MDR-EU-2017-745-欧盟医疗器械法规-前言综述

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本文转载自“木之唐咨询”

法规 REGULATIONS

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）REGULATION (EU) 2017/745 OF THE EUROPEANPARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC,Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC(Text with EEA relevance)


欧洲议会和欧盟委员会，THE EUROPEAN PARLIAMENT AND THECOUNCIL OF THE EUROPEAN UNION,


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，Having regard to the Treaty on the  Functioning of the European Union, and in particular Article 114 and Article 168(4)(c)thereof,


并考虑到欧盟委员会提案，Having regard to the proposal from the European Commission,


于立法草案转交各国议会后，After transmission of the draft legislative act to the national parliaments,


考虑到欧洲经济和社会委员会之意见（1），Having regard to the opinion of the European Economic and Social Committee (1),在咨询地区委员之后，After consulting the Committee of the Regions,


根据一般立法程序运作（2），Acting in accordance with the ordinaryl egislative procedure (2),


鉴于：Whereas:


（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 invitro diagnostic medical devices. However, a fundamental revision of those Directivesis 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，并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 asregards 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 safety for medical devicesby ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in aclinical investigation is protected._________________

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

Opinion of 14 February 2013 (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）。Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet publishedin the Official Journal).
（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）。Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable
（4）1993年6月14日签发的关于医疗器械的理事会第93/42EEC号指令（OJ L 169，12.7.1993，p. 1）。Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169.


（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 putinto 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 provisionson Unique Device Identification, general safety and performance requirements,technical documentation, classification rules, conformity assessment proceduresand 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 aspecific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products inborderline 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.________________________（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）。Regulation (EC) No178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (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）。Regulation (EC) No1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,（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）。Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (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。Asis the case for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives 90/385/EEC and93/42/EEC and hence from this Regulation, it should be clarified that products that contain or consist of viable biological materials or viable or ganisms 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 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.______________________（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）。Regulation (EC) No1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC)No 726/2004 (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）。Directive2004/23/EC of the European Parliament and of the Council of 31 March 2004 onsetting standards of quality and safety for the donation, procurement, testing,processing, preservation, storage and distribution of human tissues and cells(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）。Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing,processing, storage and distribution of human blood and blood components (OJ L33, 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）。Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (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)。Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electro magnetic compatibility (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)。Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation,and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,97/43/Euratom and 2003/122/Euratom (OJ L 13, 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。Its hould 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 adiagnostic 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 requirements, and the requirements forclinical 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2015年9月9日的指令(EU) 2015/1535，规定了技术法规领域和社会服务信息规则的程序(OJ L241, 17.9.2015, p. 1)。Directive(EU) 2015/1535 of the European Parliament and of the Council of 9 September2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015,p. 1).（2）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）。Regulation(EU) No 1025/2012 of the European Parliament and of the Council of 25 October2012 on European standardisation, amending Council  Directives  89/686/EEC and  93/15/EEC  and Directives  94/9/EC,  94/25/EC, 95/16/EC,  97/23/EC,  98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/ECand 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).（3）欧洲议会和理事会于1998年10月27签发的有关体外诊断的第98/97号指令(OJ L 331,7.12.1998, p. 1)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, 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). Regulation (EC) No 765/2008 of the European Parliament and of the Councilof 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation(EEC) No 339/93 (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）。Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).


（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/EECand 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 publichealth 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。Inview of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union andnational law, it is appropriate to require manufacturers to have measures inplace 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 inconformity 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 theclinical 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 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 shouldbe 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 amanufacturer'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)。Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws,regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).


(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 withinthe 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 thecase-law of the Court of Justice (20)in other relevant sectors and existing good practice in the field of medicaldevices.


(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。There processing 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 forsecurity 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。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 putinto service in accordance with their intended purpose. Member Statesshould not create obstacles to the placing on the market or putting intoservice of devices that comply with the requirements laid down in this Regulation.However, Member States should be allowed to decide whether to restrict theuse of any specific type of device in relation to aspects that are not coveredby 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 wastedisposal 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-madedevices, 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Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C‑400/09 and C‑207/10,ECLI:EU:C:2011:519.


（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 developand 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'selectronic 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, asingle 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 suchincidents 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 accordance with Regulation (EC) No 45/2001, the Commission should be designatedas 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位置，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 inparticular 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, inaccordance 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。Notifiedbodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by theauthority responsible for notified bodies. That evaluation should be part ofthe 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 ensur econtinuous compliance by manufacturers after receipt of the original certification.________________________（1）    委员会于2010年4月19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(OJ L 102,23.4.2010, p. 45).Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).（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/EC号指令(OJ L281, 23.11.1995,p. 31)。Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 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)。Regulation(EC) No 45/2001 of the European Parliament and of the Council of 18 December2000 on the protection of individuals with regard to the processing of personaldata by the Community institutions and bodies and on the free movement of such data (OJ L 8,12.1.2001, p. 1).


（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。Inview, 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 administerand/or remove a medicinal product, notified bodies should, except in certaincases, 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 inrelation 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 under gone 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 inline 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 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 suitablerisk-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 suchdevices. The classification rules should take into account the place where thedevice performs its action in or on the human body, where it is introduced orapplied, and whether a systemic absorption of the substances of which thedevice 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 ageneral rule, under the sole responsibility of manufacturers in view of the lowlevel 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, inparticular with regard to whether it is on the market, withdrawn from themarket 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 withthe 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。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 inline with the most recent version of the World Medical Association Declarationof Helsinki on Ethical Principles for Medical Research Involving HumanSubjects.


（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 onmedicinal 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。Wherea clinical investigation is to be conducted in more than one Member State,the sponsor should have the 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In capacitated subjects, minors, pregnant women and breastfeeding women require specific protection measures. However, it should beleft 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.


（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 systemand 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 hasoccurred, the authorities concerned should ensure that appropriate follow-upaction 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 becarried 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。Thereporting of serious adverse events or device deficiencies during clinicalinvestigations and the reporting of serious incidents occurring after a device hasbeen placed on the market should be clearly distinguished to avoid doublereporting.

（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。Ruleson 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 expertisein 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 theCouncil (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 tonecessary in-depth technical expertise in the field of medical device sincluding 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)。Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010on the protection of animals used for scientific purposes (OJ L 276,20.10.2010, 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）Regulation (EU)2017/746 of the European Parliament and of the Council of 5 April 2017 on invitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).


（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。Expertpanels and expert laboratories should be designated by the Commission on the basis of their up-to-date clinical, scientific or technical expertise, with theaim 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 thetasks 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 are as 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 efficientuse 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 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。Whilstthis Regulation should not affect the right of Member States to levy feesfor 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 provisionsof 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 delegatedacts, the European Parliament and the Council receive all documents at the sametime 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 182/2011of the European Parliament and of the Council (27).___________________（1）OJ L123, 12.5.2016, p. 1.（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)。Regulation(EU) No 182/2011 of the European Parliament and of the Council of 16 February2011 laying down the rules and general principles concerning mechanisms forcontrol by Member States of the Commission's exercise of implementing powers(OJ L 55, 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 formand presentation of the data elements of manufacturers' summaries of safety andclinical performance, and that establish the model for certificates of freesale, 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 anational 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 Statesand the Commission to adapt to the changes introduced by this Regulation and toensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the or ganisational 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 aspossible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated inaccordance with the new requirements so as to avoid any shortage of medicaldevices on the market. Nonetheless, it is necessary that any designation of anotified body in accordance with the requirements of this Regulation prior tothe date of its application be without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and93/42/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 setup at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only becomefully 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.


（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/EECand 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 coveredby 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 devicesplaced 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 further more 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 requiredfor 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)。Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28).（2）    2012年8月8日的（EU）第722/2012号委员会法规，涉及理事会指令90/385 / EEC和93/42 / EEC中针对活性植入式医疗器械和利用动物组织的医疗器械。（OJ L 212，9.8.2012，p.3）。Commission Regulation(EU) No 722/2012 of 8 August 2012 concerning particular requirements as regardsthe requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufacture utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).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。Decision 2010/227/EU adopted in implementation of those Directives and Directive98/79/EC should also remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely, no such maintenance in force isrequired for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and Commission Implementing Regulation (EU) No 920/2013 (3).


（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 marketor put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EECor 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。Sincethe objectives of this Regulation, namely to ensure the smooth functioning ofthe 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 THISREGULATION