What is an Authorized Representative?

On medical devices sold in the European Union and bearing the CE mark, the European directives require that a European address be affixed on the devices and/or labels.

Manufacturers having no address in the European Union or willing to keep independent from their distributors need an " authorized representative " for this purpose.

Mediprotect offers the services of authorized representative to medical devices manufacturers throughout the world.

The tasks of the authorized representative will include e.g.:

• Having his coordinates on the device and/or labels
  
• Registration of the product (if belonging to Class I of the 93/42/EEC directive) to his national competent authorities ("Health Inspection" in Belgium)
  
• Reporting quality incidents to the Competent authorities and being the "link" between the authorities and the manufacturer outside Europe.
  

Mediprotect also offers the following services as authorized representative:

• Use of our independent address in Brussels
  
• Representation to the notified bodies and competent authorities
  
• Handling incidents and reports, using database tools where needed
  
• Product recall 
  
• Advising on correct use of the CE mark
  
• Regular updates on CE issues

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Last Update: November 30th 2003