New Revision to Harmonized Standards Related to the Medical Device Directive

The list of standards harmonized to the Medical Device Directive (MDD) now includes the list of July 7, 2010 in the Official Journal.

Two standards of particular interest to general medical device practitioners are ISO 13485 and ISO 14971.

For ISO 13485, the current version is EN ISO 13485:2003/AC:2009.

This version is based on EN ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) that superseded EN ISO 13488:2000, EN ISO 13485:2000, and EN 46003:1999 on July 31, 2009.

For ISO 14971, the current version is EN ISO 14971:2009 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) that superseded EN ISO 14971:2007 on March 21, 2010.

One can view the complete list at