CE Marking & Conformity
CE marking is an indicator that a product complies with EU legislation and enables the free movement of products within the European market. When a manufacturer affixes the CE marking on a product, he declares, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area, Switzerland and Turkey.
This also applies to products made in third countries which are sold in the EEA, Switzerland and Turkey. CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and meets the EU safety, health and environmental protection requirements. It means that the manufacturer has verified that the product complies with all relevant essential requirements of the applicable directive(s) or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.
It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EC declaration of conformity and to affix the CE marking on the product. Distributors must verify the presence of both the CE marking and the necessary supporting documentation. If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.
Not all products must bear the CE marking. Only those product categories subject to specific directives (New Approach Directives) that provide for CE marking are required to be CE marked. There are more than 20 directives setting out the product categories requiring CE marking. The products range from electrical equipment to toys and from civil explosives to medical devices. The essential requirements that products have to fulfil are harmonized at EU level and are set out in general terms in these directives.
Harmonised European standards are issued with reference to the applied directives and express in detailed technical terms the essential requirements. The two main sources to find harmonised standards are the European Commission website and the New Approach website. Full compliance of a product with the harmonised standards gives a product the “presumption of conformity” with the relevant essential requirements. While the CE marking is mandatory, the use of harmonised standards remains voluntary. Other ways to fulfil these essential requirements can be chosen.
>> For more information, refer to the SBS brochure on conformity assessment.