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European Authorized Representative for Regulatory Affairs





QNET offers Authorized Representative services for products of all risk class devices in Europe. This service also includes:

  • QNET B.V. as the name you may print on your CE-marked devices and related printed materials i.e. labels, instructions for use, inserts, manuals, websites.

  • Registering of your CE-marked devices with the appropriate Competent Authorities and holding your technical file available as required.

  • Monitoring changes to directives and regulations and contact you only when there are issues that deserve your attention.
    For example: Click here for What Manufacturers need to know about the EU Battery Directive.
  • Interfacing on your behalf between Competent Authorities, Notified Body and your distributors or end-users.

  • Performing an annual review of your technical file content with a reminder to update or change existing documentation.

  • Protecting your documentation's confidentiality by contractually agreeing to show them to the Competent Authorities only.

  • Notification of the Competent Authorities of serious incidents.

  • Co-signing your Declaration of Conformity.

  • On-site visits.

  • Visit our website www.ce-authorizedrepresentative.eu .


    — WWW.CE-Mark.com



    03/01/07