或治疗疾病或促进公众健康为目的组织；health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
“使用者”是指使用器械的任何医护专业人员或非专业人员；‘user’ means any healthcare professional or lay person who uses a device;
“非专业人员”是指未在相关医疗卫生或医学学科领域接受正规教育的个人；‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
“再处理”是指在使用过的器械上进行的处理过程，以便允许其安全再利用，包括清洁、消毒、灭菌和相关程序，以及测试和恢复所用器械的技术和功能安全性；‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
(40) （41）
“符合性评估”是指证明本法规中与器械相关的要求是否得到满足的过程；‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; “符合性评估机构”是指执行第三方符合性评估活动的机构，活动包括评估、检查、认证和审核；conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
（42） （43）
“公告机构”是指根据本法规指定的符合性评估机构；notified body’ means a conformity assessment body designated in accordance with this Regulation
“CE合格标识”或“CE标识”是指制造商为表明该器械符合本法规和其他适用的欧盟协调立法对其标识规定的适用要求而使用的标识；‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
（44） “临床评价”是指，连续地产生、收集、分析和评估与器械有关的临床数据的一个系统化的流程，目的是为验证按照制造商所规定的预期用途使器械用器械的安全性及性能包括临床收益；‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
（45） “临床研究”是指对一个或多个受试者进行的任何系统性研究，以评估器械的安全性及产品性能；‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to
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assess the safety or performance of a device;
（46） （47）
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“研究器械”是指在临床研究中评估的任何器械；‘investigational device’ means a device that is assessed in a clinical investigation;
“临床研究计划”是指说明临床研究的理论、目标、设计、方法、监察、统计方法、组织和施行方案的文件；‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
（48） “临床数据”是指与器械使用产生以及源于以下内容的安全或性能有关的信息：clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
– –
有关器械的临床研究clinical investigation(s) of the device concerned,，
器械（指可证明其与待考核器械具有等效性的器械）的临床研究或在科学文献中报告的其他研究，clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
–
在同行评审的科学文献中发表的关于所讨论器械或可以证明与该器械等效的另一种器械的其他临床经验报告reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
–
（49）
来自上市后监管体系的其他临床数据，特别是上市后临床跟踪；clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
“申办方”是指负责启动、管理临床研究和设立临床研究融资的任何个人、公司、机构或组织；‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the
management and setting up of the financing of the clinical investigation;
（50） （51）
“受试者”是指参与临床研究的个体；‘subject’ means an individual who participates in a clinical investigation; “临床证据”是指关于足够数量和质量的器械的临床数据和临床评价结果，以允许在制造商按预期使用时，对器械是否安全并达到预期临床受益进行符合性评估；‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
（52） “临床性能”是指器械因技术或功能特性包括诊断特性产生的任何直接或间接医学效应，以在使用时器械时实现其制造商要求的预期用途从而使临床患者受益的能力的；‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics,
including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
（53） “临床受益”是指器械对个体健康的积极影响，被指定为有意义、可测量、与患者相关的临床结果，包括与诊断相关的结果或对患者管理或公共卫生的积极影响；‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.
（54） （55）
“研究员”是指负责在临床研究现场进行临床研究的个人；‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
“知情同意”是指受试者在参与临床试验前，被告知与其参与的临床研究所有相关问题后自由和自愿地表达他或她参与特定临床研究的意愿，或者对于未成年人和无行为能力的受试者，在临床研究中应包括其法定代表的授权书或协议；‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation