Authorised Representative

What is an European Authorised Representative?

The European Authorised Representative is a natural person or a legal entity which acts on behalf of the manufacturer within the CE legislation. Regardless if the manufacturer is situated within or outside the European Union, he or she can appoint an Authorised Representative to carry out certain tasks required within the applicable CE legislation. Manufacturer of medical devices are obliged to appoint an authorised representative. The Authorised Representative must be established in the European Union.

Manufacturer benefit greatly by appointing an Authorised Representative. The Authorised Representative can be appointed to perform tasks such as: 

  • affix the CE marking (and where relevant other markings) and the notified body’s number to the product,
  • draw up and sign the EC Declaration of Conformity,
  • keep the Declaration and the Technical Documentation at the disposal of national surveillance authorities and cooperate with them at their request,
  • upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product
  • cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

What can we offer?

Certification Company can formally be appointed as the Authorised Representative for your product(s). With our extensive knowledge and expertise in the field of European (CE) legislation, Certification Company will take the responsibility and obligation for CE certification, ensuring that you can focus on your core business.   

Certification Company offers a modern and flexible form of Authorised Representation services: 

  • The conditions of our services are laid down in an understandable agreement
  • Our services are terminable per quarter
  • We provides a non-disclosure agreement free of charge to ensure that the confidentiality of your information is ensured 

Your benefits if you appoint Certification Company as the Authorised Representative: 

  • Complete package of Authorised Representation services and obligations
  • Act as liaison and primary contact point for all national competent authorities in the European Union
  • Official authorisation to place Certification Company and its trademark on the product and documentation as the authorised representative
  • Non-disclosure agreement to guarantee confidentiality
  • Clustering possibilities for similar products
  • Terminable agreement per quarter
  • Discount possibilities for long-term agreements

What are the costs involved for European Authorised Representative?

The fee structure consists of: 

  • Retainer fee per quarter or per annum as requested by applicant
  • Guaranteed no unexpected costs 

Are you interested in our Authorised representation services? Contact us directly at +31 (0)36 202 4012 or fill in our contact form to request a quotation or advice free of charge. One of our experts will contact you within 24 hours.

 

 

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