What is EU Authorized Representative?
EU Authorized Representative means any natural or legal person established within the Union who has obtained and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer’s behalf concerning specified tasks given in MDR 2017/745.
如果制造商位于欧盟之外，或者制造商在欧盟没有注册的营业地点，则在这种情况下，制造商可以聘请欧盟的代表，称为授权的欧洲代表。
- 188金宝搏网站靠谱吗全球运作，，，，our team knows regulatory process of European countries,作为一个CE Mark医疗设备consultant we help you in process制作technical file for your product.如果你想任何监管指导contact us或者你也可以whatsappus您的详细信息我们将连接您back.
欧盟授权代表也称为Cerep，Euar，Eu Rep，EC Rep和Ear。
制造商和授权代表必须在启动任何活动之前签署授权/协议。The mandate should in reality outline the roles and obligations of the both parties and the designation shall represent the authorised representative’s mandate, it will be valid only when established in writing through the authorised representative and will be effective at the least for all devices of the same regular device group.
欧盟授权代表应履行其与制造商之间商定的授权中规定的职责。授权代表应应要求向会员国主管当局提供任务副本。我们已经讨论了欧盟MDR在我们以前的文章中，您可以将其引用以获取更多详细信息。
欧盟授权代表职责：
授权中明确定义了以下任务/职责，欧洲授权代表也需要执行相同的要求。
- 欧盟授权代表应验证欧盟的合格声明，其他技术文件，并在适用的情况下，制造商已执行适当的合格评估程序。
- 欧盟授权代表应维护技术文件的副本，欧盟的合规宣言，如果适用，则应根据符合条件证明的证书（包括任何修正案和补品）的相关证书的副本，以权威的权威机构的权威机构签发。在市场上制造商提供的最后一次设备后，将10年的时间和可植入设备的文档保存15年。
- 遵守注册义务并验证制造商是否符合第27条（唯一的设备识别）和第29条（设备注册）的注册义务
- If the Component authority of member state requested the Set of Technical documentation, then Authorized representative is responsible to provide the necessary documents to demonstrate the conformity of devices, in official union language determined by member state.
- 向制造商转发会员国的主管机构的任何请求，在该要求中，授权代表拥有其样品的注册业务工作场所，或访问设备，并确认主管当局可以接收样品或可以访问该设备。
- 欧盟授权代表应与主管当局合作就取消的任何预防或纠正措施，或者，如果这并不总是可行的，请减轻设备带来的风险；（立即将医疗保健专业人员，患者和用户的投诉和报告通知制造商，了解与已指定的设备有关的可疑事件。）
- 欧盟授权代表可能终端te the mandate if the manufacturer acts contrary to its obligations under this Regulation.
If the European authorized representative terminates the Mandate, then they Immediately need to notify the Competent Authority of the member state along with the reason for termination.
Where the manufacturer is not established in a Member State and has not complied with the obligations given in article 10 (General Obligations of Manufacturer), the EU authorized representative shall be legally liable for faulty devices on the same basis as, and jointly and severally with, the manufacturer.
欧盟授权代表( EC REP ) have greater duties and take on drastically more risk and liabilities, consequently you can expect your representative to scrutinize your documentation extra very well.
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