The European Union publishes guidance documents for medical devices. These guidance documents provide valuable information for companies that supply medical devices subject to the Medical Device Directive (MDD), 93/42/EEC as amended by Directive 2007/47/EC.
The EU publishes the guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines
In June 2010, the EU published revision 9 of MEDEV 2.4/1 Classification of Medical Devices.
This document is a revision of an earlier document published in July 2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to the changes in classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001, including derogation of the classification rules in the case of breast implants and hip, knee and shoulder joint replacements and requirements related to devices containing human blood derivatives and medical devices manufactured utilizing tissues of animal origin. In addition this guidance document takes account of the changes arising from Directive 2007/47/EC which further amends Directive 93/42/EEC and became applicable as from 21st March 2010.