MDR-EU-2017-745-欧盟医疗器械法规-第一章

RA小编辑

本文转载自“木之唐咨询”



前言
2020年3月25日欧洲卫生和食品安全委员Stella Kyriakides表示，欧盟委员提议将欧盟医疗器械新版MDR推迟一年实施。欧盟新版MDR原计划于2020年5月26日强制实施。这或许是个好事，又拉长了我们的战线！Anyway，我们将继续按计划研读法规。上周我们分享了MDR法规综述，本周我们将分享第一章范围及定义此次学习重点是Article 2 的71个定义，定义是学习法规的基础。也请各位朋友关注我们，一起读完整部法规。
CHAPTER I SCOPE AND DEFINITIONS
Article 1 主题与范围Subject matter and scope

1

本法规规定了有关欧盟境内供人类使用的医疗器械极其附件的市场投放、市场提供或投入使用方面的规则。本法规也适用于在欧盟进行的有关该医疗器械及其附件临床研究。
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union

2

本法规还应适用于自根据第9条通过的通用规范适用之日起，附录XVI所列并无预期医疗目的产品组，并考虑到基于类似技术的目前最高水平，特别是适用于具有医疗目的类似器械的现有协调标准。该附录XVI中所列产品组的通用规范应至少解决适用于如该产品组附录I中所列风险管理应用，及必要时，针对安全性的临床评价。
应在2020年5月26日通过强制性的通用技术规范。此类规范应自其生效日的六个月后或自2020年5月26日起适用，以最迟发布者为准。This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for an alogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.尽管存在第122条规定，根据第93/42/EEC号指令为附录XVI所涵盖的医疗器械的产品符合相关成员国措施仍应继续有效，直至第一子段所要求的该产品组的相关通用规范适用日为止。Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.本规范也适用在欧盟进行的有关第一子段所述产品的临床研究。This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.

3

具有医疗和非医疗预期目的器械应逐渐的满足适用于具有预期医疗目的器械要求和适用于无预期医疗目的器械的那些要求。Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.______________________（1）2003年2月3日委员会签发的关于医疗器械第93/42/EEC号指令范围内乳房植入物的再分类的委员会第2003/12/EC号指令(OJ L28, 4.2.2003,p. 43)。CommissionDirective 2003/12/EC of 3 February 2003 on the reclassification of breastimplants in the framework of Directive 93/42/EEC concerning medical devices (OJL 28, 4.2.2003, p. 43).（2）2005年8月11日委员会签发的关于医疗器械第93/42/EEC号指令范围髋关节、膝关节和肩关节置换进行重新分类的委员会第2005/50/EC号指令（OJ L210, 12.8.2005,p. 41）。CommissionDirective 2005/50/EC of 11 August 2005 on the reclassification of hip, knee andshoulder joint replacements in the framework of Council Directive 93/42/EECconcerning medical devices (OJ L 210, 12.8.2005, p. 41).（３）2013年9月24日委员会签发的关于根据关于有效可植入医疗器械委员会第90/385/EEC号指令和关于医疗器械第93/42/EEC号指令指定和监督公告机构的委员会第920/2013号实施条例(OJ L253, 25.9.2013,p. 8)。CommissionImplementing Regulation (EU) No 920/2013 of 24 September 2013 on thedesignation and the supervision of notified bodies under Council Directive90/385/EEC on active implantable medical devices and Council Directive93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8).（４）OJ C358,7.12.2013, p. 10.

4

就本法规而言，根据第2段，本法规适用的附录XVI所列医疗器械、医疗器械附录及医疗产品均在下文中简称为“器械”。
For the purposes of this Regulation,medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.

5

如从其特性和风险方面来看，考虑到投放市场的具有医疗目的器械与不具医疗目的产品之间的相似性具有正当理由，则委员会应有权根据第115条借助增加新产品组以通过授权法案从而修订附录XVI中的清单，以便保护使用者或其他人员的健康和安全或所涉及公共卫生的其他方面。
Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated actsin accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health.

6

本法规不适用于：ThisRegulation does not apply to:
（a）欧盟第2017/746号法规所涵盖的体外诊断医疗器械；invitro diagnostic medical devices covered by Regulation (EU) 2017/746;（b）如第2001/83/EC号指令第1条第2点中所定义的医疗产品。在确定产品是否属于第2001/83/EC号指令或本法规的范围时，应特别考虑产品的主要作用模式。medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;（c）欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品；advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;（d）人类血液或血液制品、人源的血浆或血细胞，或者在投放市场或投入使用时，包含此类血液制品、血浆或细胞的器械，但本条第8段所述的器械除外；human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;（e）欧洲委员会第1223/2009号法规所涵盖的美容产品；cosmetic products covered by Regulation (EC) No 1223/2009;（f）动物源的移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但本法规适用于使用非活性或活性动物来源的组织或细胞或其衍生产品制造而成的器械。transplants,tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives,which are non-viable or are rendered non-viable;（g）第2004/23/EC号指令所涵盖的人源移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但器械适用于使用活性或非活性人源组织或细胞的衍生产品制造而成的器械；transplants,tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC,or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells ofhuman origin which are non-viable or are rendered non-viable;（h）除了（d）、（f）和（g）点中述及的那些含有或包括活性生物物质或活菌体（包括活体微生物、细菌、真菌或病毒）以实现或支持产品预期用途的产品；products,other than those referred to in points (d), (f) and (g), that contain orconsist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;（i）第178/2002号（EU）法规所涵盖的食品。food covered by Regulation(EC) No 178/2002.

7

在投放市场或投入使用时，作为欧盟第2017/746号法规第2条第2点所界定的体外诊断医疗器械的一个整体部分任何器械，应受第2017/746号法规管制。本法规的要求应适用于体外诊断医疗器械部件。
Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by thisRegulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.

8

若器械在投放市场或投入使用时，包含某一种必不可少的物质，而该物质若单独使用将被视为第2001/83/EC号指令第1条第2点所界定的医药产品，其中包括该指令第1条第10点所定义的人体血液或血浆来源的药物制品，并且具有辅助器械的作用，该器械应根据本法规进行评估和授权。
但是，若该物质的作用是主要作用，而不是辅助该器械的作用，则综合产品应由适用的欧洲议会和理事会第2001/83/EC号指令或第726/2004号法规（1）管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC,including a medicinal product derived from human blood or human plasma as  defined in point 10 of Article 1 of that Directive, and that has anaction ancillary to that of the device, shall be assessed and authorised inaccordance with this Regulation.However,if the action of that substance is principal and not ancillary to that of thedevice, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (34),as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as thesafety and performance of the device part are concerned.

9

若器械适用于第2001/83/EC号指令第1条第2点定义的药品，则该器械应受本法规管制，且不影响该指令的规定以及欧洲委员会关于药品的第726/2004号法规。
Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.但若该器械预期与药品一起使用，且该药品与器械组成一个整体的方式投放市场，该产品专用于给定的组合并且不可重复使用，则产品应按第2001/83/EC号指令或欧洲委员会第726/2004号法规管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.____________________（1）2004年3月31日欧洲议会和理事关于规定授权和监督人用和兽用医疗产品和成立欧洲药品管理局的共同体程序(OJL136, 30.4.2004, p. 1)。Regulation(EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004laying down Community procedures for the authorisation and supervision ofmedicinal products for human and veterinary use and establishing a EuropeanMedicines Agency (OJ L 136, 30.4.2004, p. 1).

10

当器械在投放市场或投入使用时，包含必不可少的人体非活性组织或细胞或其衍生物，且具有辅助器械的作用，则应按照本法规对该器械进行评估和授权。在这种情况下，第2004/23/EC号指令中规定的捐赠、采购和测试规定应适用。Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an actionancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.但若这些组织或细胞或其衍生物的作用是主要的，而不是辅助器械的作用，且产品不受欧洲委员会第1394/2007号法规管制，则该产品应受第2004/23/EC号指令管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.

11

本法规属于第2014/30/EU号指令第2(3)条所辖欧盟特别立法。
This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.

12

存在指令中所述相关风险的情况下，作为欧洲议会和欧洲委员会关于机械的第2006/42/EC号指令（1）第2段第a点所列器械同样应满足该指令附录I中规定的基本卫生与安全要求，这些要求比本法规附录I第II章所规定的通用安全与性能要求更为具体。
Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (35)shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.

13

本法规不影响第2013/59/Euratom号指令的应用。This Regulation shall not affect the application of Directive 2013/59/Euratom

14

本法规不影响成员国在本法规未涵盖的方面限制使用任何特定类型器械的权利。
This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.

15

本法规不影响有关卫生服务和疗保健的组织、交付或融资的国家法律，例如要求某些器械只能以医疗处方提供，要求只有某些卫生专业人员或卫生护理机构可分发或应用某些器械，或者其应用必须伴随特定的专业咨询。
This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or healthcare institutions may dispense or usecertain devices or that their use be accompanied by specific professional counselling

16

本法规不限制新闻自由或媒体中的言论自由，只要这些自由在欧盟和成员国中得到保障，特别是《欧洲联盟基本权利宪章》第11条。
Nothing in this Regulation shall restrict the freedom of the press or the freedom of expressionin the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.
Article 2 定义Definition就本法规而言，应适用以下定义：For the purposes of this Regulation, the following definitions apply:
   

1

   
“医疗器械”是指由制造商单独使用或组合用于人体的以下一种或多种特定医疗目的任何仪器、设备、器具、软件、植入物、试剂、材料或其他物品：
‘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:对疾病的诊断、预防、监护、预测、预后、治疗或缓解；diagnosis, prevention, monitoring, prediction, prognosis,  treatment or alleviation of disease,对损伤或残疾的诊断、监控、治疗、缓解、补偿diagnosis, monitoring, treatment, alleviation of, or compensation  for, an injury or disability,解剖、生理或病理过程或状态的研究、替代、调节，investigation, replacement or modification of the anatomy or of a  physiological or pathological process or state,通过对来自人体的样本（包括器官、血液、捐献的组织）进行体外检测来提供信息。providing information by means of in vitro examination of  specimens derived from the human body, including organ, blood and tissue  donations,其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；and which does not  achieve its principal intended action by pharmacological, immunological or  metabolic means, in or on the human body, but which may be assisted in its function by such means.
以下产品也应视为医疗器械：The following products shall alsobe deemed to be medical devices:具有控制或支持用途的器械。devices for the control or support of conception;专门用于器械的清洁、消毒或灭菌，如第1（4）条和本点第一子段第中所述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.__________________________（1）2006年5月17日欧洲议会和理事会签发的关于机械和修订第95/16/EC号指令的第2006/42/EC号指令(OJ L157, 9.6.2006,p. 24)。Directive2006/42/EC of the European Parliament and of the Council of 17 May 2006 onmachinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24)   

2

    “医疗器械附件”是指制造商计划将其与一个或几个特定医疗器械一起使用，使该医疗器械可按照其预期用途进行使用，或特定或直接辅助医疗器械来实现其预期用途的功能，但其不是医疗器械的物件；‘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 inaccordance with its/their intended purposes(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)   

3

    “定制器械”是指根据国家法律授权的任何人员的书面处方，通过该人员的专业资格知识而专门制造的器械，具有特有的设计特性，计划专用于特定患者，并专门满足个人条件和需要。‘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 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 activedevice and the patient, without any significant change, shall not be deemed tobe 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’ meansany device which, in whole or in part, penetrates inside the body, eitherthrough 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 acommonality of technology allowing them to be classified in a generic mannernot 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 andis 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 acombination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;   

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 acombination 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。‘instructionsfor 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 charactersthat is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific deviceson 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1nm-100 nm之间。nanomaterial’ means anatural, incidental or manufactured material containing particles in an unboundstate or as an aggregate or as an agglomerate and where, for 50 % or moreof 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 aminute 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 acollection 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 aparticle 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 intended purpose as stated by the manufacturer;   

23

    “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integrateand/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 anduse the information that has been exchanged for the correct execution of aspecified 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

    “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；‘placingon the market’ means the first making available of a device, other than an investigational device, on the Union market   

29

    “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 deviceor 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 in to conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;   

32

    “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 adevice 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, upuntil 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 amanufacturer, an authorised representative, an importer, a distributor or theperson referred to in Article 22(1) and 22(3);
   

36

    “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 or ganisation the primary purpose of which is the care or treatment of patients or the promotion of public health;   

37

    “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;   

38

    “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；‘layperson’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;   

39

    “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 wellas testing and restoring the technical and functional safety of the used device;   

40

    “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;   

41

    “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

    “公告机构”是指根据本法规指定的符合性评估机构；notifiedbody’ means a conformity assessment body designated in accordance with this Regulation   

43

    “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 setout 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 thedevice 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 assess the safety or performance of a device;   

46

    “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;   

47

    “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) of the device concerned,clinical investigation(s) or other studies reported in scientific literature, of adevice 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 questioncan be demonstrated,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;   

49

    “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

    “受试者”是指参与临床研究的个体；‘subject’ means an individual who participates in a clinical investigation;   

51

    “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；‘clinicale vidence’ means clinical data and clinical evaluation results pertaining to adevice 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 onpatient management or public health.   

54

    “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;
   

55

   
“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 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 inaccordance 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 orany untoward clinical signs, including an abnormal laboratory finding, insubjects, users or other persons, in the context of a clinical investigation,whether or not related to the investigational device;   

58

    “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:（a）死亡death,，（b）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 thefollowing:：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,住院或延长患者的住院时间；hospitalisation or prolongation of patient hospitalisation,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，medicalor surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,慢性疾病，chronic disease,（c）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 acongenital physical or mental impairment or birth defect;   

59

    “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 them an ufacturer   

600

    “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 carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements setout in the relevant Union harmonisation legislation and do not endanger health,safety or any other aspect of public interest protection;   

62

    “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;   

63

    “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;
   

64

    “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；thedeath 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 otherperson'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 ofdeath, 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 placeand 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 actualnon-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 safetynotice’ means a communication sent by a manufacturer to users orcustomers 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;   

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    “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 adevice, process or system.
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 inpoint (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.
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 dulysubstantiated 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 whetheror 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.