CE知识分享欧盟代理人 医疗器械欧盟授权代表European Authorised Representative 殴代办理

欧盟代理人全称为欧盟授权代表(European Authorised Representative)是指由位于欧洲经济区EEA(包括EU与EFTA)境外的制造商明确指定的一个自然人或法人。该自然人或法人可代表EEA境外的制造商履行欧盟相关的指令和法律对该制造商所要求的特定的职责。

请在接下来的7天内采取以下步骤回应上述问题：

1.提交以下文件：

a.符合性声明。 这必须由欧盟制造商发布，或者如果产品制造商不在欧盟，则是欧盟的进口商。

b.测试报告以备份符合性声明

c.所有方面的产品和包装图像，显示1.欧盟制造商或进口商的地址2. CE标志和3.和型号

d.使用说明

e.由STA办理

2.填写以下产品安全问卷。 调查问卷旨在解决客户提出的安全问题。 有关您可能没有的详细信息，请与产品制造商联系。

亚马逊德国站，英国站要求客户提供欧盟责任人信息，目前新邮件回复如下：

Dear Seller,

The Product Safety department was informed of a safety incident with a product sold by you.

Your product appears to be an Electronic.

Please respond to the above concern by taking the following steps within the next 7 days:

1. Submit the following documentation:

a. Declaration of Conformity. This must be issued by the EU based manufacturer or, if the product's manufacturer is not based in the EU, the EU based importer.

b. Test Reports to back up the Declaration of Conformity

c. Images of the product and packaging from all sides, showing 1. address of EU based manufacturer or importer 2. CE marking and 3. brand and model number

d. Instructions for use

e. Handled by Shenzhen STA Testing Co., Ltd

2. C.o.mplete the below Product Safety Questionnaire. The questionnaire is geared towards addressing the safety concern that the customer has brought up. Please contact the manufacturer of the product for details you might not have.

亲爱的卖家，

产品安全部门获悉您销售的产品发生的安全事故。

您的产品似乎是电子产品。