Register/Notify your MDD-Medical Devices and
IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking
Specialists based in London/UK. Click here to get FREE Guide Now!
 In EnglishIn FrenchIn PortugueseIn SpanishIn Chinese
What is CE Marking ?
Why is it called
How does CEM affect export to Europe?
In which countries is CE Marking required?
How many directives are there ?
What products need CEM ?
Which directive applys ?
How to obtain CE Marking ?
Who is going to enforce CEM ?
How can Wellkang help you ?
Why do I need a Representative in Europe ?
Online inquiry form
Contact us
link exchange
Member LogIn
100% Satisfication

we accept Visa, MasterCard, Eurocard, DinersClub, AmericanExpress, JCB, etc

CE Marking

get free CCC mark guide

Like this site? Tell Your Friends

Why is CE Marking
 called the "Passport to Europe" ?

Why is CE Marking called-
the "Passport to Europe" for non-EU products?

The European Union's 'New Approach directives' are mandatory on all member countries to enact through national legislation.

This legislation requires manufacturers to display CE Marking on their product, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offence to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying CE Marking.

CE Marking is one important measure that the EU has adopted to establish the single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU. This may eventually lead to the free movement of goods throughout Europe as more and more european countries are expected to join the EU. The European Commission thus refers to the CE Marking as a "Passport" which allows products to be freely circulated within the EU single market.
Often, consumers will consider CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality which other products may lack. CE Marking is thus for many consumers a "Symbol of Quality." Being a manufacturer exporting to EU, if you have not got your products fixed with CE Marking, it is now time to invest in it. A CE Marking on your product will be more valuable than millions of dollars spent on TV advertising. Nowadays, it is not unusual to see some high-quality, even known brand, products have to appear in Second-hand Stores (which sells used products) or on street-vendor's Stands. Why? lack CE Marking!

back to top of the page back to top of this page

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:-

  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

price list   order now !

| home/first page | back to where you were | back one page | top of this page | next page |