CE Marking (“Conformité Européenne” meaning European Conformity) is a certification mark mandatory for all products placed on the market in the European Economic Area. This certification signifies that the product conforms with high safety, health and environmental protection requirements. However, not all products require CE marking. Only the products for which EU specifications have been introduced require CE marking. EU requirements are laid down for more than 20 product sectors in “New Approach” Directives (also called regulations) including but not limited to:
If a product falls under the scope of any of the product sectors, then it must go through conformity assessment. It is possible that a product falls under the scope of more than one directive or regulation in which case, it must conform to all that applies.
The “New Approach” Directives lay down essential requirements that a product must meet before being placed on the EU market, however, the technical details outlining the minimum requirements are usually not found in the Directive itself. This is different from the “Old Approach” Directives which contained a high degree of technical details. In other words, the “New Approach Directives” are rather general.
Today, to provide a technical solution in meeting the essential requirements, some European standards are adopted for specified products targeting certain essential requirements within the directives. This means that if harmonised European standards for a product exist, and the manufacturer follows them in the production process, the product will be presumed to be in conformity with requirements targeted by those standards in the relevant EU directive. Yet using standards are voluntary. This gives manufacturers the flexibility to opt for other technical solutions available in general engineering and scientific literature to assess conformity. The references of harmonized standards available for each directive can be found in the Official Journal of the European Union (OJEU).
It is the manufacturer’s responsibility to:
When Importers or distributors market a product under their own name, they take over the responsibilities of the manufacturer. However, for certain products where safety risks are higher, it is necessary for an independent third party to carry out conformity assessment. Bodies notified by EU countries will perform product-type tests and issue a declaration of conformity (DoC). For a list of notified bodies please refer to the NANDO website.
Click one of the links below for more information: