This website is the property of Wellkang® Tech Consulting, an international B2B regulatory consulting group. Wellkang is proud to present at this website with world's most comprehensive multi-lingual information guide on CE Marking.

CE Marking (CE-Marking), also known unofficially as "CE mark" or "EC Mark", as shown on the top of this page, is a mandatory mark for many (estimatively around 70%) of the products sold on the EFTA plus European Union (EU) market (total 28 countries) and it is often referred as the "Trade Passport to Europe" for non-EU products.

EU legislation, e.g. EU directive concerning Liability for Defective Products, make EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them. The liability claims in a law suit can be as high as 70 millions EUROs.

CE Marking may be achieved through several modules. One of the most practical ways, which is preferred by many EU importers who are neither specialized in the complicated CE Marking process nor willing to take risk, is that the manufacturer designates an Authorized Representative in the EU member states who will handle the CE Mark approval, CE testing issues and ensure to meet the CE mark requirements, meanwhile the importers and/or distributors focus on the marketing and sales of the products.

The manufacturer may need only ONE Authorized Representative in EU whereas may have many importers and/or distributors. The Authorized Representative may in some cases register the product(s) in the EU member states and thus obtain a Certificate of Registration. The Product Certificate of Registration for CE Marking obtained from one EU member state is valid for the entire EFTA plus EU market, i.e. 30 countries.

In general, CE Marking is most probably required if you want to sell, to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states, the following 22 groups of products:

appliances burning gaseous fuels, cableway installations to carry persons, construction products, electrical equipment, equipment and protective systems for explosive atmospheres, explosives for civil uses, hot water boilers, household refrigerators & freezers, lift, machinery, marine equipment, measuring instruments, medical devices, active implantable medical devices, in vitro diagnostic medical devices, non-automatic weighing equipment, personal protective equipment, pressure equipment, simple pressure vessels, recreational craft, radio equipment & telecommunications terminal equipment, toys and trans-European conventional rail system.

Click here >> you can find the definition of every group of products.

We are trying our best efforts to maintain this site as a one-stop CE Marking (CE Mark) information source. Hope you will find everything you need to know about CE marking. Let world leading Wellkang Tech Consulting group help you in (CE Marking) CE mark approval, ce testing for Medical Devices (MDD), Personal Protective Equipment (PPE), Low Voltage Electrical Equipment (LVD), Electromagnetic Compatibility (EMC), Machinery, Toys, etc. 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. Required content for the CE marking EC Declaration of Conformity
   
4. Does my product need CE Marking in order to be sold/exported on/to the European Market?
5. How to obtain CE Marking for my product?
6. How can Wellkang Tech Consulting help me to obtain CE Marking for my product?
7. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
8. Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish.
9. Complete list of all CE Marking Directives and Guidelines to Directives
10. Complete list of all (more than 1000) Notified Bodies for CE marking
11. Complete list of all European and/or international standards related to CE marking
12. 85/374/eec: Directive of Liability for Defective Products (for all products)
13. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
14. 2000: (Proposal for a new) General Products Safety Directive (for all products)
15. 92/59/eec: Directive of General Products Safety (for all products)
16. 93/68/eec: "CE Marking" Directive (for all products)
17. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
18. Guide to Implementation of directives based on new approach & global approach (for all products)
19. 73/23/eec: Directive of Low Voltage Electrical Equipment
20. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
21. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
22. 87/404/eec: Directive of Simple Pressure Vessels
23. 88/378/eec: Directive of Toys & Annex I, II, ... IV
24. 2001 Framework of implementation of 88/378/eec: Directive of Toys
25. 89/106/eec: Directive of Construction Products
26. 2001 Guidance to 89/106/eec Directive of Construction Products
27. 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
28. Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
29. Technical-Aspects relating Directive of Electromagnetic Compatibility (EMC) 89/336/eec
30. Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
31. 89/686/eec: Directive of Personal Protective Equipment (PPE)
32. Useful Facts relating to Directive (PPE) 89/686/eec
33. 2001 Framework of implementation of (PPE) Directive 89/686/eec
34. 90/384/eec: Directive of Non-automatic Weighing Instruments
35. 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
36. 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
37. 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
38. 93/15/eec: Directive of Explosives for Civil Uses
39. 93/42/eec: Directive of Medical Devices
40. 2001 Guidelines for Classification of Medical Devices
41. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
42. 90/385/eec: Directive of Active Implantable Medical Devices
43. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
44. Guidelines to Medical Devices Vigilance System
45. List of Harmonised (European) Standards for Medical Devices
46. List of Notified Bodies for Medical Devices Directive
47. Guidelines on Medical Devices: EMC Requirements
48. Guidelines on Medical Devices Labelling: USE-BY DATE
49. Guidelines on Medical Devices Labelling: Translation procedures
50. Guidelines on Homogeneous Production Batches
51. 93/65/eec: Directive of Air Traffic Management Equipment & Systems
52. 97/15/eec: amending Directive of Air Traffic Management Equipment & Systems
53. 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
54. Guidelines to directive 94/9/ec (Atex)
55. 2001 Framework of implementation of (Atex)Directive 94/9/ec
56. 94/25/ec: Directive of Recreational Craft
57. 2001 Proposed New Version for: directive 94/25/ec (RecCraft) 55p
58. 2001 Guidelines&Framework: directive 94/25/ec (RecCraft)
59. 95/16/ec: Directive of Lifts
60. 96/48/ec: Directive of Trans-European High-speed Rail System
61. 2001/16/ec: Directive of Interoperability of Trans-European Conventional Rail System
62. 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
63. 96/98/ec: Directive of Marine Equipment
64. 97/23/ec: Directive of Pressure Equipment
65. 2000&2001 Framework: directive 97/23/ec Pressure Equipment
66. 98/37/ec: Directive of Machinery
67. 2000: Comments on Directive of Machinery 98/37/ec
68. Legal Status Of Second-hand and Re-conditioned Machinery
69. Useful Facts relating to Machinery 98/37/ec
70. 2001 Proposal to amend Directive of Machinery 98/37/ec
71. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
72. 2001 Framework of implementation of Directive 99/5/EC R&TTE
73. 2001 Guidance on Directive 99/5/EC R&TTE
74. 2000/9/ec: Directive of Cableway Installations to Carry Persons
75. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
76. 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
77. 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
78. Agreement on Mutual Recognition of conformity assessment between European Union and Canada
79. Agreement on Mutual Recognition of conformity assessment between European Union and Australia
80. Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
81. Agreement on Mutual Recognition of conformity assessment between European Union and Israel
82. Proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan

 

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