MDREU2017745欧盟医疗器械最新法规(中英对照版~).doc

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1、#*欧盟官方欧盟官方公报公报中文版中文版立法立法L117第第 60 卷卷2017 年年 5 月月 5 日日内容内容I 立法法案立法法案法规法规欧洲议会和理事会于欧洲议会和理事会于 2017 年年 4 月月 5 日签发的关于医疗器械第日签发的关于医疗器械第 2017/745 号法号法规，修订了第规，修订了第 2001/83/EC 号指令，第号指令，第 178/2002 号（号（EU）法规和第）法规和第1223/2009 号（号（EU）法规，并废除了理事会第）法规，并废除了理事会第 90/385/EEC 号和第号和第93/42/EEC 号指令号指令（1）1欧洲议会和理事会于欧洲议会和理事会于 20

2、17 年年 4 月月 5 日签发的关于体外诊断医疗器械第日签发的关于体外诊断医疗器械第2017/746 号（号（EU）法规并废除了第）法规并废除了第 98/79/EC 号指令和理事会第号指令和理事会第2010/227/EU 号决议号决议176_（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。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。所有其他法案的标题均以粗体打印，并以星号开头。#*#*I（立法法案）（立法法案）法规法规欧洲议会和理事会于欧洲议会和理事会于 2017 年年

3、 4 月月 5 日签发的关于医疗器械第日签发的关于医疗器械第 2017/745 号法规，修订了号法规，修订了第第 2001/83/EC 号指令，第号指令，第 178/2002 号（号（EU）法规和第）法规和第 1223/2009 号（号（EU）法规，并废）法规，并废除了理事会第除了理事会第 90/385/EEC 号和第号和第 93/42/EEC 号指令号指令（EEA 相关性文本）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

4、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, othe

5、r 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

6、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

7、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 hig

8、h 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

9、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 Regu

10、lation sets high standards of #*quality and 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._（1）2013 年 2 月 14 日意见（OJ C 133, 9.

11、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

12、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

13、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

14、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

15、 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 o

16、f 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

17、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 inst

18、ruments. 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

19、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 t

20、he 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

21、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 borderl

22、ine 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 th

23、e 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),

24、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 deci

25、sion 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

26、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 t

27、erms 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 thi

28、s 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._（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） 。（

29、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） 。#*（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

30、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 h

31、uman 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

32、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

33、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. Suc

34、h 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

35、 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 ori

36、gin, 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 pr

37、oducts 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

38、（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 leve

39、l 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

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

41、t 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 2

42、014/30/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, th

43、is 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 appli

44、cation 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,

45、including protection from radiation._（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 20

46、03 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

47、 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)。#*（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

48、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 us

49、ed 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 softwares 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