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【欧盟】欧盟医疗器械数据库EUDAMED-UDI 器械唯一标识模块开通方法
  • 【欧盟】欧盟医疗器械数据库EUDAMED-UDI 器械唯一标识模块开通方法
  • 【欧盟】欧盟医疗器械数据库EUDAMED-UDI 器械唯一标识模块开通方法
  • 【欧盟】欧盟医疗器械数据库EUDAMED-UDI 器械唯一标识模块开通方法

【欧盟】欧盟医疗器械数据库EUDAMED-UDI 器械唯一标识模块开通方法

EUDAMED-医疗器械产品UDI功能,BASID-UDI, UDI-DI模块如何开通
EUDAMED - The UDI/Devices and NBs Certificates modules are open.
EUDAMED-医疗器械产品UDI功能,Notify Body证书模块正式开放

 
Active from 2021-10-04 to 2021-12-01
The UDI/Devices and NBs Certificates modules are open.

 
The system is available again and the UDI/Devices and NBs Certificates modules are open. IMPORTANT INFORMATIO FOR THE USERS • The default profile for the new modules is the lowest one, i.e. viewer. • To request to change/upgrade your profile into proposer or confirmer, click on your name in the top right hand side to reach the My Account page. There you will see a link next to your profiles called "Request for change". Click on this link and follow the steps to select the profiles for the module you need. Your LAA/LUA will need to approve this request before these features will be available. • A LAA cannot approve their own requests so for any actor with only ONE user, a second user with a LUA or LAA profile will be needed to approve any profile upgrade requests


步骤:


 1.  点击用户名:

To request to change/upgrade your profile into proposer or confirmer, click on your name in the top right-hand side to reach the My Account page






 2. 点击 “Request for Change"

There you will see a link next to your profiles called "Request for change". 






  3. 填写名,姓,职位,保存并进行下一步

Click on this link and follow the steps to select the profiles for the module you need.





 4. 选择UDI/DIVICE功能,申请者,批准者,选择权限有效期至XXXX年XX月XX日,提交



Remark: 备注:
A LAA cannot approve their own requests so for any actor with only ONE user, a second user with a LUA or LAA profile will be needed to approve any profile upgrade requests.
必需有两个账工户,才能批准此申请,对于只有一个EUDAMED账户的企业,自己不能批准自己.




   5. 登录另一个账户,批准:



   




   6. 就可以建自己的BASID-UDI, UDI-DI了,大功告成!




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Disclaimer 作者声明
The information on this page is valid and current as of october 2021. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. 
本页信息自 2021 年 10 月有效且最新。立法和条例规定须经所指国家管理当局的修改和更新。