The CE marking serves as proof that a product meets the basic health and safety requirements under EU law, and that the necessary conformity assessment procedures have been performed. CE marking is mandatory for all goods covered by the 20 or so EU directives under what is known as the New Approach in cases where these goods are to be put into circulation within the single European market or the European Economic Area (EEA). In many cases, CE marking can be carried out by the manufacturers themselves. The mark denotes neither quality nor origin; it is an administrative tool intended to promote the free movement of goods. This makes it a “technical passport”, valid within the single European market and the EEA.
As a result of the federal law relating to technical barriers to trade, Switzerland has already largely harmonised its product regulations with the corresponding EU legislation. There is still, however, no requirement for CE marking to be applied to goods in Switzerland. A Mutual Recognition Agreement (MRA) ensures that testing procedures, test certificates and conformity signs associated with CE marking are recognised by both parties. This avoids the need for double testing, saving both time and money. The MRA is part of the Bilateral Agreements I between Switzerland and the European Union which came into effect on 1st June 2002.
The individual European Directives stipulate whether and to what extent a product must show the CE marking. Producers are responsible to ensure that their products conform fully with all relevant directives. Presently, there are about 20 directives (New Approach Standardisation) on CE marking. They include:
Cableway installations designed to carry persons
Equipment and protective systems in potentially explosive atmospheres
Explosives for civilian use
Low voltage equipment
Medical devices: Active implantable
Medical devices: General
Medical devices: In vitro diagnostic
New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements)
Non-automatic weighing instruments
Packaging and packaging waste
Radio and telecommunications terminal equipment
Simple pressure vessels