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…) [...]

European Authorized Representative



What is a European Authorized Representative (E.A.R.)?

An Authorized Representative is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of this Directive.

What are the duties of an E.A.R?

The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:

  • Providing a registered address within the European Union
  • Keeping all technical documentation available for inspection by the European Authorities
  • Completing notifications to European Authorities
  • Completing any registrations to national databases
  • Taking care of any incident reporting
  • Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
  • Safeguarding and ensuring compliance with constant regulatory updates
  • Consulting on European Regulations

| Home | Contact Us | Get a Quote |


Was it useful? Share it!