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.