European directive 93/42/EEC, as amended by European directive 2007/47/EC that came into force on 21st March 2010, covers medical devices of all types. Compliance with the directive is mandatory; it sets out the full range of essential requirements that must be met both by the actual medical devices (labelling, clinical trials, quality tests, etc) and by the manufacturer as defined in the regulations (mandatory manufacturer’s declaration, CE marking document drawn up, quality management system maintained, mandatory medical device vigilance, etc). Once the conformity document relating to this directive has been assessed, the regulatory CE marking may be affixed to a device as proof of the company’s quality standards and dependability.