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1、欧盟官方公报中文版立法L117第60卷2017年5月5日内容 I 立法法案法规欧洲议会和理事会于2017年4月5日签发的关于医疗器械第2017/745号法规，修订了第2001/83/EC号指令，第178/2002号（EU）法规和第1223/2009号（EU）法规，并废除了理事会第90/385/EEC号和第93/42/EEC号指令（1）1欧洲议会和理事会于2017年4月5日签发的关于体外诊断医疗器械第2017/746号（EU）法规并废除了第98/79/EC号指令和理事会第2010/227/EU号决议176_（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
2、有效。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）法规欧洲议会和理事会于2017年4月5日签发的关于医疗器械第2017/745号法规，修订了第2001/83/EC号指令，第178/2002号（EU）法规和第1223/2009号（EU）法规，并废除了理事会第90/385/EEC号和第93/42/EEC号指令（EEA相关性文本）欧洲议会和欧盟委员会，考虑到“欧盟运作条约”，特别是其中第114条和第168（4）（c）条规定，并考虑到欧盟委员会提案，于立法草案转交各国议会后，考虑到欧洲经济和社会委员会之意见（1），在咨询地区委员之后，根据一般立法程序运作（2），鉴于：(1) 理事会第9
3、0/385/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 Directive90/385/EEC(3) and Council Directive93/42/EEC(4) constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devic
4、es. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.(2) 本法规旨在确保区域内医疗器械市场的平稳运作，在为患者和使用者提供高水平健康保护的基础上，同时考虑
5、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 inte
6、rnal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medica
7、l 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 Article114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation ha
8、rmonises 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 Article168(4)(c)TFEU, this Regulation sets high standards of quality and safet
9、y 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, 9.5.2013, 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
10、月7日首次审阅时理事会的立场（尚未在官方公告内公布）。（3）1990年6月20日签发的关于成员国有关可植入医疗器械法律的理事会第90/38/EEC号指令（OJ L 331, 7.12.1998, p.1）。（4）1993年6月14日签发的关于医疗器械的理事会第93/42 EEC号指令（OJ L 169，12.7.1993，p. 1）。（3）本法规并不寻求协调有关医疗器械投入使用后，在市场上进一步供应之规则，例如二手销售。This Regulation does not seek to harmonise rules relating to the further making availabl
11、e on the market of medical devices after they have already been put into service such as in the context of second-hand sales.（4）应大大加强现有监管方法的关键要素，例如公告机构监管、符合性评估流程、临床研究和临床评价，警戒和市场监管，同时引入确保医疗器械透明度和可追溯性之规定，以改善健康和安全性。Key elements of the existing regulatory approach, such as the supervision of notified bo
12、dies, 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
13、，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 For
14、ce (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions
15、 on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations.（6）出于历史原因，第90/385/EEC号指令所涵盖的有源植入式医疗器械以及第93/42/EEC号指令所涵盖的其他医疗器械通过另外两个单独的法律进行管控。为简化起见，经过若干次修订的两项指令均应替换为适用于除体外诊断医疗器械外所有医疗器械的单一立法法案。For historical reasons, active implantable medical devices, covered by Directive90/385/EEC, and other medical devices, covered by Directive93/42/EEC, were regulated in two separate legal instru
