Article 13 General obligations of importers
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. In order to place a device on the market, importers shall verify that:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufac turer;
(c) the device is labelled in accordance with this Regulation and accom panied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.
5. Importers shall ensure that, while a device is under their respon sibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.
9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
1.进口者应仅将符合本法规的设备投放到联盟市场。
2.为了将设备投放市场,进口商应核实:
(a)该设备已经过CE标记,并且已经起草了该设备的欧盟合格声明;
(b)确定了制造商,并且制造商已经指定了根据第11条指定的授权代表;
(c)该设备已按照本法规进行了标记,并附有所需的使用说明;
(d)如果适用,制造商已根据第27条分配了UDI。
进口商认为或有理由认为设备不符合本法规的要求时,不得将设备投放市场,直到符合要求,并应通知制造商和制造商的授权代表。如果进口商认为或有理由认为该设备存在严重风险或是伪造的设备,则还应通知该进口商所在成员国的主管当局。
3,进口者应在设备或其包装上或设备随附的文件中注明其名称,注册商标名称或注册商标,其注册营业地点以及可以联系其的地址,以便其位置被建立。他们应确保任何附加标签都不会遮盖制造商提供的标签上的任何信息。
4.进口商应根据第29条核实设备已在电子系统中注册。进口商应根据第31条在注册中添加其详细信息。
5,进口商应确保设备在其责任范围内,其存储或运输条件不会危及其对附件I所列一般安全和性能要求的遵守,并应遵守制造商规定的条件(如适用)。
6,进口商应保存投诉,不合格设备以及召回和撤回的记录,并向制造商,授权代表和分销商提供他们要求的任何信息,以使他们能够调查投诉。
7,进口者认为或有理由相信其投放市场的设备不符合本法规的规定,应立即通知制造商及其授权代表。进口商应与制造商,制造商的授权代表和主管当局合作,以确保采取必要的纠正措施以使该设备合格,撤回或召回。如果设备存在严重风险,他们还应立即通知提供设备的成员国的主管当局,以及(如适用)根据有关设备第56条签发证书的指定机构,尤其是详细说明违规行为和采取的任何纠正措施。
8.收到医疗保健专业人员,患者或用户对与投放市场的设备有关的可疑事件的投诉或报告的进口商,应立即将此信息转发给制造商及其授权的代表。
9,进口商应在第10条第8款所述的期间内,保留欧盟符合性声明的副本,并酌情保留根据第56条签发的任何相关证书的副本,包括任何修正和补充。
10.进口商应在主管当局的要求下与主管当局合作,以采取任何措施消除或(如果不可能)减轻他们投放市场的设备所带来的风险。进口商应进口商在其注册营业地所在成员国的主管当局的要求,免费提供该设备的样品,或者在不可行的情况下,准许使用该设备。
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