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What Is Why Need Difference Why Wellkang Questions & Answers FREE guide on CE marking of medical devices MDD/IVDD
medical devices EU/EC European Authorised/Authorized Representative

As of 21 March 2010, a Single EEA/EU/EC European Authorised/Authorized Representative must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
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Why is the EU/EC Authorised/Authorized Representative different from the importer/distributors ?

  • Why do you need a European Authorised/Authorized Representative?
  • Why must the manufactures of medical devices appoint a European Authorised/Authorized Representative?
  • Why is the EU/EC Authorised/Authorized Representative different from the importer/distributors ?
  • Why choose Wellkang?
  • How can Wellkang help you?
  • What are included in Wellkangs EU/EC Authorised/Authorized Representative Service?
  • 11 benefits by appointing Wellkang as your EU/EC Authorised/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?


  • Why is the Authorized Representative different from the importer/distributor ?

    An Authorized (Authorised) Representative is the one who will represent the manufacturer to deal with the CE Marking vigilance authorities from the EEA (28 EU + 3 EFTA) Member States. This is somehow similar to that you may need a lawyer representing you in the court.

    The Authorised Representative usually does NOT involve itself in the distribution and/or sales of the products as the importers/distributors usually do.

    Most of the importers/distributors are skilled in marketing and sales, but not familiar with the complicated CE Marking issues.

    A non-EEA manufacturer needs only one Authorized Representative in the entire European Union whereas may have many distributors and/or sales agents.

    It is required by the EEA legislation that a non-EEA manufacturer must print its EEA Authorised Representative´s name, address & contacting details on the packaging/labeling of the product(s) sold onto the single EEA (28 EU + 3 EFTA) market. The authorities from any of the EEA (28 EU + 3 EFTA) Member States may call the Authorized Representative up for CE Marking vigilance at any time and the Authorized Representative must respond immediately and properly within the permitted time.


    The European Economic Area (EEA):

    The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

    Switzerland is neither an EU nor EEA member but is part of the single market.



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


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