European Authorised Representative

A European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the European Economic Area (EEA, including EU & EFTA), who, explicitly designated by a non-European manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

  • For the purposes of New Approach directives the Authorised/Authorized Representative must be established inside the Community.
  • The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.
  • Commercial representatives of the manufacturer (such as importer, authorized/authorised agent, authorized/authorised distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.
  • The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.

CTI-CEM can provide EU Authorized Representative service under Medical Devise Directive to ensure an easy access to EU market. To help us providing the service to you, we only need you to:

  • Authorize the Company to be your EA representative to carry out the responsibilities and obligations as required by the directive by signing the Authorization Agreement with us.
  • Provide the technical documentation as required by the Directive

Please contact us for a further action for you putting your product(s) to the EU market