Contact Us
Introduction Services Fees Medical Devices Other Products Questions & Answers Order Now
questions & answers

What
 is CE Marking (CE Mark)? 

Want to increase your export? Let top import/export consultants help you !!! visit the website shown on the banner to learn more ->>

What is CE Marking (CE Mark)?

CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literaturely means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term.

  1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives.*
    2. *Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
    CEN stands for European Committee for Standardization.
    CENELEC stands for European Committee for Electrotechnical Standardization.
  2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 30 countries), and
  4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

Along with more directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business.


  • Why do you need a representative in Europe?
  • Why must the manufactures of medical devices appoint a EU Authorized Representative?
  • Why is the Authorized Representative different from the importer/distributor ?
  • Why choose Wellkang?
  • How can Wellkang help you?
  • What are included in Wellkangs EU Authorized Representative Service?
  • 11 benefits by appointing Wellkang as your EU Authorized Representative?
  • 3 unique benefits offered by Wellkang that are not available from others?
  • Is Wellkang Group part of the U.S. government or EU authorities?
  • How much does it cost? Competitive Price List!
  • How to contact Wellkang?


    • About Medical Devices
    About CE Marking:

    Wellkang® Group is your one-stop global solution provider!
    Sell to Europe? Here are your solutions: www.CE-marking.com  www.Auth-Rep.com  www.WEEEregistration.com
    Sell to US? Here are your solutions: www.FDA-Registration.com  www.FDAagent.us  www.510k.org
    Sell to China? Here are your solutions: www.CCC-mark.com  www.CCC-mark.cn
    Last updated on