What is CE Marking certificate?
CE certificate shows that the product complies with European Union legislation and allows the free consumption of products within the European market.
The letters ‘CE’ appear on many products that are traded on the single market in theEuropean Economic Area (EEA).
The CE marking is required for many products:
– Shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
– Is an indicator of a product’s compliance with EU legislation
– Allows the free movement of products within the European market
By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout theEEA. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
If you are a manufacturer it is your responsibility to:
– Carry out the conformity assessment
– Set up the technical file
– Issue the EC Declaration of Conformity (DoC)
– Place CE marking on a product
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.
If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.
Products that need CE marking
CE marking is mandatory, but only for those products which are covered by the scope of one or more of the New Approach Directives.
Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all products sold in the EU need to bear CE marking.
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
|1. Active implantable medical devices||13. Measuring instruments|
|2. Appliances burning gaseous fuels||14. Medical devices|
|3. Cableway installations designed to carry persons||15. Noise emission in the environment|
|4. Eco-design of energy related products||16. Equipment and protective systems intended for use in potentially explosive atmospheres|
|5. Electromagnetic compatibility||17. Non-automatic weighing instruments|
|6. Explosives for civil uses||18. Personal protective equipment|
|7. Hot-water boilers||19. Pressure equipment|
|8. Household refrigerators and freezers||20. Pyrotechnics|
|9. In vitro diagnostic medical devices||21. Radio and telecommunications terminal equipment|
|10. Lifts||22. Recreational craft|
|11. Low voltage||23. Safety of toys|
|12. Machinery||24. Simple pressure vessels|
♦ The CE marking is not required for items, for example:
- Cosmetics and foodstuffs
♦ Process of CE Marking certification