The presence of the CE marking on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.
The CE mark's creators may have derived it as an acronym of the French words "Conformité Européenne".However, the European Commission (the executive branch of the European Union) does not appear to acknowledge this definition.No reliable source confirms that CE is an abbreviation for anything.
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.