Authorized Representative for Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC

QNET offers Authorized Representative services for devices of all risk classes in Europe. This service 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 the directives and regulations and contact you only when there are issues that deserve your attention.
  • Interfacing on your behalf between Competent Authorities, Notified Bodies 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.
  • Co-Signing your Declaration of Conformity.

Click Here for an Authorized Representative proposal form

Frequently Asked Questions about the role of the European Authorized Representative.

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Click Here for an Authorized Representative proposal form

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