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 is CE Marking (CE Mark)? 

An EEA/EU/EC/UK European Authorised/Authorized Representative must be designated by a non-EEA manufacturer of CE-marked medical devices.
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA & other EEA (EU/EFTA) authorities by world-leading
CE Marking Specialists based in both UK (England) & EU (Ireland)
(not affected by Brexit !). Click here to get FREE Guide Now!

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 literally 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. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.

  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 legislation, 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.
  1. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  2. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (including totally 30 EEA* countries), and
  3. CE Marking on a product permits the withdrawal of the non-conforming products by EEA customs and enforcement/vigilance authorities.

* 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 a member of EFTA, but neither an EU nor EEA member. It however is still part of the single market.

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.

Comparison of correct/real and mis-use/fake CE Conformity Marking

General principles of the CE marking

  1. The CE marking shall be affixed only by the manufacturer or his authorised representative.

  2. The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.

  3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.

  4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.

  5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

  6. Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

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  1. What is CE marking (CE mark)?
  2. The CE marking logo (Free download CE mark logo)
  3. Download of the EC Rep symbol/logo
  4. CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content
  5. What is a manufacturer? What are the responsibilities of a manufacturer?
  6. Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  7. Why is CE marking called "European passport"?
  8. Examples of EEA/EU/UK CFS/FSC: Certificate of Free Sale (Free Sales Certificate) for Medical Device
  9. Does my product need CE Marking in order to be sold/exported on/to the European Market?
  10. How to obtain CE Marking for my product?
  11. How can Wellkang Tech Consulting help me to obtain CE Marking for my product?
  12. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
  13. Complete list of all CE Marking Directives and Guidelines to Directives
  14. Complete list of all (more than 1000) Notified Bodies for CE marking
  15. Complete list of all European and/or international standards related to CE marking
  16. 85/374/eec: Directive of Liability for Defective Products (for all products)
  17. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
  18. 2000: (Proposal for a new) General Products Safety Directive (for all products)
  19. 92/59/eec: Directive of General Products Safety (for all products)
  20. 93/68/eec: "CE Marking" Directive (for all products)
  21. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
  22. Guide to Implementation of directives based on new approach & global approach (for all products)
  23. 73/23/eec: Directive of Low Voltage Electrical Equipment
  24. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
  25. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
  26. 87/404/eec: Directive of Simple Pressure Vessels
  27. 88/378/eec: Directive of Toys & Annex I, II, ... IV
  28. 89/106/eec: Directive of Construction Products
  29. 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
  30. Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
  31. Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
  32. 89/686/eec: Directive of Personal Protective Equipment (PPE)
  33. 90/384/eec: Directive of Non-automatic Weighing Instruments
  34. 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
  35. 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
  36. 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
  37. 93/15/eec: Directive of Explosives for Civil Uses
  38. 93/42/eec: Directive of Medical Devices
  39. 2001 Guidelines for Classification of Medical Devices
  40. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
  41. 90/385/eec: Directive of Active Implantable Medical Devices
  42. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
  43. Guidelines to Medical Devices Vigilance System
  44. List of Harmonised (European) Standards for Medical Devices
  45. List of Notified Bodies for Medical Devices Directive
  46. 93/65/eec: Directive of Air Traffic Management Equipment & Systems
  47. 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
  48. Guidelines to directive 94/9/ec (Atex)
  49. 94/25/ec: Directive of Recreational Craft
  50. 95/16/ec: Directive of Lifts
  51. 96/48/ec: Directive of Trans-European High-speed Rail System
  52. 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
  53. 96/98/ec: Directive of Marine Equipment
  54. 98/37/ec: Directive of Machinery
  55. 2000: Comments on Directive of Machinery 98/37/ec
  56. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  57. 2000/9/ec: Directive of Cableway Installations to Carry Persons
  58. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors

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