Article 1 Subject matter and scope
1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by
► M1 26 May 2021 ◄. They shall apply as from six months after the date of their entry into force or from ►M1 26 May 2021 ◄, whichever is the latest.
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.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
3. 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.
4. 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’.
5. 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.
6. This Regulation does not apply to:
(a) in vitro diagnostic medical devices covered by Regu lation (EU) 2017/746;
(b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
(c) advanced therapy medicinal products covered by Regu lation (EC) No 1394/2007;
(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 to in paragraph 8 of this Article;
(e) cosmetic products covered by Regulation (EC) No 1223/2009;
(f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, 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 products containing 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 achieve or support the intended purpose of the product;
(i) food covered by Regulation (EC) No 178/2002.
7. 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 Regu lation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.
8. 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 (1), 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.
9. 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.
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 Regu lation (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.
10. 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.
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 Regu lation shall apply as far as the safety and performance of the device part are concerned.
11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
12. 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 (1) 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. This Regulation shall not affect the application of Directive 2013/59/Euratom.
14. 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.
15. 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. 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1条主题和范围
1,本法规规定了有关在国际市场上投放市场,在市场上出售或投入使用的医疗器械及其附件的规则。本法规也适用于在联盟中进行的有关此类医疗器械和附件的临床研究。
2,从适用第9条通过的通用规范之日起,本法规还应适用于附件XVI中所列的,具有预定医疗用途的产品组,并应考虑到最新技术水平;以及尤其是基于类似技术的,具有医疗用途的类似设备的现有统一标准。附件XVI中列出的每种产品组的通用规范至少应解决附件I所述产品组的风险管理的应用,并在必要时进行有关安全性的临床评估。
必要的通用规范应在2020年5月26日之前采用。它们应自其生效之日起六个月或2020年5月26日起适用,以最新的为准。
尽管有第122条的规定,各成员国根据第93/42 / EEC号指令对附件XVI涵盖的产品作为医疗器械的资格所采取的措施应一直有效,直到相关共同点的第一款所指的适用日期为止。该组产品的规格。
本法规也适用于国际电联针对第一项所述产品进行的临床研究。
3,具有医疗和非医疗目的的设备应累计满足适用于有医疗目的的设备和适用于无医疗目的的设备的要求。
4.就本法规而言,本法规根据第2款适用于附件XVI的医疗器械,医疗器械配件和产品以下简称“器械”。
5,由于具有预期医疗目的的设备与不具有预期医疗目的的产品在特性和风险方面的相似性是合理的,因此委员会有权根据第115条采用授权行为通过增加新的产品类别来修改附件XVI中的清单,以保护使用者或其他人的健康和安全或公共卫生的其他方面。
6,本法规不适用于:
(a)法规(EU)2017/746涵盖的体外诊断医疗设备;
(b)指令2001/83 / EC第1条第2点所定义的药品。在确定产品属于指令2001/83 / EC还是本法规的过程中,应特别考虑产品的主要作用方式;
(c)第1394/2007号法规(EC)涵盖的先进治疗药物;
(d)人类血液,血液制品,血浆或人类血细胞或在市场上投入使用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款所指器械除外;
(e)第1223/2009号法规(EC)所涵盖的化妆品;
(f)动物来源的移植物,组织或细胞,或其衍生物,或含有它们或由其组成的产品;但是,本法规的确适用于利用动物来源的组织或细胞或它们的衍生物制造的,不能存活或变得不能存活的设备;
(g)第2004/23 / EC号指令涵盖的人类来源的移植物,组织或细胞,或其衍生物,或包含或由其组成的产品;但是,本法规的确适用于使用无生命或变得无生命的人类组织或细胞衍生物制造的器械;
(h)除(d),(f)和(g)点所提及的产品以外的产品,其包含或由活的生物材料或活的有机体组成,包括活的微生物,细菌,真菌或病毒,以便实现或支持产品的预期目的;
(i)第178/2002号法规(EC)涵盖的食物。
7,任何在市场上投入使用或投入使用的,结合了第(EU)2017/746号条例第2条第2点所定义的体外诊断医疗装置为一体的装置,均应受本条例管辖。法规(EU)2017/746的要求应适用于设备的体外诊断医疗设备部件。
8,任何在市场上投入使用或投入使用的器械,如果其成分不可分割地包含某种物质,则该物质如果单独使用,将被视为2001年指令第1条第2点所定义的药用产品/ 83 / EC,包括该指令第1条第10点中定义的源自人血液或人血浆的药品,并且具有与该设备的行为相辅相成的作用,应根据本法规进行评估和授权。
但是,如果该物质的行为是主要的行为,而不是该设备的行为,则该整体产品应受欧洲议会和理事会的指令2001/83 / EC或法规(EC)726/2004的约束( 1),如适用。在这种情况下,就设备部件的安全性和性能而言,应适用本法规附录I中规定的相关一般安全性和性能要求。
9,任何旨在管理第2001/83 / EC号指令第1条第2点所定义的药品的设备均应受本法规的约束,但不得影响该指令和(EC)726号法规的规定/ 2004关于药品。
但是,如果打算将用于管理药品的装置和药品以这样的方式投放市场,即它们形成了一个单一的整体产品,该产品专门用于给定的组合,并且不可重复使用,则该整体产品应受适用的指令2001/83 / EC或法规(EC)726/2004约束。在这种情况下,就单个整体产品的设备部件的安全性和性能而言,应适用本法规附录I中规定的相关一般安全性和性能要求。
10,任何在市场上投入使用或投入使用的,整合了与人体功能无关的人类活组织或细胞或其衍生物作为组成部分的设备,均应进行评估和授权。按照本法规。在这种情况下,应适用第2004/23 / EC号指令中规定的捐赠,采购和测试规定。
但是,如果这些组织或细胞或其衍生物的作用是主要的,而不是该设备的辅助作用,并且产品不受法规(EC)1394/2007的管辖,则该产品应受2004/23 / EC。在这种情况下,就设备部件的安全性和性能而言,应适用本法规附录I中规定的相关一般安全性和性能要求。
11,本法规是欧盟2014/30 / EU指令第2(3)条所指的特定欧盟立法。
(1)欧洲议会和理事会于2004年3月31日颁布的第(EC)726/2004号条例,规定了用于人用和兽用药品授权和监督的共同体程序,并建立了欧洲药品管理局(OJ L 136 ,2004年3月4日,第1页)。
12,在欧洲议会和理事会第2006/42 / EC号指令(1)第2条第2款(a)所指的机械设备中,如果存在与该指令相关的危害,还应满足该指令附录I规定的基本健康与安全要求,在某种程度上,这些要求比本法规附录I第II章规定的一般安全和性能要求更为具体。
13.本法规不得影响指令2013/59 / Euratom的适用。
14,本法规不得影响成员国就本法规未涵盖的方面限制使用任何特定类型的设备的权利。
15,本法规不得影响有关健康服务和医疗服务的组织,提供或筹资的国家法律,例如要求只能以医疗处方提供某些设备的要求,只能允许某些保健专业人员或医疗机构的要求的国家法律分配或使用某些设备,或者在使用这些设备时要经过专门的专业咨询。
16.只要本联盟和会员国,特别是根据《联合国基本权利宪章》第11条所保障的自由,本条例的任何规定均不得限制新闻自由或媒体的言论自由。欧盟。
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