The Commission of the European Union (EU) has issued a revised and updated list of standards that can be used to demonstrate conformity with the essential requirements its Directive 93/42/EEC concerning medical devices.
The Directive defines a ‘medical device’ as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application….to be used for human beings for the purpose of: 1) diagnosis, prevention, monitoring, treatment or alleviation of disease; 2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; 3) investigation, replacement or modification of the anatomy or of a physiological process; or 4) control of conception.”
The revised list of CEN and Cenelec standards replaces all previously published standards lists for the Directive, and was published in May 2011 in the Official Journal of the European Union.
Read the revised list of standards for the EU’s Medical Device Directive.
