Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
News

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
News

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

欧盟授权代表

什么是欧盟授权代表(E.A.R.)?

授权代表指的是由制造商指定以其名义行事的欧盟共同体内之自然人或法人。根据欧盟指令的要求,此代表人有可能由共同体内的当局或机构指定,而非制造商本身。

E.A.R.的责任是?

欧盟授权代表的角色很多样而且很有挑战性。主要的责任包括,但不限于下列各项:

  • 提供位于欧盟境内的注册地址
  • 保管所有技术文件以供欧州当局检视
  • 完成提交给欧州当局的登录
  • 完成任何国家数据库的注册
  • 处理任何事故报告
  • 代表制造商跟欧洲委员会、当局以及公告机构应对
  • 确保安全性,并确保产品符合经常性的法规更新的要求
  • 提供欧洲规章的咨询

 

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