The European Commission has recognized EN ISO 13485:2003 as a harmonized standard for medical device manufacturing quality management systems for regulatory purposes under the three medical device directives, the Medical Device Directive, Active Implantable Medical Device Directive and In Vitro Diagnostics Directive.

Harmonization means that the ISO 13485:2003 standard is now formally recognized for use to demonstrate that the quality assurance requirements for CE marking of medical devices have been met. It carries a presumption of conformity with the relevant requirements of the medical device directives.

The European Commission also announced that EN ISO 13485:2000, identical to ISO 13485:1996, and EN ISO 13488:2000, identical to ISO 13488:1996, will cease to provide a presumption of conformity with relevant requirements of the medical device directives on July 31, 2006.

Source: BSI Medical Devices E-mail Update

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