Authorised Representative - CE Marking

An (EU/EC) European Authorised/Authorized Representative is a natural or legal person established in the EU who, explicitly designated by a non-Euroepan manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

• For the purposes of New Approach directives the Authorised/Authorized Representative must be established inside the Community.
  
  
• The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.
  
  
• Commercial representatives of the manufacturer (such as importer, authorized/authorised agent, authorized/authorised distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.
  
  
• The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.

The delegation of tasks from the manufacturer to the Authorised/Authorized Representative must be explicit and should take place in writing, in particular to define the contents of the tasks and the limits of the representative’s powers. The tasks that may be delegated to the Authorised/Authorized Representative according to the directives are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the setting up of a technical documentation, unless otherwise provided for. Further, an EU/EC Authorised/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.



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FAQs

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

Why do we need to select an Authorized Representative if we are located outside Europe?
What are our options?

How do we choose between an agent, distributor and an independent Authorized Representative?

Do independent Authorized Representatives sell medical devices in Europe?

How do we select an Authorized Representative?

Which of the Authorized Representative's essential duties are listed in the Medical Device Directive 93/42/EEC and what should we ask for in addition?

Why should the Authorized Representative sign the manufacturer's Declaration of Conformity?

What does the Authorized Representative expect from us, the manufacturer?

Why do we need to place a partial technical file with our Authorized Representative in Europe?
How do we keep this technical file up to date?

Is all the information we place with the Authorized Representative confidential?
What are the Authorized Representative's obligations and liabilities if the manufacturer's devices are not in compliance?

Is product liability covered by the Authorized Representative agreement?
Why do Authorized Representative agreements include a penalty clause in case of contractual violation by the manufacturer?

If we cancel our Authorized Representative agreement do all duties stop immediately?

For the answers to these questions click here.

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