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ISO 13485:2003 and Medical Devices Harmonize

Published: Sunday, April 25, 2004 - 22:00

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

To subscribe to BSI’s medical devices e-mail update, click here.

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For 38 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest Daily, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.