CE Marking

The CE marking as it has been legally called since 1993 (per directive 93/68/EEC)(DECISION No 768/2008/EC), or formerly EC mark, is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer declares that the product conforms with the essential requirements of the applicable EC directives.

The actual meaning of "CE" has been disputed. It is often taken to be an abbreviation of French: Conformité Européenne, meaning "European Conformity". However, "CE" originally stood for "Communauté Européenne", "Comunidad Europea", "Comunidade Europeia" and "Comunità Europea", meaning "European Community". In former German legislation, the CE-marking was called "EG-Zeichen" meaning "European Community mark". According to the European Commission, the CE logo has become a symbol for free marketability of industrial goods within the EEA without any literal meaning, which appears contradictory to what they say today (cf. above reference no. 2).

Legally, the CE marking is not a quality mark. But, depending on the applicable directive, the CE marking can actually be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods, medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC. According to this, medical devices must not only be safe but also function in a medical-technical way as described in the manufacturer's "intended purpose". Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.

Read more about CE MarkingMeaning, Countries Requiring The CE Marking, Rules Underlying CE Marking, Self-certification, Declaration of Conformity, Product Groups, Mutual Recognition of Conformity Assessment, Characteristics of The CE Marking, Dimensions, The E Mark, Misuse

Other articles related to "ce marking, ce":

Pressure Equipment Directive - Contents
... organizations User inspectorates CE marking Unduly affixed CE marking International cooperation Decisions entailing refusal or restriction Repeal Transposition and transitional provisions ... Criteria to be met when authorizing user inspectorates (article 14) Appendix VI CE marking Appendix VII Declaration of conformity ...
Structural Steel - Standards - CE Marking
... The concept of CE Marking for all construction products and steel products is introduced by the Construction Products Directive (CPD) ... Because steel components are “safety critical”, CE Marking is not allowed unless the Factory Production Control (FPC) system under which they are produced has been assessed by a suitable certification ... bolts and fabricated steelwork the CE Marking demonstrates that the product complies with the relevant harmonized standard ...
CE Marking - Misuse - Legal Implications
... There are mechanisms in place to ensure that the CE marking is put on products correctly ... Controlling CE marked products is the responsibility of public authorities in Member States, in cooperation with the European Commission ... authorities if the misuse of the CE marking is suspected or if a product's safety is questioned ...

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