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

^

What is the role of an Authorized Representative?

The role and responsibilities of the Authorized Representative or EC REP are described in several places of the European Directives, for example:

 

 Role and responsibilities
IVDD
98/79/EC 
MDD
93/42/EEC
AIMD
90/385/EEC
 Acts and may be addressed by authorities in the EU instead of the
 manufacturer with regard to the latter's obligations under the Directive
Art. 1.2
Art. 1.2
Art. 1.2
 Notifies the Competent Authorities of the address of the manufacturer
Art. 10
Art. 14
Art. 10a
 Notifies the Competent Authorities of the manufacturer's products
Art. 10
 Art. 14
Art. 10a
 Notifies the Competent Authorities of changes to the products
Art. 10
Art. 14
Art. 10a
 Notifies the Competent Authorities of performance characteristics (Annex II
 IVD products and devices of self-testing only)
Art. 10
   
 Draws up the statement concerning devices for performance evaluation Annex VIII

 May be contacted by the Commission in the context of the Safeguard Clause
 Art. 8
 Art. 8
 
 May initiate Conformity Assessment Procedures
Art. 9.6
Art. 11.8
Art. 9.3
 Must make technical documentation available to authorities on their request
Art. 9.7
Annex III.7
Annex II.6.1
 Is informed by Competent Authorities about incidents
Art. 11
Art. 10
Art. 8
 May be the interface between Notified Body and manufacturer
Art. 15 Art. 16
Art. 11
 In the case of a wrongly affixed CE mark, the Authorized Representative
 must bring the infringement to an end
Art. 17
Art. 18
Art. 13a
 For devices intended for clinical investigations, the Authorized Representative 
 follows the required procedure and notifies the Competent Authorities

Art. 15.1
Art. 10.1

    ^

    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.

    ^
    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
    « Everybody in Brisbane was very pleased with the work you had done. They had an excellent impression of you, and of what you did. My colleague told me it was the best recommendation he had ever had. You can’t ask for more than that, but I also expected no less. »
    James Jones
    XDx, Inc.