By introducing the CE marking into its legislation, the EU has developed an innovative instrument to remove barriers from the circulation of goods and to protect public interest.
Existing in its present form since 1993, the CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the
CE marking on a product, a manufacturer is declaring,on his sole responsibility, conformity with all of the legal requirements to achieve CE marking, and is therefore ensuring validity for that product to be sold throughout the European Economic Area (EEA the 27 Member States of the EU and EFTA countries, Iceland, Norway, Liechtenstein).This also applies to products made in third countries which are sold in the EEA.
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 thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (e.g. safety, health, environmental protection requirements) of the applicable direc tive(s)– or, if stipulated in the directive(s), has had it examined by a notified conformity assessment body.
If you are a manufacturer it is your responsibility to:
- carry out the conformity assessment
- draw up the Technical File
- issue the EC Declaration of Conformity (DoC) or DOP
- affix the CE mark to the product
However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
Products that require to be CE marked are:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- eco-design of energy related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels