The CE Mark Enables Export of Products to the EU and Other Countries.

The CE mark is a symbol of product conformity with the requirements of the European Union directives. These directives impose essential requirements, with detailed specifications provided in harmonized standards. Once a product gains the right to bear the CE mark, it can be freely placed on the market of the European Economic Area (EEA), which includes the 28 EU member states and 4 EFTA member states. While the CE mark is not yet mandatory for placing products on the market in CEFTA member states, many of them are official candidates for EU membership and are widely adopting harmonized standards (Bosnia and Herzegovina, Serbia, Montenegro, and North Macedonia).

The CE mark has implications for manufacturers, importers, and distributors, as described in detail below:
Manufacturers must conduct a conformity assessment, establish a technical file, and sign an EC declaration of conformity before affixing the CE mark to their product.
Products can only be placed on the market if they comply with the provisions of all applicable directives and have undergone the conformity assessment procedure accordingly.
Importers must confirm that the manufacturer outside the EU has taken the necessary steps to affix the CE mark to the product. Importers must also ensure that the CE marking documentation is available upon request.

Distributors must be able to provide sufficient documentation confirming that both the manufacturer and the importer have completed all necessary steps for affixing the CE mark to the product.
Upon completing tests with the CE mark, the Institute for Standards and Safety compiles a detailed testing report that includes all test results and any corrective actions that may require attention.

The technical documentation required to obtain the CE mark mainly consists of the following documents:

• Essential requirements
• Product description
• Numerical calculations
• Graphic documentation: drawings, schematics, etc.
• Component specifications
• List of applied harmonized standards
• Test reports
• Photo documentation
• Risk analysis
• User manual
• Label EC manufacturer's declaration of product conformity

Contact us for more information on how the Institute for Standards and Safety can assist you in identifying and meeting your CE marking needs.