EU AUTHORISED REPRESENTATIVE PROGRAMME

Where a manufacturer is based outside the European Community (EC), Competent Authorities must be able to contact an entity or person who is based within the EC, and acts on behalf of a manufacturer. An Authorised Representative is a natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer.

QFI operates a fully documented EU Authorised Representative service designed to meet clients’ needs when placing a product on the European Market. The service is managed by Technical Specialists from Competent Authority and industry backgrounds with relevant adverse incident and compliance enforcement action skills. Key features of the programme are as follows:

  • registration of products with the various Competent Authorities depending on which markets you intend to distribute within
  • Certificate of Appointment, containing product registration details
  • informative EU Authorised Representative Programme Members Pack, with periodic updates
  • initial technical documentation audit to ensure individual Competent Authority procedures are accommodated for your product
  • full adverse incident notification and support
  • annual review of complaints profile for notifications
  • change notification to individual Competent Authorities
  • knowledge of Competent Authority Compliance enforcement provisions.

QFI can provide short or long-term client programmes, including fixed and project pricing, providing a cost-effective service with high technical competence and focus.

Quality First International takes the role of EU Authorised Representative extremely seriously and supports and always defends clients’ interests.

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