CE

The letters CE stand for "Conformité Européenne", a French term meaning "European Conformity". By affixing the CE marking, the person responsible declares that they have ensured compliance with all applicable EU regulations and have carried out a corresponding conformity assessment procedure.

What does "CE" mean?

The letters CE stand for "Conformité Européenne", a French term meaning "European Conformity". By affixing the CE marking, the person responsible declares that they have ensured compliance with all applicable EU regulations and have carried out a corresponding conformity assessment procedure.

The CE marking is a symbol that your product complies with the European Union regulations governing the safety and quality of products sold in Europe. It is not a quality mark, but a declaration by you, the manufacturer, distributor or EU authorized representative, that your product complies with all applicable requirements set out in Community harmonization legislation for its affixing.

The CE marking is used to indicate conformity with all relevant requirements set out in Community harmonization legislation providing for its affixing.

If your product has been assessed and approved by a Notified Body (a third party organization that tests your products), your CE marking will include an identification number for that Notified Body.

The CE mark is a certification mark indicating that a product complies with the essential requirements of the relevant European legislation in the areas of health, safety and environmental protection. It does not certify quality or reliability.

The CE marking can be affixed to products sold within the European Economic Area (EEA) in order to market them throughout the EEA. The EEA consists of all EU countries plus Norway, Iceland and Liechtenstein.

The original spelling of the acronym CE is not clear and is not defined in the official regulations. According to the responsible standardization institute CENELEC, today it stands for Conformité Européenne 'European Conformity' in French. However, at the time of its introduction, CE was also the usual abbreviation for the European Community in four of the nine official languages at the time, and in official German documents the mark was usually still called "EG-Zeichen", which is why it can also be traced back to this. Until 1993, the CE mark was still called the "CE mark", since then the official designation has been "CE marking".

The term was introduced for all harmonization directives already adopted by Council Directive 93/68/EEC of 22 July 1993 amending the Directives

  • Directive 87/404/EEC (simple pressure vessels),
  • Directive 88/378/EEC (safety of toys),
  • Directive 89/106/EEC (construction products),
  • Directive 89/336/EEC (electromagnetic compatibility),
  • Directive 2006/42/EC (machinery),
  • Directive 89/686/EEC (personal protective equipment),
  • Directive 90/384/EEC (non-automatic weighing instruments),
  • Directive 90/385/EEC (active implantable medical devices),
  • Directive 90/396/EEC (gas appliances),
  • Directive 91/263/EEC (telecommunications terminal equipment),
  • Directive 92/42/EEC (new hot water boilers fired with liquid or gaseous fuels) and
    Directive 73/23/EEC (electrical equipment designed for use within certain voltage limits).

The CE marking is a symbol that indicates that a medical device has been approved by the European Union. The CE marking was first introduced in the 1980s and is now a well-known symbol in the medical device industry.

The correct term for this symbol is "CE marking" (see Art. 17 and Annex XII of Directive 93/42/EEC). According to the official language of the European Commission, Directorate-General for Enterprise and Industry (Regulatory Policy), the stylized letter combination has been a graphic symbol since 1994.

According to the European Commission, this symbol no longer has a literal meaning, but is a symbol of free marketability in the EU.

The CE marking is a mandatory conformity marking that indicates that the product has been manufactured in accordance with all applicable European Union (EU) directives. With the CE marking, the manufacturer or distributor confirms that the product complies with the product-specific applicable European directives (since December 1, 2009, with the entry into force of the Treaty of Lisbon: EU directives)[5] The CE marking alone does not allow any conclusions to be drawn as to whether the product has been checked by independent bodies for compliance with the directives. However, if the CE marking is followed by a four-digit identification number (ID number), this indicates that a notified body has been involved. In legal terms, the CE marking is not a seal of approval (quality mark), but documents compliance with the minimum legal requirements.

The CE marking was created primarily to ensure safe products for the end user within the European Economic Area, which comprises 30 contracting states, including the European Community (EC), now the European Union (EU). The CE marking is often referred to as a "passport" in order to

EU directives pursuant to Art. 288 (3) TFEU (so-called internal market or harmonization directives) lay down safety and health requirements for numerous products. If a product complies with the essential requirements of all applicable EU directives and a conformity assessment procedure has been carried out in accordance with the procedures set out in Annex II of Decision No. 768/2008/EC of the European Parliament and of the Council of July 9, 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218/82), it may be placed on the market and put into service in the EU for the first time.

As part of the New Approach to Product Conformity and the Overall Approach to Conformity Assessment, regulations have been created that are intended to serve technical harmonization in the EU internal market.

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