CE marking is a mandatory European marking for certain product categories. It indicates compliance with the essential health and safety requirements set out by the relevant EU Directives.
The CE marking may be affixed to a product if it falls within the scope of at least one of the 22 EU New Approach directives. A product without the CE marking and therefore without complying with the requirements as specified in the directives that apply to it, should not be on the EU market. On the other hand, if the product fulfills the requirements of the directives that apply to it, then no EU country can prohibit, restrict or impede its circulation in its territory. For this reason, the CE marking is also considered as the trade passport of the products. The CE marking is not a quality label but refers more to safety than to product quality. Most product quality labels are voluntary for manufacturers, unlike the CE mark, which is mandatory for the products to which they apply. CE indicates compliance with European safety requirements, and is established by following clear and distinct procedures called “compliance verification procedures”. For most types of products, affixing the CE mark presupposes the existence of the Technical File, the key element of which is the Test Reports.