The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area(EEA) since 1985.[1] The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
It consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.
The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.
Officially, "CE" is an abbreviation of Conformité Européenne, meaning European Conformity. However, "CE" originally stood for "Communauté Européenne", French for "European Community". In former German legislation, the CE marking was called "EG-Zeichen" meaning "European Community mark". The CE marking is a symbol of free marketability in the European Economic Area (Internal Market).
Existing in its present form since 1995, the CE marking indicates the compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market. By affixing the CE marking on a product, a manufacturer is declaring, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area. CE marking is intended for national market surveillanceenforcement authorities.
CE marking signifies that the product conforms with all EU directives or EU regulations that apply to it. For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive; toys must comply with the Toy Safety Directive. The marking does not indicate EEA manufacture.[5] The manufacturer of CE-marked goods has verified that the product complies with all applicable EU requirements, such as safety, health, and environmental protection, and, if stipulated in any EU product legislation, has had them examined by a Notified Body or produces according to a certified production quality system. The CE marking also indicates that the product complies with directives in relation to 'Electro Magnetic Compatibility - meaning the device will work as intended, without interfering with the use or function of any other device.
Not all products need CE marking to be traded in the EEA; only product categories subject to relevant directives or regulations are required (and allowed) to bear CE marking. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer (Module A; see Self-certification, below), with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers.[7]
CE marking is a self-certification scheme. Retailers sometimes refer to products as "CE approved", but the mark does not actually signify approval. Certain categories of products require type-testing by an independent body to ensure conformity with relevant technical standards, but CE marking in itself does not certify that this has been done.
CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards.
As of 2013 CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but members Republic of Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation (as did most Central European former member countries of CEFTA that joined the EU, before joining).
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.
The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out aconformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request.
Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.
Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a Notified Body, is of great importance throughout the entire CE-marking process, from Design Verification, and set up of Technical File to the EC Declaration of Conformity.