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of products in question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
尽管存在第122条规定，根据第93/42/EEC号指令为附录XVI所涵盖的医疗器械的产品符合相关成员国措施仍应继续有效，直至第一子段所要求的该产品组的相关通用规范适用日为止。Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
本规范也适用在欧盟进行的有关第一子段所述产品的临床研究。This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
具有医疗和非医疗预期目的器械应逐渐的满足适用于具有预期医疗目的器械要求和适用于无预期医疗目的器械的那些要求。Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.
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（1） 2003年2月3日委员会签发的关于医疗器械第93/42/EEC号指令范围内乳房植入物的再分类的委员会第2003/12/EC号指令(OJ L28,
4.2.2003, p. 43)。 2
（） 2005年8月11日委员会签发的关于医疗器械第93/42/EEC号指令范围内髋、膝盖和肩膀关节替换的委员会第2005/50/EC号指令（OJ
L210, 12.8.2005, p. 41）。 ３（）2013年9月24日委员会签发的关于根据关于有效可植入医疗器械委员会第90/385/EEC号指令和关于医疗器械第93/42/EEC号指令指
定和监督公告机构的委员会第920/2013号实施条例(OJ L253, 25.9.2013, p. 8).。 ４
（）OJ C358, 7.12.2013, p. 10.
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就本法规而言，根据第2段，本法规适用的附录XVI所列医疗器械、医疗器械附录及医疗产品均在下文中简称为“器械”。 For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
如从其特性和风险方面来看，考虑到投放市场的具有医疗目的器械与不具医疗目的产品之间的相似性具有正当理由，则委员会应有权根据第115条借助增加新产品组以通过授权法案从而修订附录XVI中的清单，以便保护使用者或其他人员的健康和安全或所涉及公共卫生的其他方面。Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of
products, in order to protect the health and safety of users or other persons or other aspects of public health. 本法规不适用于：This Regulation does not apply to:
（a）欧盟第2017/746号法规所涵盖的体外诊断医疗器械；
（b）如第2001/83/EC号指令第1条第2点中所定义的医疗产品。在确定产品是否属于第2001/83/EC号指令或
本法规的范围时，应特别考虑产品的主要作用模式。
（c） 欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品；
（d） 人类血液或血液制品、人源的血浆或血细胞，或者在投放市场或投入使用时，包含此类血液制品、血浆
或细胞的器械，但本条第8段所述的器械除外；
（e） 欧洲委员会第1223/2009号法规所涵盖的美容产品；
（f） 动物源的移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但本法规适用于使用非活性
或活性动物来源的组织或细胞或其衍生产品制造而成的器械。
（g） 第2004/23/EC号指令所涵盖的人源移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但
器械适用于使用活性或非活性人源组织或细胞的衍生产品制造而成的器械；
（h）除了（d）、（f）和（g）点中述及的那些含有或包括活性生物物质或活菌体（包括活体微生物、细菌、真菌
或病毒）以实现或支持产品预期用途的产品；
（i）第178/2002号（EU）法规所涵盖的食品。
in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; (a) (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a productfalls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product; advanced therapy medicinal products covered by Regulation (EC) No 1394/2007; (c) (d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred toparagraph 8 of this Article; cosmetic products covered by Regulation (EC) No 1223/2009; (e) (f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of themhowever this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or thderivatives, which are non-viable or are rendered non-viable; (g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or producontaining or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable; (h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achievesupport the intended purpose of the product; food covered by Regulation (EC) No 178/2002. (i)
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在投放市场或投入使用时，作为欧盟第2017/746号法规第2条第2点所界定的体外诊断医疗器械的一个整体部分任何器械，应受第2017/746号法规管制。本法规的要求应适用于体外诊断医疗器械部件。Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.
若器械在投放市场或投入使用时，包含某一种必不可少的物质，而该物质若单独使用将被视为第2001/83/EC号指令第1条第2点所界定的医药产品，其中包括该指令第1条第10点所定义的人体血液或血浆来源的药物制品，并且具有辅助器械的作用，该器械应根据本法规进行评估和授权。
但是，若该物质的作用是主要作用，而不是辅助该器械的作用，则综合产品应由适用的欧洲议会和理事会第2001/83/EC号指令或第726/2004号法规（1）管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a
medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation. However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the
Council (34), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
若器械适用于第2001/83/EC号指令第1条第2点定义的药品，则该器械应受本法规管制，且不影响该指令的规定以及欧洲委员会关于药品的第726/2004号法规。Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
但若该器械预期与药品一起使用，且该药品与器械组成一个整体的方式投放市场，该产品专用于给定的组合并且不可重复使用，则产品应按第2001/83/EC号指令或欧洲委员会第726/2004号法规管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。However, if the device
intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or
Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
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（1） 2004年3月31日欧洲议会和理事关于规定授权和监督人用和兽用医疗产品和成立欧洲药品管理局的共同体程序(OJ L136, 30.4.2004, p.
1)。
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当器械在投放市场或投入使用时，包含必不可少的人体非活性组织或细胞或其衍生物，且具有辅助器械的作用，则应按照本法规对该器械进行评估和授权。在这种情况下，第2004/23/EC号指令中规定的捐赠、采购和测试规定应适用。Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
但若这些组织或细胞或其衍生物的作用是主要的，而不是辅助器械的作用，且产品不受欧洲委员会第1394/2007号法规管制，则该产品应受第2004/23/EC号指令管制。在这种情况下，本法规附录I中规定的相关通用安全与性能要求应适用于器械部件的安全与性能。However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by
Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned. 11. 12
本法规属于第2014/30/EU号指令第2(3)条所辖欧盟特别立法。
This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
存在指令中所述相关风险的情况下，作为欧洲议会和欧洲委员会关于机械的第2006/42/EC号指令（1）第2段第a点所列器械同样应满足该指令附录I中规定的基本卫生与安全要求，这些要求比本法规附录I第II章所规定的通用安全与性能要求更为具体。Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (35) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation. 13. 14.
本法规不影响第2013/59/Euratom号指令的应用。This Regulation shall not affect the application of Directive 2013/59/Euratom
本法规不影响成员国在本法规未涵盖的方面限制使用任何特定类型器械的权利。This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.
本法规不影响有关卫生服务和医疗保健的组织、交付或融资的国家法律，例如要求某些器械只能以医疗处方提供，要求只有某些卫生专业人员或卫生护理机构可分发或应用某些器械，或者其应用必须伴随特定的专业咨询。This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the
requirement that only certain health professionals or healthcare institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling. 16.
本法规不限制新闻自由或媒体中的言论自由，只要这些自由在欧盟和成员国中得到保障，特别是《欧洲联盟基本权利宪章》第11条。 Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.
第2条Article 2
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定义 Definitions
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就本法规而言，应适用以下定义：For the purposes of this Regulation, the following definitions apply:
“医疗器械”是指由制造商单独使用或组合用于人体的以下一种或多种特定医疗目的任何仪器、设备、器具、软件、植入物、试剂、材料或其他物品：
– – – – –
对疾病的诊断、预防、监护、预测、预后、治疗或缓解； 对损伤或残疾的诊断、监控、治疗、缓解、补偿 解剖、生理或病理过程或状态的研究、替代、调节，
通过对来自人体的样本（包括器官、血液、捐献的组织）进行体外检测来提供信息。
其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些
方式参与但是只起辅助作用；
以下产品也应视为医疗器械：
– –
具有控制或支持用途的器械。
专门用于器械的清洁、消毒或灭菌，如第1（4）条和本点第一子段第中所述
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, — and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. __________________________
（1） 2006年5月17日欧洲议会和理事会签发的关于机械和修订第95/16/EC号指令的第2006/42/EC号指令(OJ L157, 9.6.2006, p. 24)。
(2) “医疗器械附件”是指制造商计划将其与一个或几个特定医疗器械一起使用，使该医疗器械可按照其预期用途进行使用，或特定或直接辅助医疗器械来实现其预期用途的功能，但其不是医疗器械的物件；‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its
manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
(3) “定制器械”是指根据国家法律授权的任何人员的书面处方，通过该人员的专业资格知识而专门制造的器械，具有特有的设计特性，计划专用于特定患者，并专门满足个人条件和需要。 ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national