Article 2 Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compen sation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
(I) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
and which does not achieve its principal intended action by phar macological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
(3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifi cations 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.
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 manu facturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
(4) ‘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.
Software shall also be deemed to be an active device;
(5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye,
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) ‘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) ‘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) ‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
(9) ‘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) ‘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;
(11) ‘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) ‘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) ‘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) ‘instructions for use’ means the information provided by the manu facturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
(15) ‘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) ‘non-viable’ means having no potential for metabolism or multi plication;
(17) ‘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) ‘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; 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) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;
(20) ‘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) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;
(22) ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
(23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
(24) ‘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) ‘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) perform without losing or compromising the ability to perform as intended, and/or
(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse reaction.
(26) ‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufac turers, to:
(a) 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) communicate with each other, and/or
(c) work together as intended.
(27) ‘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) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
(29) ‘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) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manu factured or fully refurbished, and markets that device under its name or trade mark;
(31) ‘fully refurbishing’, for the purposes of the definition of manu facturer, 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 the assignment of a new lifetime to the refurbished device;
(32) ‘authorised representative’ means any natural or legal person estab lished 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) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
(34) ‘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) ‘economic operator’ means a manufacturer, an authorised represen tative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
(36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
(37) ‘user’ means any healthcare professional or lay person who uses a device;
(38) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
(39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, ster ilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
(40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
(41) ‘conformity assessment body’ means a body that performs third- party conformity assessment activities including calibration, testing, certification and inspection;
(42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
(43) ‘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) ‘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) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
(46) ‘investigational device’ means a device that is assessed in a clinical investigation;
(47) ‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
(48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
— clinical investigation(s) of the device concerned,
— clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
— 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 demon strated,
— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
(49) ‘sponsor’ means any individual, company, institution or organis ation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical inves tigation;
(50) ‘subject’ means an individual who participates in a clinical inves tigation;
(51) ‘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) ‘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) ‘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) ‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
(55) ‘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 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 rep resentative to include them in the clinical investigation;
(56) ‘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 Regu lation, taking into account the views of laypersons, in particular patients or patients' organisations;
(57) ‘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) ‘serious adverse event’ means any adverse event that led to any of the following:
(a) death,
(b) serious deterioration in the health of the subject, that resulted in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
(59) ‘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) ‘post-market surveillance’ means all activities carried out by manu facturers 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) ‘market surveillance’ means the activities 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) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
(63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
(64) ‘incident’ means any malfunction or deterioration in the characte ristics 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) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
(c) a serious public health threat;
(66) ‘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) ‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
(68) ‘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) ‘field safety notice’ means a communication sent by a manu facturer to users or customers in relation to a field safety corrective action;
(70) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
(71) ‘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.
就本法规而言,以下定义适用:
(1)“医疗设备”是指制造商打算将其单独或组合用于人类的一种或多种下列特定医学用途的仪器,设备,器具,软件,植入物,试剂,材料或其他物品用途:
—疾病的诊断,预防,监测,预测,预后,治疗或缓解,
—对伤害或残疾的诊断,监测,治疗,缓解或补偿,
-对解剖结构或生理或病理过程或状态的调查,替换或修改,
-通过体外检查人体来源的标本提供信息,包括器官,血液和组织的捐赠,
(I)欧洲议会和理事会于2006年5月17日发布的关于机械的指令2006/42 / EC,并修订了指令95/16 / EC(OJ L 157,9.6.2006,第24页)。
并不能通过药理,免疫或代谢手段在人体内或人体上实现其主要预期作用,但可以通过这种方式辅助其功能。
以下产品也应视为医疗设备:
—控制或支持受孕的设备;
-专门用于第1条第(4)款所述的设备以及本节第1款所述的设备的清洁,消毒或灭菌的产品。
(2)“医疗器械附件”是指其本身并非医疗器械,但制造商打算与一种或几种特定医疗器械一起使用的物品,以专门使该医疗器械有效)可根据其预期目的使用,或根据其预期目的专门并直接辅助医疗设备的医疗功能;
(3)“定制设备”是指根据该人的专业资格,根据该人的专业资格,根据国家法律授权的任何人的书面处方专门制造的任何设备,该设备在该人的责任下具有特定的设计特征,并且旨在仅用于满足特定患者的具体条件和需求的特定患者。
但是,需要调整以适应任何专业用户的特定要求的批量生产的设备,以及根据任何授权人员的书面规定通过工业制造过程进行批量生产的设备,均不应视为是合格产品。定制设备;
(4)“主动装置”是指任何装置,其操作取决于人类为此目的或重力产生的能量以外的其他能量,并通过改变能量的密度或转换该能量而起作用。旨在在有源设备和患者之间传递能量,物质或其他元素而无任何重大变化的设备,不应被视为有源设备。
软件也应被视为活动设备;
(5)“可植入装置”是指旨在:
-完全引入人体,或
-替换上皮表面或眼睛表面,
通过临床干预,并打算在手术后保留。
任何打算通过临床干预部分引入人体并在手术后至少保留30天的位置的器械,也应视为可植入器械;
(6)“侵入性器械”是指通过体孔或体表全部或部分穿透体内的任何器械;
(7)“通用设备组”是指一组具有相同或相似预期用途或技术通用性的设备,允许它们以不反映特定特征的通用方式进行分类;
(8)“单次使用设备”是指旨在在单个过程中供一个人使用的设备;
(9)“伪造的设备”是指任何带有虚假的身份和/或其来源和/或CE认证证书或与CE认证程序有关的文件的设备。该定义不包括无意间的违规行为,并且不影响知识产权的侵犯;
(10)“程序包”是指包装在一起并投放市场以用于特定医疗目的的产品的组合;
(11)“系统”是指旨在相互连接或组合以实现特定医疗目的的产品组合,无论是否包装在一起;
(12)“预期用途”是指根据制造商在标签上提供的数据,使用说明或促销或销售材料或声明中以及制造商在临床上指定的用途,打算将设备用于该用途评估;
(13)“标签”是指出现在设备本身,每个单元的包装或多个设备的包装上的书面,印刷或图形信息;
(14)“使用说明”是指制造商提供的信息,用于告知用户设备的预期用途和正确使用以及应采取的任何预防措施;
(15)“唯一设备标识符”(UDI)是指一系列数字或字母数字字符,这些字符是通过国际公认的设备识别和编码标准创建的,可以明确识别市场上的特定设备;
(16)“不可行”是指没有新陈代谢或繁殖的潜力;
(17)“衍生物”是指通过制造过程从人或动物组织或细胞中提取的“非细胞物质”。在这种情况下,用于制造设备的最终物质不包含任何细胞或组织。
(18)“纳米材料”是指天然的,附带的或制造的材料,其中包含处于未结合状态或作为聚集体或作为附聚物的颗粒,并且对于数量尺寸分布中50%或更多的颗粒,其一个或多个外部尺寸尺寸范围为1-100 nm;
一个或多个外部尺寸小于1 nm的富勒烯,石墨烯薄片和单壁碳纳米管也应视为纳米材料;
(19)就第(18)点中的纳米材料的定义而言,“粒子”是指具有定义的物理边界的微小物质;
(20)就第(18)点中的纳米材料的定义而言,“团聚体”是指弱结合的颗粒或聚集体的集合,其中所得的外部表面积类似于各个组件的表面积之和;
(21)就第(18)点中的纳米材料的定义而言,“聚集体”是指由牢固结合或融合的颗粒组成的颗粒;
(22)“性能”是指设备达到制造商规定的预期目的的能力;
(23)“风险”是指损害发生的可能性和损害的严重程度;
(24)“受益风险确定”是指在按照制造商给出的预期目的使用时,对与将设备用于预期目的相关的所有收益和风险评估的分析;
(25)“兼容性”是指一种设备(包括软件)根据其预期目的与一个或多个其他设备一起使用时的能力:
(a)在不丧失或不损害其预期表现的能力的前提下,和/或
(b)集成和/或操作,而无需修改或改编组合设备的任何部分,和/或
(c)一起使用而不会产生冲突/干扰或不良反应。
(26)“互操作性”是指来自同一制造商或不同制造商的两个或更多个设备(包括软件)具有以下能力:
(a)交换信息并使用为正确执行指定功能而交换的信息,而无需更改数据的内容,和/或
(b)互相交流,和/或
(c)按计划一起工作。
(27)“在市场上出售”是指在商业活动过程中,在联盟市场上以供销售,分发或消费的方式使用除研究用设备以外的任何设备,无论是付费还是免费。 ;
(28)“投放市场”是指在联盟市场上首次提供除研究性设备以外的其他设备;
(29)“投入使用”是指最终用户可以使用的设备,而不是研究设备,已准备好首次用于联盟市场以达到其预期目的;
(30)“制造商”是指自然人或法人,其制造或完全翻新设备,或设计,制造或完全翻新设备,并以其名称或商标销售该设备;
(31)就制造商的定义而言,“全面翻新”是指完全重建已经投放市场或投入使用的设备,或由二手设备制造新设备以将其投入生产。符合本法规,并为翻新设备分配新的使用寿命;
(32)“授权代表”是指在联盟内部建立的任何自然人或法人,已经接受并接受了联盟外部制造商的书面授权,可以代表制造商就涉及以下方面的特定任务采取行动:后者在本法规下的义务;
(33)“进口商”是指联盟内部建立的将第三国的设备投放到联盟市场上的任何自然人或法人;
(34)“分销商”是指供应商中除制造商或进口商之外的任何自然人或法人,该人可以将设备投放市场,直至投入使用为止;
(35)“经济运营商”是指制造商,授权代表,进口商,分销商或第22条第1款和第22条第3款所述的人;
(36)“医疗机构”是指主要目的是照顾或治疗患者或促进公共卫生的组织;
(37)“用户”是指使用设备的任何医疗保健专业人员或非专业人士;
(38)“非专业人士”是指未在医疗保健或医学学科的相关领域中接受过正规教育的个人;
(39)“再处理”是指在使用过的设备上进行的过程,以使其安全地重复使用,包括清洁,消毒,灭菌和相关程序,以及测试和恢复使用过的设备的技术和功能安全性;
(40)“合格评定”是指证明是否满足本法规有关设备的要求的过程;
(41)“合格评定机构”是指执行第三方合格评定活动(包括校准,测试,认证和检查)的机构;
(42)“通知机构”是指根据本法规指定的合格评定机构;
(43)“ CE合格标记”或“ CE标记”是指制造商用来表明设备符合本法规和其他适用的规定其粘贴的联盟协调立法中规定的适用要求的标记;
(44)“临床评估”是指系统的和计划好的过程,用于连续生成,收集,分析和评估与器械有关的临床数据,以验证器械的安全性和性能(包括临床益处),如按预期使用时生产厂家;
(45)“临床调查”是指为评估装置的安全性或性能而进行的涉及一个或多个人类受试者的任何系统调查;
(46)“研究器械”是指经过临床调查评估的器械;
(47)“临床研究计划”是指描述临床研究的基本原理,目标,设计,方法,监测,统计考虑因素,组织和进行的文件;
(48)“临床数据”是指与使用设备有关的安全或性能信息,其来源为:
—有关设备的临床研究,
-可证明该器械与该器械相当的器械的临床研究或科学文献中报告的其他研究,
-在同行评审的科学文献中发表的有关该器械或可证明与该器械等效的器械的其他临床经验的报告,
-来自上市后监督的临床相关信息,尤其是上市后临床随访;
(49)“赞助人”是指负责发起,管理和建立临床研究融资的任何个人,公司,机构或组织;
(50)“受试者”是指参与临床研究的个人;
(51)“临床证据”是指与器械有关的临床数据和临床评估结果,其数量和质量足以使该器械在按以下规定使用时能够安全评估并达到预期的临床益处:生产厂家;
(52)“临床性能”是指由于制造商要求的,由其技术或功能特性(包括诊断特性)引起的任何直接或间接医学效应而导致的设备达到其预期目的的能力。如果按照制造商的意图使用,则可为患者带来临床益处;
(53)“临床受益”是指器械对个人健康的积极影响,以有意义,可测量,与患者相关的临床结果(包括与诊断有关的结果)或对患者管理或公共卫生的积极影响;
(54)“研究者”是指负责在临床研究场所进行临床研究的个人;
(55)“知情同意”是指受试者在被告知与受试者的参与决定有关的临床研究的所有方面之后,自由自愿地表达其参加特定临床研究的意愿。未成年人和无行为能力的人的情况,应由其法定代表代表授权或同意将其纳入临床研究;
(56)“道德委员会”是指根据该会员国的法律在该会员国中建立并有权出于本法规的目的发表意见的独立机构,并考虑到非专业人士(尤其是患者或患者的组织;
(57)“不良事件”是指在临床研究范围内在受试者,使用者或其他人中发生的任何不良医学事件,意外疾病或伤害或任何不良临床症状,包括实验室异常发现,无论是否与研究装置;
(58)“严重不良事件”是指导致以下任何情况的任何不良事件:
(a)死亡,
(b)受试者的健康状况严重恶化,导致以下任何情况:
(i)危及生命的疾病或伤害,
(ii)永久性破坏身体结构或身体功能,
(iii)住院或延长患者住院时间,
(iv)为防止危及生命的疾病或伤害或对身体结构或身体功能的永久损害而进行的医学或外科手术干预,
(v)慢性病,
(c)胎儿窘迫,胎儿死亡或先天性身心障碍或先天缺陷;
(59)“设备不足”是指研究用设备的身份,质量,耐用性,可靠性,安全性或性能方面的任何不足,包括故障,使用错误或制造商提供的信息不足;
(60)“上市后监督”是指制造商与其他经济运营商合作开展的所有活动,以建立并保持系统的程序,以主动收集和审查从他们投放市场的设备中获得的经验,在市场上或投入使用以识别是否需要立即采取任何必要的纠正或预防措施;
(61)“市场监视”是指主管当局为检查和确保设备符合相关的欧盟协调法规所规定的要求而进行的活动和采取的措施,并且不危害健康,安全或任何其他公共利益方面保护;
(62)“召回”是指旨在实现最终用户可以使用的设备退货的任何措施;
(63)“撤回”是指旨在防止供应链中的设备进一步在市场上出售的任何措施;
(64)“事件”是指在市场上出售的设备的任何特性故障或性能下降或性能下降,包括由于人机工程学特性引起的使用错误,以及制造商提供的信息不足和任何不希望的东西。副作用;
(65)“严重事件”是指直接或间接导致,可能导致或可能导致以下任何事件的任何事件:
(a)患者,使用者或其他人的死亡,
(b)患者,使用者或其他人的健康状况暂时或永久严重恶化,
(c)严重的公共卫生威胁;
(66)“严重的公共卫生威胁”是指可能导致死亡的迫在眉睫的危险,某人的健康状况严重恶化或重病的事件,可能需要迅速采取补救措施,并可能导致严重的发病或死亡。人类,或者在给定的时间和地点是不寻常或出乎意料的;
(67)“纠正措施”是指为消除造成潜在或实际不合格或其他不良情况的原因而采取的措施;
(68)“现场安全纠正措施”是指制造商出于技术或医学原因采取的纠正措施,以防止或减少与市场上出售的设备有关的严重事故的风险;
(69)“现场安全通知”是指制造商就现场安全纠正措施向用户或客户发送的通讯;
(70)“统一标准”是指第1025/2012号条例(EU)第2条第(1)(c)项所定义的欧洲标准;
(71)“通用规范”(CS)是指除标准以外的一组技术和/或临床要求,它提供了一种手段来遵守适用于设备,过程或系统的法律义务。
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