L117/4 EN 欧盟官方公报 5.5.2017
（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
5.5.2017 EN 欧盟官方公报 L117/5
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）。 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)。
L117/6 EN 欧盟官方公报 5.5.2017
（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
5.5.2017 EN 欧盟官方公报 L117/7
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
L117/8 EN 欧盟官方公报 5.5.2017
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