CE Marking

What are the directives that allow for CE Marking?

Not all New Approach Directives allow for CE marking . The Directives that allow CE marking are:

  1. Active implantable medical devices
  2. Appliances burning gaseous fuels
  3. Cableway installations designed to carry persons
  4. Eco-design of energy related products
  5. Electromagnetic compatibility
  6. Equipment and protective systems intended for use in potentially explosive atmospheres
  7. Explosives for civil uses
  8. Hot-water boilers
  9. Household refrigerators and freezers
  10. In vitro diagnostic medical devices
  11. Lifts
  12. Low voltage
  13. Machinery
  14. Measuring instruments
  15. Medical devices
  16. Noise emission in the environment
  17. Non-automatic weighing instruments
  18. Personal protective equipment
  19. Pressure equipment
  20. Pyrotechnics
  21. Radio and telecommunications terminal equipment
  22. Recreational craft
  23. Safety of toys
  24. Simple pressure vessels

What should be the content of technical file?

Generally the technical file requires the following things:

  1. Description of the product
  2. Conceptual Drawing, Component Drawings etc
  3. Result of Risk Analysis
  4. Test Reports against applied Harmonised EN Standards
  5. Labels
  6. Instruction for Use
  7. Signed Declaration of Conformity

Can you claim CE Marking without testing your product?

Annex IV of   LVD Directive and EMC Directive  and Annex VII of the  Machinery Directive clearly asks for test report as a part of the Technical File.