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  • Certificate

    CE Certificate

  • Definition: CE marking (originally 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 ensures that the product conforms with the essential requirements of the applicable EC directives. The letters "CE" stand for "Conformité Européenne" ("European Conformity").

    Legally, the CE marking is no quality mark. But depending on the applicable directive the CE marking factually can 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 which medical devices have to be not only 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.