MDR EU - 2017 - 745 欧盟医疗器械最新法规（中英对照版） - 图

欧盟官方公报

L117

第60卷

中文版 内容

I 立法法案

法规

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立法

2017年5月5日

欧洲议会和理事会于2017年4月5日签发的关于医疗器械第2017/745号法规，修订了第2001/83/EC号指令，第178/2002号（EU）法规和第1223/2009号（EU）法规，并废除了理事会第90/385/EEC号和第93/42/EEC号指令（1）························································1

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欧洲议会和理事会于2017年4月5日签发的关于体外诊断医疗器械第2017/746号（EU）法规并废除了第98/79/EC号指令和理事会第2010/227/EU号决议······················································176

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（1）EEA相关性文本。

以浅色字体打印标题的法案均为涉及农业日常管理的法案，一般在有限期内有效。 所有其他法案的标题均以粗体打印，并以星号开头。

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I

（立法法案） 法规

欧洲议会和理事会于2017年4月5日签发的关于医疗器械第2017/745号法规，修订了第2001/83/EC号指令，第178/2002号（EU）法规和第1223/2009号（EU）法规，并废除了理事会第90/385/EEC号和第93/42/EEC号指令 （EEA相关性文本）

欧洲议会和欧盟委员会，

考虑到“欧盟运作条约”，特别是其中第114条和第168（4）（c）条规定， 并考虑到欧盟委员会提案， 于立法草案转交各国议会后，

考虑到欧洲经济和社会委员会之意见（1）， 在咨询地区委员之后， 根据一般立法程序运作（2）， 鉴于： (1)

理事会第90/385/EEC号指令（3）和理事会第93/42/EEC号指令（4）构成有关医疗器械（不包括体外诊断医疗器械）的欧盟监管框架。但需要对该指令进行大幅修订，以便建立稳健、透明、可预测和可持续的医疗器械监管框架，以确保高水平的安全和健康，同时为创新提供支持。

Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory

framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable

regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. (2)

本法规旨在确保区域内医疗器械市场的平稳运作，在为患者和使用者提供高水平健康保护的基础上，同时考虑到活跃于本行业的中小型企业利益。同时，本法规为医疗器械的质量及安全性制定了较高标准，以满足器械产品常见安全问题的管控。这两个目标相辅相成、不可分割地联系在一起，并且在达成过程中没有主次顺序。关于欧盟运作条约（TFEU）第114条，本法规融合了上市销售以及将医疗器械及其附件投入欧盟市场的规则，这些规则可能受益于货物自由流通原则。针对TFEU第168(4)(c)条，本法规通过确保临床研究的数据的可靠性和稳健性，来保障这些器械的质量及安全，并保障参与临床研究受试者的安全。

This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and

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safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.

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（1）2013年2月14日意见（OJ C 133, 9.5.2013, p. 52）。

（2）2014年4月2日的欧洲议会立场（尚未在官方公告内公布）以及2017年3月7日首次审阅时理事会的立场（尚未在官方公告内公

布）。

（3）1990年6月20日签发的关于成员国有关可植入医疗器械法律的理事会第90/38/EEC号指令（OJ L 331, 7.12.1998, p.1）。 （4）1993年6月14日签发的关于医疗器械的理事会第93/42 EEC号指令（OJ L 169，12.7.1993，p. 1）。

（3） 本法规并不寻求协调有关医疗器械投入使用后，在市场上进一步供应之规则，例如二手销售。

This Regulation does not seek to harmonise rules relating to the further making available on the market of medical

devices after they have already been put into service such as in the context of second-hand sales.

（4） 应大大加强现有监管方法的关键要素，例如公告机构监管、符合性评估流程、临床研究和临床评价，警戒和市

场监管，同时引入确保医疗器械透明度和可追溯性之规定，以改善健康和安全性。

Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.

（5） 如有可能，应当考虑到为医疗器械制定的国际指导准则，特别是全球协调工作队及其后续行动即“国际医疗器

械监管机构论坛（IMDRF）”，以便推动世界范围内利于提高安全防护标准以及促进贸易之相关法规的全球化进程，特别是关于唯一器械标识、通用安全与性能要求、技术文件、分类标准、符合性评估流程和临床证据等方面的规定。

To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations.

（6） 出于历史原因，第90/385/EEC号指令所涵盖的有源植入式医疗器械以及第93/42/EEC号指令所涵盖的其他医疗

器械通过另外两个单独的法律进行管控。为简化起见，经过若干次修订的两项指令均应替换为适用于除体外诊断医疗器械外所有医疗器械的单一立法法案。

For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other

medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices. (7)

本法规的适用范围应与其他相关产品的欧盟协调立法明确区分开，（如体外诊断医疗器械、医药产品、美容产品和食品）。因此，应对欧洲议会和委员会第178/2002号法规（1）进行修订，将医疗器械排除在其范围之外。 The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (5) should be amended to exclude medical devices from its scope. (8)

成员国有责任逐案例确认，各产品是否属于本法规范围。为确保所有成员国的相关判断力一致，特别是在灰区临界情况下，在咨询医疗器械协调小组（MDCG）后，应允许委员会主动或经成员国适时且有根据地请求，逐案决定某一具体产品、类别或产品组是否属于本法规适用范围。在审议涉及药品、人体组织和细胞、生物灭活

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产品或食品之临界案例所辖产品之监管状况时，委员会应确保欧洲药品管理局、欧洲化学品管理局和欧洲食品安全局的适当咨询水平。

It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells,

biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant. (9)

由于在某些情况下医疗器械和美容产品难以区分，因此欧盟议会和理事会第1223/2009号法规（2）中也应加入对某一产品法规状况的欧盟范围统一决议。

Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of taking a Union-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (6).

（10） 药械组合类产品将按照本法规或欧洲议会和理事会第2001/83/EC号指令（3）进行管理。在涉及该药械组合产

品的监管活动中，在上市前评估咨询及信息交换期间，两项立法法案应确保适当的相互关联。对于药械组合产品，应当在该医疗产品上市许可背景下，充分评估其是否符合本法规中规定的通用安全与性能要求。因此，应修订第2001/83/EC号指令。

Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (7) The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should therefore be amended.

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（1）欧洲议会和理事会于2002年1月28日签发的第178/2002号（EC）法规规定了食品法的一般原则和要求，设立了欧洲食品安全局

并制定了食品安全方面的程序（OJ L 31，1.2.2002，p.1）。

（2）欧洲议会和理事会于2009年11月30日签发的关于美容产品的第1223/2009号（EC）法规（OJ L 342，22.12.2009，p.59）。 （3）欧洲议会和理事会于2001年11月6日签发的关于人类药用产品社区规则的第2001/83/EC号指令（OJ L 311,28.11.2001，p.67）。

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（11） 对于非活性或处理为非活性的人类来源组织或细胞衍生物制造的特定产品，欧盟立法特别是欧盟议会和理事会

第1394/2007号法规（1）和第2004/23/EC号指令（2）并不完善。此类产品应属于本法规管辖范围，但前提是其应符合医疗器械的定义或受本法规管辖。

Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (8) and Directive 2004/23/EC of the European Parliament and of the Council (9), is incomplete in respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. Such products should come under the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Regulation.

（12）本法规应涵盖制造商声称仅具有美容目的或另一种非医疗目的，但在功能和风险特征方面类似于医疗器械的特

定产品组。为能使制造商证明此类产品的符合性，委员会应至少在应用风险管理时采用通用技术规范，并在必要时对安全性进行临床评价。这些通用技术规范应针对无医疗目的产品组制定，且不得用于具有医疗目的之类似器械的符合性评估。具有医疗和非医疗预期目的之器械应当同时满足具有和不具有预期医疗目的之器械相关要求。

Certain groups of products for which a manufacturer claims only an aesthetic or another non-medical

purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety. Such common specifications should be developed specifically for a group of products without an intended medical purpose and should not be used for

conformity assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical intended purpose should fulfil both the requirements applicable to devices with, and to devices without, an intended medical purpose.

（13） 由于第90/385/EEC和93/42/EEC号指令和本法规中明确排除含有人类或动物来源活组织或细胞的产品，应当澄

清的是，含有或构成自其他来源活体生物物质或活体组织以实现或支持这些产品预期目的之产品也不在本法规管辖范围内。

As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly

excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain or consist of viable biological materials or viable organisms of another origin in order to achieve or support the intended purpose of those products are not covered by this Regulation either.

（14） 欧洲议会和理事会第2002/98/EC号指令（3）设定的要求应当继续适用。

The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (10) should continue to apply.

（15） 适用于器械的纳米材料风险和益处目前存在科学不确定性。为确保高水平的健康保护、货物自由流通和制造商

的法律确定性，基于委员会第2011/696/EU号建议（4），有必要为纳米材料引入一个统一定义，这一定义应具有必要的灵活性，以使得这一定义适应科学和技术进展以及后续欧盟和国际层面的监管发展。在器械的设计和制造中，制造商在使用具有较高或中等体内照射可能的纳米颗粒时应特别注意，这些器械应接受最为严格的符合性评估程序。在法案试行期间对本法规中规定的相关要求的实施以及应用，应考虑相应科学委员会的科学意见。

There is scientific uncertainty about the risks and benefits of nanomaterials used for devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission

Recommendation 2011/696/EU (11), with the necessary flexibility to adapt that definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of devices, manufacturers should take special care when using nanoparticles for which there is a

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high or medium potential for internal exposure. Such devices should be subject to the most stringent

conformity assessment procedures. In preparation of implementing acts regulating the practical and uniform application of the corresponding requirements laid down in this Regulation, the relevant scientific opinions of the relevant scientific committees should be taken into account.

（16）欧洲议会和理事会第2014/30/EU号指令（5）所论述的安全问题属于本法规中规定的器械通用安全与性能要求

的一部分。因此，本法规应被视为与该指令有关的特别法。

Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (12) are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a lex specialis in relation to that Directive.

（17）本法规应包括关于发射离子辐射的器械的设计和制造要求，而不影响寻求其他目标的理事会第2013/59/Euratom

号指令（6）的适用性。

This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom (13) which pursues other objectives.

（18）本法规应包括关于旨在防止职业伤害（包括辐射防护）的器械设计、安全与性能特性相关要求。

This Regulation should include requirements for devices' design, safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation.

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（1）欧洲议会和理事会于2007年11月13日签发的关于前沿疗法医药产品的第1394/2007号（EC）法规和修订了第2001/83/EC号指令和

第726/2004号（EC）法规（OJ L 324,10.12.2007，p. 121）。 2

（）欧洲议会和理事会于2004年3月31日签发的关于制定人体组织和细胞捐赠、采购、检测、处理、保存、储存和分配质量和安全标准

的第2004/23/EC号指令（OJ L 102，7.4.2004，p. 48）。 3

（）欧洲议会和理事会于2003年1月27日签发的关于制定了人血和血液成分的收集、测试、处理、储存和分配的质量和安全标准的第

2002/98/EC号指令（OJ L 33，8.2.2003，p. 30）。 4

（）2011年10月18日签发的关于纳米材料定义的委员会第2011/696/EU号建议（OJ L 275,20.10.2011，p. 38）。 5

（） 2014年2月26日欧洲议会和理事会第2014/30/EU号指令关于成员国有关电磁兼容性(OJ L 96, 29.3.2014. p. 79)。

（6） 2013年12月5日签发的理事会第2013/59/Euratom号指令规定了有关因离子辐射接触所引起的危险防护的基本安全标准，并废除寻

求其他目标的第89/618/Euratom号指令、第90/641/Euratom号指令、第96/29/Euratom号指令、第97/43/Euratom号指令和第2003/122/Euratom号指令(OJ L 3, 17.1.2014, p. 1)。

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（19） 有必要明确的是，当制造商的软件专用于医疗器械定义中所述的一种或多种医学目的时，软件本身可视为医疗

器械，而用于一般目的的软件，即使在医疗保健环境中使用，或用于健康应用之软件，均不视为医疗器械。作为器械或附件之软件的资格评定不得依赖于这个软件和器械之间的物理位置或互连类型决定。

It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.

（20） 本法规中，关于器械本身、器械供应、经济运营商、使用者和具体过程、符合性评估、临床研究与证据、上市

后监管、警戒和市场监管、标准和其他技术规范等定义应当符合欧盟和国际上本领域的既定做法，以提高法律确定性。

The definitions in this Regulation, regarding devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical investigations and clinical evaluations, post-market surveillance, vigilance and market surveillance, standards and other technical

specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty.

(21)

应明确指出，通过欧洲议会和理事会第2015/1535号指令（1）中所规定的信息服务，向欧盟人员提供的器械以及在商业活动范围内用于为欧盟内人员提供诊断或治疗服务的器械，当在欧盟境内上市或提供服务时，必须符合本法规要求。

It should be made clear that it is essential that devices offered to persons in the Union by means of

information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (14) and devices used in the context of a commercial activity to provide a diagnostic or

therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

（22） 为认识到标准化在医疗器械领域中的重要作用，符合欧洲议会和理事会第1025/2012号法规（2）中规定的协调

标准之相关证据，应是制造商证明其产品符合通用安全与性能要求以及其他法律要求（如本法规所述质量和风险管理）的手段。

To recognise the important role of standardisation in the field of medical devices, compliance with

harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (15) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation. (23)

欧洲议会和理事会第98/79/EC号指令（3）允许委员会对特定类别体外诊断医疗器械采用通用技术规范。在没有协调标准或协调标准不充分的地区，委员会应有权制定通用规范，以提供一种手段来符合本法规规定之通用安全与性能要求，以及临床研究和临床评估及/或上市后跟踪等要求。

Directive 98/79/EC of the European Parliament and of the Council (16) allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance

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requirements, and the requirements for clinical investigations and clinical evaluation and/or post-market clinical follow-up, laid down in this Regulation.

（24） 在咨询相关利益相关者并考虑欧洲和国际标准后，应制定通用规范（“CS”）。

Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking

account of European and international standards.

（25） 适用于器械的规则应酌情与“产品营销新立法框架”保持一致，其中包括欧洲议会和理事会第765/2008号法规

（4），和欧洲议会和理事会第768/2008/EC号决议（5）。

The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council (17) and Decision No 768/2008/EC of the European Parliament and of the Council (18).

（26） 针对进入欧盟市场的产品，欧洲委员会第765/2008号法规规定的欧盟市场监管和控制规则，同样适用于本法规

所涵盖的器械，但这不妨碍成员国自行选择主管机构来执行这些任务。

The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks.

（27） 根据“产品营销新立法框架”，在不影响本法规不同部分规定的具体义务的情况下，明确规定不同经济运营商（包

括进口商和经销商）的一般义务，加强对本法规要求的理解，从而提高相关运营商的法规符合性。

It is appropriate to set out clearly the general obligations of the different economic operators, including

importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance

understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators. _____________________

（1）欧洲议会和理事会于2012年10月25日签发的有关欧洲标准化的第1025/2012号指令，修订了欧洲理事会第89/686/EEC和93/15/EEC号指令以及欧洲

议会和理事会第94/9/EC、94/25/EC、95/16/EC、97/23/EC、98/34/EC、2004/22/EC、2007/23/EC、2009/23/EC和2009/105/EC号指令，并废除了欧洲理事会第87/95/EEC号决议和欧洲议会和理事会第1673/2006/EC号决议（OJ L 316, 14.11.2012, p. 12）。

（）欧洲议会和理事会于2012年10月25日签发的有关欧洲标准化的第1025/2012号指令，修订了欧洲理事会第89/686/EEC和93/15/EEC号指令以及欧洲

议会和理事会第94/9/EC、94/25/EC、95/16/EC、97/23/EC、98/34/EC、2004/22/EC、2007/23/EC、2009/23/EC和2009/105/EC号指令，并废除了欧洲理事会第87/95/EEC号决议和欧洲议会和理事会第1673/2006/EC号决议（OJ L 316, 14.11.2012, p. 12）。

（3）欧洲议会和理事会于2015年9月9日签发的关于在信息服务技术标准和法规领域提供信息的流程的第2015/1535号指令（OJ L 241, 17.9.2015, p.1）。 （4）欧洲议会和理事会于2008年7月9日签发的关于与产品营销有关的认证和市场监管的要求的第765/2008号法规，废除了第339/93号法规 (OJ L 218,

13.8.2008,p. 30).

（5）欧洲议会和理事会于2008年7月9日签发的关于产品营销通用框架的第768/2008/EC号决议，并废除理事会第93/465/EEC号决议（OJ L 218, 13.8.2008,

p. 82）。

2

（28） 就本法规而言，经销商的活动应视为包括获取、持有和供应器械。

For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition,

holding and supplying of devices.

（29） 制造商的一些义务，例如临床评价或警戒报告，仅为第90/385/EC和93/42/EEC号指令的附录中列出之内容，

这些应纳入本法规颁布条款中，以便于应用。

Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.

（30） 卫生机构应可内部（而不是在工业规模上）制造、修改和使用器械，从而解决目标患者群体的具体需求，这些

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需求往往无法通过市场上适当性能水平的等效医疗器械来满足。在这种情况下，适当的做法是在本法规中规定特定条款的豁免，这就是关于仅在卫生机构（含医院以及支持卫生保健系统和/或解决患者需求但可能不会直接治疗或照顾患者之实验室和公共卫生机构等）内部制造和使用器械的豁免条例，这样本法规就可以适当方式予以满足。应注意，卫生机构的概念不包括主要追求健康利益或健康生活方式的机构，例如健身房、水疗中心、健康与健身中心。因此，适用于卫生机构的豁免条例不适用于这些机构。

Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market. In that context, it is appropriate to provide that certain rules of this Regulation, as regards medical devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the healthcare system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a

proportionate manner. It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption applicable to health institutions does not apply to such establishments.

（31） 鉴于自然人或法人可根据适用欧盟和国家法律，就缺陷器械造成的损害提出索赔，因此，可要求制造商采取适

当措施，就其在第85/374/EEC号指令（1）规定的潜在责任提供足够的保险范围。这些措施应与器械的风险等级、类型和企业规模成比例。在本文中，还应规定有关主管机构向可能因缺陷器械而受伤人员提供信息的规则。 In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC (19). Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device.

（32） 为确保批量生产的器械继续符合本法规的要求，并且将生产的器械的使用经验纳入生产过程中，所有制造商均

应具备质量管理体系和上市后监管体系，此类系统应与上述器械的风险级别和分类对应。此外，为尽可能降低器械相关的风险或防止与之相关事故的发生，制造商应建立风险管理体系，以及报告事故和现场安全纠正措施的系统。

To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.

（33） 风险管理体系应与器械的临床评估过程保持一致，并在该评估过程中反映，包括作为临床研究、临床评估和上

市后临床跟踪的一部分需解决的临床风险。风险管理和临床评估过程应相互依存，并应定期更新。

The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated.

（34） 应确保由符合最低资格条件的负责法规符合性的人员在制造商组织内进行医疗器械制造的监督和控制以及上

市后监管和警戒活动。

It should be ensured that supervision and control of the manufacture of devices, and the post-market

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surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.

(35)

对于欧盟以外的制造商，授权代表在确保此类制造商生产的器械符合性，以及作为其在欧盟建立的联系人方面发挥关键作用。鉴于这种关键作用，若欧盟以外的制造商未遵守其一般义务，出于执法目的，其授权代表依然应当对有缺陷的器械负法律责任。本法规规定的授权代表的法律责任并不影响第85/374/EEC号指令的规定，因此授权代表应对进口商和制造商承担连带责任。应在书面指令中确定授权代表的职责。鉴于授权代表的角色，应明确规定其应满足的最低要求，包括提供满足最低资格条件的人员的要求，此类资格条件应与制造商处负责法规符合性的人员的资格条件类似。

For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.

_________________________

（1） 欧盟委员会于1985年7月25日签发的关于其在涉及缺陷产品责任的成员国相似法律、法规和管理规定的第85/374/EEC号指令

(OJL210, 7.8.1985, p. 29)。

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(36) 为确保经济运营商义务的法律确定性，有必要说明何时将经销商、进口商或其他人视为器械制造商。 To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device.

(37) 根据“欧盟运作条约（TFEU）”第34条的规定，（该规定以TFEU第36条规定的健康和安全保护需求以及知识产权保护需求带来的限制性规定为准）已经投放市场的产品的平行贸易是内部市场的一种合法贸易形式。但这一平行贸易原则的适用性受成员国的不同解释的制约。因此，应在本法规中特别规定重贴标和重包装的要求，同时考虑到其他相关行业的法院案例法（1）和医疗器械领域的现有良好实践。

Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice (20) in other relevant sectors and existing good practice in the field of medical devices.

(38)

一次性使用器械的再加工和进一步使用仅可在国家法律允许的情况下以及遵守本法规中规定的相关要求下进行。一次性使用器械的再加工者应视为再加工器械的制造商，并应承担本法规规定的制造商义不容辞的义务。尽管有上述规定，成员国有责任决议卫生机构内或通过代表该机构的外部再加工者对一次性使用器械再加工和再利用的义务可能与本法规中所述的制造商义务不同。原则上，仅当在机构内或通过代表该机构的外部再加工者对一次性器械再加工和重新利用符合已通过的CS，或在缺乏CS时，符合相关协调标准和国家法规，才允许该偏差的存在。再加工此类器械应确保与相应未使用的一次性器械相同的安全和性能水平。

The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation. The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the

obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use devices within a health institution or by an external reprocessor acting on its behalf may differ from the obligations on a manufacturer described in this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of single-use devices within a health institution or by an external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS, with relevant harmonised

standards and national provisions. The reprocessing of such devices should ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.

（39） 应给予植入器械患者以明确且容易获得的，足够识别所植入器械的基本信息，以及关于该器械的其他信息，包

括任何必要的健康风险警戒或需采取的预防措施，例如关于其是否与某些诊断器械或用于安全控制的扫描仪兼容的指示。

Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.

（40） 一般来说，器械应具有CE标识，表明其符合本法规，以便其在欧盟内自由流通并根据其预期目的投入使用。成

员国不得对符合本法规规定要求的器械，在其投放市场或投入使用方面制造障碍。不过，应允许成员国决定是否限制使用本法规未涵盖的任何特定类型的器械。

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Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.

（41） 由于改进的事故报告、有针对性的现场安全纠正措施以及主管机构更好的监督机制，通过基于国际指导的唯一

器械标识系统（UDI系统）实现的器械的可追踪性，应显著提高器械上市后安全相关活动的有效性。这归功于减少的医疗失误，以及对虚假器械的打击。UDI系统的应用还应改善卫生机构和其他经济运营商的采购和废物处置政策以及库存管理，并在可能的情况下，与这些设置中存在的其他验证系统兼容。

The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related

activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.

（42） UDI系统应适用于除定制器械以外的投放于市场的所有器械，并基于国际公认的原则，包括与主要贸易伙伴相

一致的定义。为使UDI系统及时起作用，以免影响本法规生效，应在本法规中做出详细规定。

The UDI system should apply to all devices placed on the market except custom-made devices, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation.

（43） 为保护公众健康，赋予患者和医疗保健专业人员自主权以及确保其能够做出明智的决定，为向监管决定制定提

供一个稳妥的基础，确保为预期使用者提供的信息的透明度和充分性对于公众利益至关重要。

Transparency and adequate access to information, appropriately presented for the intended user, are

essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.

________________________

（1）2011年7月28日法院对Orifarm和Paranova中案件：C-400/09和C-207/10, ECLI:EU:C:2011:519的判决

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（44） 为达成本法规目标，其中一个关键点是建立欧洲医疗器械数据库（Eudamed），该数据库应整合不同的电子系统，

以核对和处理关于上市的体外诊断医疗器械以及相关经济运营商、符合性评定问题、公告机构、证书、临床研究、警戒和后市场监管等相关信息。数据库的目标是提高总体透明度，包括通过更好地为公众和卫生保健专业人员提供信息，以避免多重报告要求、加强成员国之间的配合、简化和促进经济运营商、公告机构或申办方和成员国之间的信息流通，以及成员国之间和欧盟委员会之间的信息流通。在内部市场中，只能在欧盟级别有效

确保这一点，因此欧盟委员会应进一步开发和管理委员会第2010/227/EU号决议（1）设置的医疗器械数据库。

One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU (21).

（45） 为促进欧洲医疗器械数据库（Eudamed）的运作，国际公认的医疗器械命名应免费提供给制造商和其他自然人

或法人，且本法规要求相关人员必须使用该命名。此外，在合理可行的情况下，也应向其他利益相关者免费提

供此类命名。

To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.

（46） Eudamed关于市场上的器械，相关经济运营商和证书的电子系统应确保公众充分了解欧盟市场上的器械。临床

研究电子系统应作为工具，确保成员国之间合作，以及申办方能够在自愿基础上向若干成员国提交单项申请，并报告严重不良事件、器械缺陷和相关更新。电子警戒系统应确保制造商能够报告严重事件和其他异常事件，并支持主管机构协调此等事故和事件的评估。市场监管相关电子系统应作为主管机构之间进行信息交流的工

具。

Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical investigations should serve as a tool for the cooperation between

Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.

（47） 关于通过Eudamed电子系统核对和处理的数据，欧洲议会和理事会第95/46/EC号指令（2）适用于在成员国主

管机构（特别是成员国指定的公共独立机构）的监督下，由成员国进行个人数据处理。欧洲议会和理事会第45/2001号法规（3）适用于在欧洲数据保护管理程序的监督下，由委员会在本法规框架内处理个人数据。根据第45/2001号指令，应指定委员会作为Eudamed及其电子系统的管理者。

In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (22) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (23) applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In

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accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.

（48） 对于可植入器械和III类器械，制造商应在公开提供的文件中总结器械的主要安全与性能方面以及临床评估的结果。

For implantable devices and for class III devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.

（49） 器械安全和临床性能总结应特别包括在诊断或治疗选择中器械的地位，并考虑到在与诊断或治疗替代项相比时

的器械临床评价，以及可能考虑该器械及其备选方案的具体条件。

The summary of safety and clinical performance for a device should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.

（50） 公告机构的正常运作对于确保高水平的健康和安全保护以及公民对系统的信心至关重要。因此，成员国根据详细和严格的标准对指定机构进行的指定和监测，应在欧盟级别实行控制。

The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and

citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.

（51） 公告机构对制造商的技术文件的评估，特别是其临床评估文件，应由负责公告机构的主管机构进行严格评估。此类评估是一种基于风险的手段，用于监督和监测公告机构活动，评估时可采取相关文件抽样的方法。 Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation.

（52） 应加强公告机构对制造商的监管，包括其进行突击飞行检查和对器械进行物理或实验室测试的权利和义务，以

确保制造商在收到原始证书后持续合规。

The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.

________________________

（1） 委员会签发的关于设立医疗器械数据库的委员会第2010/227/EU号决议

（2）欧洲议会和理事会于1995年10月24日签发的关于保护个人在处理个人数据和数据自由流通方面的第95/46/EC22号指令(OJ L281,

23.11.1995, p. 31)。

（3）欧洲议会和理事会于2000年12月18日签发的关于保护个人在欧共体机构和机构处理个人数据方面的欧洲理事会第45/2001号指令

24(OJ L8, 12.1.2001, p. 1)。

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（53） 为提高国家主管机构监督公告机构的透明度，公告机构的主管机构应公布其用于指定和监测器械公告机构的国家评估监管措施的信息。根据良好的行政实践，主管机构应该及时更新这些信息，特别是反映上述流程的相关、重大或实质性变更。

To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the

assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question.

（54） 公告机构所在的成员国应负责执行本法规关于该公告机构的要求。

The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.

（55） 特别是考虑到成员国组织并提供保健服务和医疗护理的责任，允许其制定有关公告机构的其他要求，此类机构用于器械的符合性评估，并且基于本法规未规定问题的领域。规定的此等额外要求不会影响欧盟针对公告机构更为具体的横向欧盟立法和对公告机构的平等对待。

In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies.

（56） 对于旨在施用和/或去除某种医疗产品的III类可植入器械和IIb类有源器械，公告机构应有责任要求专家小组仔细审查其临床评估的评定报告（某些特定情况除外）。并且应当于这一专家小组符合性评估程序之后获得证书的器械通知主管机构。通过分享临床方面的专业知识以及按已完成此咨询程序的器械分类建立CS，临床评估相关专家小组的咨询结果应得出高风险医疗器械的协调评估。

For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed about

devices that have been granted a certificate following a conformity assessment procedure involving an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.

（57） 对于III类和特定IIb类器械，制造商应在其临床评估和/或调查之前，可自愿就其临床开发策略和临床研究提案咨询专家小组。

For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.

（58） 有必要根据国际惯例将器械划分为四个产品类别，特别是出于符合性评估流程考虑。基于人体脆弱性并考虑到与器械技术设计和制造相关的潜在风险的分类规则。为保持与第90/385/EEC号指令中所规定相同的安全水平，有源植入式器械应属于最高风险类别。

It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the

division of devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. To maintain the same level of safety as provided by

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Directive 90/385/EEC, active implantable devices should be in the highest risk class.

（59）

旧框架下适用于侵入性器械的规则并未充分考虑到引入人体的特定器械侵入性水平和潜在毒性。针对在人体中吸收或局部扩展的物质或物质组合构成的器械，为获得基于风险的适当分类，必须针对此等器械引入特定分类规则。分类规则应当考虑到该器械在人体内或在人体上发挥作用的位置及将其引入或加以应用的位置，以及组成器械的这些物质还是这些物质在人体中的代谢产物是否会发生全身吸收。

Rules under the old regime applied to invasive devices do not sufficiently take account of the level of

invasiveness and potential toxicity of certain devices which are introduced into the human body. In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices. The classification rules should take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances of which the device is composed, or of the products of metabolism in the human body of those substances occurs.

（60）

考虑到与这些器械有关的低水平脆弱性，作为一般规则，应由制造商单独负责执行有关I类器械的符合性评估程序。对于IIa、IIb和III类医疗器械，应当强制公告机构进行适当程度的参与。

The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.

（61）

应进一步加强和简化器械符合性评估流程，同时应明确规定公告机构对其评估执行情况的要求，以确保公平竞争的环境。

The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.

(62)

自由销售证书包含的信息，应该有助于使用Eudamed，以便获得器械的信息，无论器械是否上市，从市场撤出或召回，以及具备何种合格证。

It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.

（63）

为确保具有较高的安全与性能水平，本法规中规定的通用安全与性能要求符合性的证明应基于以下临床数据：作为一般规则，对于III类器械和可植入性器械，此类数据应来自申办方所进行的临床研究。还可以由制造商和另一自然人或法人作为申办方负责开展此类临床研究。

To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical data that, for

class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor. It should be possible both for the

manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical investigation.

（64） 临床研究的规则应符合该领域成熟的指导原则，例如关于人类受试者医疗器械临床研究的临床试验质量管理

规范（ISO国际标准14155:2011），以促使将在欧盟内进行的临床研究结果成为欧盟境外得到认可的文件规范，并促使根据国际准则在欧盟之外进行的临床研究结果可在欧盟内获得认可。此外，这些规则应符合世界医学协会《赫尔辛基宣言》关于涉及人类受试者医学研究伦理原则的最新版本。

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The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.

（65） 应由开展临床研究的成员国决定参与评估申请进行临床研究的适当管理机构，并组织伦理委员会在本法规设

定的临床研究授权的时间期限内参与。这些决定属于各成员国的内部组织问题。在这种情况下，成员国应确保非专业人员，特别是患者或患者组织的参与。此外，其还应确保提供必要的专门知识。

It should be left to the Member State where a clinical investigation is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a clinical investigation and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical investigation as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available.

（66） 若在临床研究过程中，对受试者造成的伤害导致研究者或申办方承担民事或刑事责任，在这种情况下的法律

责任条件，包括问题的因果关系和损害赔偿和制裁的水平，应该接受国家法律管辖。

Where, in the course of a clinical investigation, harm caused to a subject leads to the civil or criminal liability of the

investigator or the sponsor being invoked, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.

（67） 应在欧盟层面建立一个电子系统，以确保在可公开访问的数据库中记录和报告每一项临床研究。为保护“欧

盟基本权利宪章”第8条规定的个人资料保护权益，不得在电子系统中记录参与临床研究的受试者的个人资料。为确保与医药产品临床试验领域的协同作用，临床研究的电子系统应与人用药品临床试验的欧洲数据库互通。An electronic system should be set up at Union level to ensure that every clinical investigation is recorded and reported in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.

（68） 如需在一个以上的成员国进行临床研究，则申办方应提交单独申请，以便减少行政负担。为允许资源共享并

确保用于研究器械以及临床研究的科学设计的卫生安全方面的一致性，这种单项申请的评估流程应便于在协调成员国指导下成员国之间协调。此等协调评估不得包括对临床研究的国家、地域和族群方面的评估，包括知情同意。自本法规施行之日起七年内，成员国应自愿参与协调评估。在这一时期结束后，所有成员国都有义务参与协调评估。委员会根据成员国之间自愿协调所取得的经验，应拟订有关协调评估流程的相关规定应用报告。若报告的结果是否定的，委员会应提交一份建议，延长协调评估流程中自愿参与的时间段。Where a clinical investigation is to be conducted in more than one Member State, the sponsor should have the

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possibility of submitting a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the investigational device and of the scientific design of that clinical investigation, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State. Such coordinated assessment should not include the

assessment of intrinsically national, local and ethical aspects of a clinical investigation, including informed consent. For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment. The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure.

（69） 申办方应向开展临床研究的成员国报告在临床研究期间发生的特定不良事件和器械缺陷。如认为有必要确保

参与临床研究的受试者得到高水平保护，成员国应可以终止或暂停此等研究或撤销此等研究的授权。这些信息应该传达给其他成员国。Sponsors should report certain adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted. Member States should have the possibility of terminating or suspending the investigations or revoking the authorisation for those investigations, if considered necessary to ensure a high level of protection of the subjects participating in a clinical investigation. Such information should be communicated to the other Member States.

（70） 如适用，临床研究的申办人应在本法规规定的时间期限内编制一份预期使用者容易理解的临床研究研究摘要，

连同临床研究报告一起提交。如因科学原因未能在规定的时间内提交结果摘要，申办人应说明理由，并说明何时提交结果。The sponsor of a clinical investigation should submit a summary of results of the clinical investigation that is easily understandable for the intended user together with the clinical investigation report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted.

（71） 本法规应涵盖旨在证明器械符合性，以收集临床证据为目的的临床研究，并应同时规定有关其他类型医疗器

械临床研究的伦理和科学评估的基本要求。This Regulation should cover clinical investigations intended to gather clinical evidence for the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and scientific assessments for other types of clinical investigations of medical devices.

（72） 无行为能力受试者、未成年人、孕妇和哺乳期妇女需要特殊保护措施。但需要由成员国确定无行为能力受试

者和未成年人的法定代表人 ncapacitated subjects, minors, pregnant women and breastfeeding women

require specific protection measures. However, it should be left to Member States to determine the legally designated representatives of incapacitated subjects and minors.

（73） 应遵守欧洲议会和理事会第2010/63/EU号指令（1）中所规定的动物实验领域的替换、减少和完善原则。特

别是，应避免不必要的重复测试和研究。The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and of the Council (24) should be observed. In particular, the unnecessary duplication of tests and studies should be avoided.

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（74） 制造商应在售后阶段发挥积极作用，通过系统和积极地根据其器械售后体验收集信息，以更新其技术文件，

并与负责警戒和市场监管活动的国家主管机构合作。为此，制造商应根据质量管理体系并基于上市后监管计划，建立一个综合的上市后监管体系。且应借助在上市后监管中收集的相关数据和信息，以及从任何执行的预防和/或纠正措施中吸取的经验教训，更新技术文件的任何相关部分，如风险评估相关文件和临床评估，还应确保文件透明度。Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set up

under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.

（75） 为更好地保障上市器械相关健康和安全问题，应当通过创建欧盟级别的中央门户网站报告严重事件和现场安

全纠正措施，使得用于器械的电子警戒系统更有效。In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.

（76）

成员国应采取适当措施，提高医护专业人员、使用者和患者对报告事件的重要性的认识。应该鼓励医护专业人员、使用者和患者使用统一格式在国家级别报告可疑的严重事件。国家主管机构应通知制造商任何疑似严重事件，并且当制造商确认此等事故发生时，相关主管机构应确保采取适当的跟踪措施，以尽量避免此类事件的再次发生。Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incidents and, where a manufacturer confirms that such an incident has occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.

（77）

应在国家级别评估报告的严重事件和现场安全纠正措施，但应确保在类似事件发生时进行协调，或者必须在多个成员国进行现场安全纠正措施，目的是共享资源并确保纠正措施的一致性。The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action.

（78）

在事故调查背景中，主管机构应酌情考虑利益相关者（包括患者和医护专业人员组织和制造商协会）提供的信息和意见。In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations.

（79）

应清楚区分临床研究期间的严重不良事件或器械缺陷报告和器械投放市场后发生的严重事件报告，以避免重复报告。The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.

（80）

本法规应包含市场监管规则，以加强国家主管机构的权利和义务，确保市场监管活动的有效协调，并说明适用的流程。Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.

（81）

可能对风险利益分析产生重大影响，并且可能导致不可接受风险的，不严重或预期副作用事件，如数量或严

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重程度出现显著增加，均应向主管机构报告，以允许其进行评估和采取适当的措施。Any statistically significant increase in the number or severity of incidents that are not serious or in expected side-effects that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures.

（82）

应当成立一个由成员国指派的专家（根据其在医疗器械（包括体外诊断医疗器械）领域中的职务和专长）组成的专家委员会，即医疗器械协调小组（MDCG），以完成本法规和欧洲议会和理事会第2017/746号法规（2）赋予该小组的使命，向委员会提供建议，以及协助委员会和成员国确保本法规的协调实施。MDCG应当能够建立其分小组，以便在医疗器械（包括体外诊断医疗器械）领域提供必要的、有见地的专门技术知识。在建立分小组时，应适当考虑在医疗器械领域中加入现有欧盟级别团体的可能性。An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by this Regulation and by

Regulation (EU) 2017/746 of the European Parliament and of the Council (25), to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised

implementation of this Regulation. The MDCG should be able to establish subgroups in order to have

access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices.

________________________

（1）欧洲议会和理事会于2010年9月22日签发的关于用于科学目的动物保护的第2010/63/EU号指令(OJL276, 20.10.2010, p. 33)。 （2）欧洲议会和理事会于2017年4月5日签发的关于体外诊断医疗器械第2017/746号（EU）法规，废止了第98/79/EC号指令和委员会第

2010/227/EU号决议（见本“官方公报”第176页）

（83） 应由委员会根据最新的临床、科学或技术专业知识，委任专家委员会和专家实验室，以便向委员会、MDCG、

制造商和与本法规实施有关的公告机构提供科学、技术和临床协助。此外，专家小组应履行对高风险器械的公告机构临床评估的评定报告提出自身意见的义务。Expert panels and expert laboratories should be designated by the Commission on the basis of their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this Regulation. Moreover, expert panels should fulfil the tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of certain high-risk devices.

（84） 通过在协调机构的指导下的信息交流和协调评估，国家主管机构之间进行的更密切的协调，对于确保内部市场，

特别是在临床研究和警戒领域的统一高水平的健康和安全保护至关重要。协调交流和评估的原则也应适用于本法规中说明的其他机构活动，例如公告机构名称，并应在器械的市场监管领域中鼓励使用该原则。活动的协作、协调和沟通也应在国家层级上引领更有效地利用资源和专门知识。Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is

essential for ensuring a consistently high level of health and safety protection within the internal market, in particular in the areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and

should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level.

（85） 委员会应向协调国家主管机构提供科学、技术和相应的后勤支持，并确保器械的监管制度在欧盟层级基于可

靠的科学证据能够得以有效且统一地实施。The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively

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and uniformly implemented at Union level based on sound scientific evidence.

（86） 欧盟及成员国应酌情积极参与医疗器械领域的国际监管合作，以促进医疗器械安全相关信息的交流，并促进

国际监管准则的进一步发展，从而推动其他法规司法管辖区采用与本法规所规定卫生与安全保障水平同等的法规。The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation.

（87） 成员国应采取一切必要措施，确保本法规的规定得到执行，包括针对违反行为制定有效、相称和劝诫性的处

罚。Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement.

（88） 同时，本法规不得影响成员国对国家一级活动征收费用的权利，但成员国在决定相关费用级别和结构之前应

通知欧盟委员会和其他成员国，以确保透明度。为进一步确保透明度，应根据要求公开费用结构和级别。Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other

Member States before they decide on the level and structure of such fees. In order to further ensure transparency, the structure and level of the fees should be publicly available on request.

（89） 本法规尊重基本权利，并遵守《宪章》所认可的原则，尤其是人类尊严、人身完整性、个人资料的保护、艺

术和科学自由、开展业务的自由和财产权。成员国应根据这些权利和原则应用本法规。This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles.

（90） 根据TFEU第290条，应当授予委员会批准授权法案的权限，以便修订本法规的某些非必要规定。特别重要

的是，委员会在其筹备工作期间，包括在专家层级上进行适当的咨询，且应根据2016年4月13日《改善的立法机构间协议》所规定的原则（1）进行这些咨询。特别是，为确保平等参与制订授权法案，欧洲议会和理事会将与成员国专家同时收到所有文件，并且其专家可系统地参加委员会专家组会议，以讨论授权法案的制订。The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular

importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (26). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts.

（91） 为确保执行本法规的条件一致，应向委员会授予执行权力。应根据欧洲议会和理事会第182/2011号法规（2）

行使这些权力。In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (27).

___________________

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（1） OJ L123, 12.5.2016, p. 1.

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（2） 欧洲议会和理事会2011年2月16日签发的关于规定行使这些权力及成员国管制委员会行使其执行权力机制的规则和一般原则的第

182/2011号法规(OJ L55, 28.2.2011, p.13)。

（92） 实施细则应借助咨询程序，其中规定了制造商安全与性能总结的数据要素形式，并建立了表述以及自由销售证

书模式的形式与表述，因为实施细则具有程序性，并且不会直接对欧盟层级的卫生与安全产生影响。The advisory

procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and clinical performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level.

（93） 若存在紧急理由，即涉及到欧盟领土扩张，而相关国家豁免适当符合性评估流程，则委员会应采取立即适用的

实施细则。The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require.

（94） 为使委员会能任命签发机构、专家小组和专家实验室，应授予委员会实施权限。In order to enable it to designate

issuing entities, expert panels and expert laboratories, implementing powers should be conferred on the

Commission.

（95） 为使经济运营商，特别是中小型企业、指定机构、成员国和委员会能够适应本法规引入的变化并确保其适当的

应用，适当的做法是为这种适应和后期的组织安排提供充分的过渡期。但应当尽快实施法规中直接影响成员国和委员会的特定部分。特别重要的是，在本法规生效之日，根据新的要求指定足够数量的公告机构，以避免市场上医疗器械的任何短缺。尽管如此，在法规生效日期前，有必要根据本法规要求任命一个公告机构，但不得影响这些公告机构按照第98/79/EC号指令任命的有效性，并且不影响其按照该指令继续签发有效证书的权限，直至本法规生效。To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made. However, certain parts of the Regulation that directly affect

Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be

designated in accordance with the new requirements so as to avoid any shortage of medical devices on the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the

requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and 93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of application of this Regulation.

（96） 为确保顺利过渡至器械和证书注册的新规定，按照本法规，向在欧盟层级别设置的电子系统提交相关信息的义

务（若已根据计划开发了相应的IT系统）应当在本法规适用日期后的18个月内完全有效。在此过渡期内，第90/385/EEC和93/42/EEC号指令的某些条款应继续有效。但根据这两项法规在欧盟层级设立的相关电子系统中注册的经济运营商和指定机构应视为符合成员国根据规定所采取的注册要求，以避免多次注册。In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation. During this transitional period, certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However, in order to avoid

multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.

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（97） 为使UDI系统顺利引入，将UDI载体加在器械标签上义务的生效时机还应当在本法规生效日期之后一年至五

年之间完成，具体取决于相关器械的类别。In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned.

（98） 应废除第90/385/EEC号和第93/42/EEC号指令，以确保只有一套规则适用于医疗器械投放市场及本法规所涉及

相关问题。制造商依然有义务为其投放市场的器械提供相关文件，而制造商和成员国依然有义务按照该指令开展已投放市场器械的监管活动。虽然应当由成员国决定如何组织监管活动，但建议成员国使用与报告依照本法规投放市场之器械相同的工具来报告使用依照该指令投放市场的器械。此外，为确保从旧框架顺利过渡到新框架，恰当的做法是规定欧盟委员会第207/2012号法规（1）和欧盟委员会第722/2012号法规（2）应持续有效并继续适用，除非并直至其被执行委员会根据本法规通过的实施细则废除。Directives 90/385/EEC and

93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on

devices placed on the market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission

Regulation (EU) No 207/2012 (28) and Commission Regulation (EU) No 722/2012 (29) should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation. Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also remain in

force and continue to apply until the date when Eudamed becomes fully functional. Conversely, no such maintenance in force is required for Commission Directives 2003/12/EC (30) and 2005/50/EC (31) and Commission Implementing Regulation (EU) No 920/2013 (32). _____________________

（1）委员会于2012年3月9日签发的关于医疗器械使用电子机构的委员会第207/2012号法规(OJ L72, 10.3.2012, p. 28)。

（2） 委员会于2012年8月8日签发的关于在委员会关于有源植入式医疗器械和医疗器械第90/385/EEC和93/42/EEC指令规定要求特殊要

求的委员会第722/2012号法规。

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在欧洲医疗器械数据库完全启用日之前，在实施这些指令和第98/79/EC号指令时所通过的第2010/227/EU号决议应继续有效并继续适用。相反，委员会第2003/12/EC（1）和2005/50/EC号指令（2）和委员会第920/2013号实施法规（3）无需维持效力。

（99） 本法规的要求应适用于自本法规生效之日起投放市场或投入使用的所有器械。但为提供平稳过渡，应能够允许

器械自该日期起的有限期限内，根据第90/385/EEC或93/42/EEC号指令颁发的有效证书投放市场或投入使用。The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.

(100) 欧洲数据保护主管根据欧洲委员会第45/2001号法规第28（2）条发表了意见（4）。The European Data Protection

Supervisor has given an opinion (33) pursuant to Article 28(2) of Regulation (EC) No 45/2001.

（101） 出于本法规的目标，即确保医疗器械境内市场的顺利运转并确保医疗器械的高质量和安全性，因此若患者、使

用者及其他人员的卫生与安全得到高水平的保护，无法由成员国充分实现，且由于规模和效果，可更好地在欧盟层级中实现时，欧盟可根据《欧盟条约》第5条规定的辅助性原则采取措施。按照该条款中规定的比例原则，本法规将不会超过实现该目标所需范围。Since the objectives of this Regulation, namely to ensure the

smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the

principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

已经通过本法规：HAVE ADOPTED THIS REGULATION CHAPTER I

第I章

范围及定义

SCOPE AND DEFINITIONS 第1条 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。his 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 analogous 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

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3.

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.

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)。 2

（） 2005年8月11日委员会签发的关于医疗器械第93/42/EEC号指令范围内髋、膝盖和肩膀关节替换的委员会第2005/50/EC号指令（OJ

L210, 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).。 ４

（）OJ C358, 7.12.2013, p. 10.

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4.

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5.

6.

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’.

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 acts in 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. 本法规不适用于：This Regulation 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；

（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。

（c） 欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品；

（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；

（e） 欧洲委员会第1223/2009号法规所涵盖的美容产品；

（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。

（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；

（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；

（i）第178/2002号（EU）法规所涵盖的食品。

in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; (a) (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a productfalls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product; advanced therapy medicinal products covered by Regulation (EC) No 1394/2007; (c) (d) 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 toparagraph 8 of this Article; cosmetic products covered by Regulation (EC) No 1223/2009; (e) (f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of themhowever this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or thderivatives, which are non-viable or are rendered non-viable; (g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or producontaining or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable; (h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achievesupport the intended purpose of the product; food covered by Regulation (EC) No 178/2002. (i)

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7.

8.

9.

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 this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.

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 an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation. However, if the action of that substance is principal and not ancillary to that of the device, 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 the safety and performance of the device part are concerned.

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(OJ L136, 30.4.2004, p.

1)。

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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 action ancillary 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. 12

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.

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. 14.

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

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.

本法规不影响有关卫生服务和医疗保健的组织、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 use certain 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 expression in 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.

第2条Article 2

15

定义 Definitions

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5.5.2017

就本法规而言，应适用以下定义：For the purposes of this Regulation, the following definitions apply:

“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：

– – – – –

对疾病的诊断、预防、监护、预测、预后、治疗或缓解； 对损伤或残疾的诊断、监控、治疗、缓解、补偿 解剖、生理或病理过程或状态的研究、替代、调节，

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。

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；

以下产品也应视为医疗器械：

– –

具有控制或支持用途的器械。

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

‘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 compensation 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, — 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. 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. __________________________

（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)。

(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 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) “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

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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

L117/32 EN 欧盟官方公报

the assignment of a new lifetime to the refurbished device;

(32)

5.5.2017

“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

5.5.2017 EN 欧盟官方公报

assess the safety or performance of a device;

（46） （47）

L117/33

“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

L117/34 EN 欧盟官方公报 5.5.2017

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.

L117/38 EN 欧盟官方公报

industrial scale

6.

5.5.2017

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).

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