CE Marking

To enable the free movement of goods and services within the EU, there are a number of EU directives which set basic requirements in respect of safety, health and environmental protection. These directives must be transposed by Member States into their national legislation.

The directives do not contain any technical details, which are set in harmonised standardsStandards usually refer to the rules of engineering. There are also, however, standards relating to other areas. One such area is accountancy, which is subject to the International Accounting Standards (IAS). Standards promote rationalisation, make quality assurance possible, encourage safety both inside and outside the workplace, harmonise testing methods in such areas as environmental protection, and generally help create a consensus regarding the economy, technology, science, administration and the general public.

Standards also promote the free movement of goods and services. Within the European Union (EU) and the European Economic Area (EEA), the application of harmonised standards makes it easier to prove conformity with basic health and safety requirements (CE marking) for a large number of industrial products. Standards are not created at state level, but by the very people who need them within the fields of finance, consumer rights, administration and science. Representatives from these fields invest their time and expertise in creating standards to suit both their own interests and the broader interest.

There are Swiss standards (SN), European standards (EN), international standards (ISO and IEC), as well as what are known as works standards. Switzerland’s body of standards (well in excess of 10,000 documents from every industry and sector of the economy and society) is maintained by the Swiss Association for Standardization (SNV).
developed by the European standardisation bodies CEN, CENELEC and ETSI. Products manufactured according to one or several harmonised standards (which are published in the EU Official Journal) are considered as meeting the basic safety and health requirements set by the standard(s) in question.

The harmonised standards may be ordered from the Swiss Association for Standardization (SNV): www.snv.ch.

In order to be placed on the market, a product must comply with certain essential requirements. Manufacturers must ensure that their products comply with applicable requirements by carrying out or commissioning a product conformity assessment procedure. If the product complies with the essential requirements, the manufacturer affixes the CE markingThe 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
Construction products
Electromagnetic compatibility
Equipment and protective systems in potentially explosive atmospheres
Explosives for civilian use
Low voltage equipment
Machinery safety
Measuring instruments
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
Pressure equipment
Radio and telecommunications terminal equipment
Recreational craft
Simple pressure vessels
Toy safety
on the product and draws up an EC declaration of conformity. Manufacturers indicate their name, registered trade name or registered trade mark, as well as their address on the product. They must ensure that series production remains in conformity. The product must be accompanied by instructions and safety information in a language which can be easily understood. In the case where an external conformity assessment body intervenes, the manufacturer must affix the body's identification number.

The importer and the distributor must ensure that the manufacturer has fulfilled his obligations, i.e. check that the product has a conformity marking and that the required documents have been supplied.

Manufacturers (or their authorised representative), distributors and importers must provide the competent authorities with all necessary information on the product concerned in order to ensure product traceability.

In Switzerland, the Federal Act on Product Safety (PrSG) aims on the one hand at guaranteeing the safety of products on the market for commercial or professional uses and, on the other hand, at reducing technical barriers to trade by harmonising Swiss legislation with the rules of the European Union – Switzerland’s largest trading partner. The PrSG Act transposes Directive 2001/95/EC on general product safety into Swiss law.

Is CE marking compulsory in Switzerland?

CE marking is not mandatory in Switzerland but products bearing the CE mark are allowed on the Swiss market. CE marking is only required for goods exported from Switzerland to the EU (or EEA) which fall within the scope of EU directives.

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