CE standard

the mark CE what does it mean?

The CE mark is derived from the French phrase "Conformité Européene" which means "conforming to Europe". The initial term was EC, which was officially replaced by the CE mark in 1993, instead of EEC. The CE mark is currently used in all official documents of the European Union. 1. The CE mark is a product manufactured in accordance with the basic requirements of European health, safety and environmental protection laws, which are the directives for product terms. The directives contain "basic requirements" or "performance levels" and "harmonized standards". which must conform to the product. And harmonized standards are technical specifications (European standards or harmonization documents) created by several European standardization organizations (CEN, CENELEC, etc.). CEN stands for European Committee for Standardization. CENELEC stands for Electrotechnical standardization is the European Committee.

2. Marking on a product indicates to government authorities that the product may be legally placed on the market in their country.
3. The CE mark guarantees the free supply of the product in the common market of EFTA and European Union (EU) (including 30 EEA countries) and
4. It allows the export of unauthorized products by EEA customs and enforcement/vigilance authorities.

European Economic Area (EEA):

The EEA includes the countries of the European Union as well as Iceland, Liechtenstein and Norway. This allows them to be part of the EEA common market.

Although Switzerland is a member of EFTA, it is not a member of the European Union or EEA. However, it is still part of the market.

As more directives come into effect, more products need to receive the CE mark to access the EFTA and EU markets. However, many non-EU exporters are still unaware of this fact and its impact on their business.

General principles of the sign CE

1. The CE mark should only be affixed by the manufacturer or its authorized representative.
2. The CE mark is prepared for the products of organizations with special rules.
3. With CE approval, the manufacturer shows that he can advance the product in line with the laws of the society.
4. The CE mark must comply with EU regulations.
5. Any design or CE symbol that misleads third parties is prohibited.
6. Member States must ensure the implementation of CE laws in order to take the necessary measures in case of misuse. Also, Member States violate laws that may be part of legal criminal sanctions, in which case heavy penalties should be considered.

For more information, you can refer to the following sources:

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