Article 5 Placing on the market and putting into service
1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
4. Devices that are manufactured and used within health institutions shall be considered as having been put into service.
5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
(a) the devices are not transferred to another legal entity,
(b) manufacture and use of the devices occur under appropriate quality management systems,
(c) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
(d) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
(e) the health institution draws up a declaration which it shall make publicly available, including:
(i) the name and address of the manufacturing health institution;
(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
(f) the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manu facturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
(g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
(h) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the exa mination procedure referred to in Article 114(3).
Article 6 Distance sales
1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.
4. A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
Article 7 Claims
► C1 In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and ◄ figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
1,只有在按照预期目的妥善提供,正确安装,维护和使用的设备符合本法规的情况下,才能将其投放市场或投入使用。
2.考虑到设备的预期用途,设备应满足适用于该设备的附件I所列的一般安全和性能要求。
3符合一般安全和性能要求的证明应包括根据第61条进行的临床评估。
4.在卫生机构内制造和使用的设备应视为已投入使用。
5,除附件一中规定的有关一般安全和性能要求外,本规则的要求不适用于仅在国际电联设立的卫生机构内制造和使用的设备,但必须满足以下所有条件遇到:
(a)这些设备未转移到另一个法人实体,
(b)在适当的质量管理体系下进行设备的制造和使用,
(c)卫生机构在其文件中证明无法满足目标患者群体的特定需求,或者无法通过市场上可用的等效设备以适当的性能水平满足目标患者群体的特定需求,
(d)卫生机构应要求向其主管当局提供有关使用此类设备的信息,其中应包括其制造,修改和使用的理由;
(e)卫生机构起草一份声明,将其公开发布,包括:
(i)制造卫生机构的名称和地址;
(ii)识别设备所需的细节;
(iii)声明该设备符合本规章附件I规定的一般安全和性能要求,并在适用的情况下,以合理的理由说明未完全满足要求的信息,
(f)卫生机构起草的文件可以使您对设备的制造设施,制造过程,设备的设计和性能数据有所了解,包括预期的目的,并且要足够详细,以使主管人员能够有权确定满足本规章附件I规定的一般安全和性能要求;
(g)卫生机构采取了所有必要措施,以确保按照(f)点所述的文件制造所有器械,并且
(h)卫生机构审查从临床使用器械获得的经验,并采取所有必要的纠正措施。
会员国可要求此类医疗机构向主管当局提交有关在其领土上制造和使用的此类设备的任何进一步的有关信息。会员国应保留限制制造和使用任何特定类型此类设备的权利,并应被允许检查卫生机构的活动。
本款不适用于以工业规模制造的设备。
6.为了确保附件一的统一适用,委员会可在必要的范围内通过实施法案,以解决歧义解释和实际适用问题。那些实施行为应按照第114条第3款所述的审查程序通过。
1,通过指令(EU)2015/1535第1(1)条(b)定义的信息社会服务向联盟中建立的自然人或法人提供的设备应遵守本法规。
2.在不影响有关医学专业工作的国家法律的前提下,一种不投放市场但在商业活动中使用的设备,以提供付费或免费使用作为诊断手段或通过指令(EU)2015/1535第1(1)条(b)定义的信息社会服务或通过其他直接或通过中介与建立的自然人或法人的通信方式提供的治疗服务在联盟中应遵守本法规。
3.应主管当局的要求,提供根据第1款提供设备或根据第2款提供服务的任何自然人或法人应提供有关设备的欧盟合格声明的副本。
4.成员国可以基于保护公共健康的理由,要求其根据指令(EU)2015/1535第1(1)条(b)定义的信息社会服务提供商停止活动。
►C1在设备的标签,使用说明,提供,投入使用和广告中,应禁止使用可能会误导用户或患者的文字,名称,商标,图片和◄图形或其他标志。通过以下方式考虑设备的预期用途,安全性和性能:
(a)将设备不具备的功能和特性分配给该设备;
(b)对设备没有的治疗或诊断,功能或特性造成错误的印象;
(c)没有按照预期用途告知用户或患者有关使用该设备的潜在风险;
(d)建议将设备的用途指定为构成合格评定的预期目的的一部分以外的用途。
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