This standard will soon be the harmonized standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices). However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system.

The Changes
The scope, terminology and the requirements contained in sections 4 to 8 of EN ISO 13485:2012 are exactly the same as those in ISO 13485:2003. Thefore the ISO 13485 audit criteria being assessed by a certification body or Notified Body have not changed.

The section that has been changed is the Foreword and in particular Annex ZA, Annex ZB and Annex ZC. These annexes link the clauses in ISO 13485:2003 with the requirements of the conformity assessment annexes of Directives 90/395/EEC, 93/42/EEC and 98/79/EC respectively. What these annexes now make clear is that the Directives have requirements which must be met by manufacturers in addition to meeting all the generic requirements in ISO 13485.


As the requirements of ISO 13485 have not changed, certificates issued against ISO 13485:2003 will remain valid and no change in any certificate is strictly necessary. However for some time SGS has been indicating both ISO 13485:2003 the international version and EN ISO 13485:2003 + AC 2009 the European harmonized version on all their UKAS accredited certificates. So when EN ISO 13485:2012 is officially harmonized (expected before the end of 2012) SGS will start to reference ISO 13485:2003 and EN ISO 13485:2012 on all new or amended certificates. The reference to ISO 13485 on CMDCAS certificates will not change as this scheme is based only on ISO 13485:2003. It is expected that other Notified Bodies will take similar action on certificates.


Manufacturers can check the progress of the harmonization of this standard on the EC Commission website.