CE Mark

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). 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.

The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives. "CE" originated in 1985 as an abbreviation of Conformité Européenne, meaning European Conformity, but is not defined as such in the relevant legislation. The CE marking is a symbol of free marketability in the European Economic Area (Internal Market).

Meaning

Existing in its present form since 1985, the CE marking indicates that the manufacturer or importer claims compliance with the relevant EU legislation applicable to a product, regardless of the place of manufacture. By affixing the CE marking on a product, a manufacturer effectively declares, 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.

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 or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety, health, and environmental protection. 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.

CE marking involves self-certification. 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.

Countries requiring the CE marking

CE marking is mandatory for certain product groups within the European Economic Area 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).

Rules underlying CE marking

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 a conformity 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.

Self-certification

Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. In order to self-certify, the Manufacturer must do several things.

1. Decide whether the product needs to have a CE marking. The product must conform to all Directives that apply to the product.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below.

Module A - Internal production control.
Module B - EC type-examination.
Module C - Conformity to type.
Module D - Production quality assurance.
Module E - Product quality assurance.
Module F - Product verification.
Module G - Unit verification.
Module H - Full quality assurance.

These will often ask questions about the product to classify the level of risk and then refer to the "Conformity Assessment Procedures" chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE marking.

EU declaration of conformity

The EU declaration of conformity must include –

  • manufacturer's details (name and address, etc.)
  • essential characteristics the product complies
  • European standards and performance data

Product groups

The directives requiring CE marking affect the following product groups/p>

  • Active implantable medical devices S
  • Surgical instruments
  • Appliances burning gaseous fuels
  • Cableway installations designed to carry persons
  • Construction products (according to Regulation under specific rules)
  • 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
  • In vitro diagnostic medical devices
  • Lifts
  • Products used under Low voltage
  • Machinery
  • Measuring Instruments
  • Medical devices
  • Noise emission in the environment
  • Non-automatic weighing instruments
  • Personal protective equipment
  • Pressure equipment
  • Pyrotechnics
  • Radio and telecommunications terminal equipment
  • Recreational craft
  • Restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS
  • Safety of toys
  • Simple pressure vessels