Authorized Representative

Qarad can act as your European Authorized Representative (EC REP). This allows you to keep compliance separate from commercial interests and to remain independent from your distributors in regulatory issues.

 

Who needs an Authorized Representative?
Symbol European Authorized Representative     All manufacturers who do not have a registered place of business in a Member State of the EU or EFTA, nor in Switzerland or Turkey, and who are manufacturing:

  • In vitro diagnostic medical devices (all classes)
  • Medical devices (all classes)
  • Active implantable medical devices

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What is the role of an Authorized Representative?

The roles and responsibilities of the Authorized Representative or EC REP are described in several places of the European Directives and Regulations. Click here for a short overview.

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    Why appoint Qarad as your Authorized Representative?

    Qarad is an independent organization. This keeps your commercial and regulatory interests in Europe separated. It allows you to give all your European distributors and O.E.M. customers independent regulatory support. It is not recommended to appoint a distributor as your Authorized Representative.

    A good EC REP is more than a mailbox. He guides you through the regulations, assists you in the case of regulatory action against your company and communicates to the competent authorities. This requires a unique mix of regulatory, technical-scientific and communication skills.

    Qarad’s team has the adequate experience and qualities.

    Qarad is a member of the European Association of Authorized Representatives and subscribes to its Code of Conduct.

    European Association of Authorised Representatives (EAAR)

    Qarad as your Authorized Representative: practical

    A contract between your company and Qarad will be established, outlining mutual tasks and responsibilities. An annual fee, covering Authorized Representative services, will be charged.

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    Contact us for a price quotation.


    Qarad as your EC REP

    Contact us to learn more about our Authorized Representative Services!
    Authorized Representative Services Flyer
    Authorized Representative Services Flyer
    Download our Flyer to learn more about the advantages of having Qarad as your Authorized Representative
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    XDx, Inc.
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