Authorized Representative in EU

What is a European (EU/EC) Authorised/Authorized Representative?

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.



FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices

• What is a European (EU/EC) Authorised/Authorized Representative?
• Why do you need a European (EU/EC) Authorised/Authorized Representative?
• Why must the manufactures of medical devices appoint a European (EU/EC) Authorised/Authorized Representative?
• Why is the Authorized EU/EC Representative different from the importer/distributors ?
• Why choose Wellkang?
• How can Wellkang help you?
• What are included in Wellkangs EU/EC Authorized Representative Service?
• 11 benefits by appointing Wellkang as your EU/EC Authorized Representative?
• 3 unique benefits offered by Wellkang that are not available from others?
• How much does it cost? Competitive Price List!
• How to contact Wellkang?
  
  
• Is my product a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVD)?
  
• How to classify Medical Devices (MD)?
• Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Why must inform/notify/register with the Competent Authority?
  
• When to inform/notify/register with the Competent Authority?
  
• Who should apply/register with the Competent Authority?
  
• Changes to registered details?
  
• Class I (including Is & Im) medical devices CE Marking procedures
  
• Medical device CE Marking procedures
  
• Steps to obtain CE Marking for your medical devices
  
• Legal basis for medical devices
  
• Cost and fees for the CE Marking of medical devices
• Click here to contact us for a quotation

About CE Marking:

• What is CE marking?
  
• The CE marking logo
  
• What is a manufacturer?
  
• Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  
• Why is CE marking called "European passport"?
  
• Does my product need CE Marking for the European Market?
  
• How to obtain CE Marking for my product?
  
• Where can I find CE marking related publications & guidelines?
  
• How to distinguish EU directives?
  
• Where can I find CE marking testing labs nearest to my location
  

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