CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area (EEA) since 1985.
CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.
CE marking is described as a trade passport because it enables the free movement of products within the European market.
According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark. The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.
Seven steps to follow CE Mark on the product:
- Determine the applicable CE directives/regulations
- Identify the applicable European harmonized standards
- Identify which essential requirements of the CE marking directive/regulations apply to the product
- Identify which requirements of the European harmonized standards apply to the product
- Conduct and document the conformity assessment against the essential requirements and the requirements from the standards
- Risk analysis to critical products
- Provide the user with the information required to use the product safely
- Ensure consistency of production, thus proving the assessed sample and the production are identical
- Prepare a document that are necessary to show compliance with all relevant requirements – Technical File.
- Draw up and sign a Declaration of Conformity
- Affix the CE mark to your product