EU Publishes EN ISO 13485:2012

E-update - 22 February 2012

The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012. This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. The revised standard will be available in the upcoming weeks.

EN ISO 13485 provides a framework to enable a manufacturer to meet some of the quality system requirements for an EC Declaration of Conformity (Annex 2 and Annex 5 of Directive 90/385/EEC AIMD; Annex II, V and VI of Directive 93/42/EEC MDD; or Annex III, IV and VII of Directive 98/79/EC IVDD). As the EU harmonized standard for medical device quality management systems, it is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation, based on a sound regulatory interpretation for implementation in their quality management systems.

Presumption of Conformity

During 2011, The European Commission raised an objection to the harmonization status, and the implied Presumption of Conformity of a number of European Standards including EN ISO 13485. Additionally, Sweden raised a formal objection to the European Commission in February 2011 on the link between adhering to the standard and compliance to the Directives.

To restore confidence and bring back the presumption of compliance indicated by the harmonized status of the standard, it was essential to revise the Annexes ZA, ZB and ZC and add further details on the link between standards, and the three Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. All signs are clear for the new EN ISO 13485:2012 to be harmonized, and will most likely happen by summer 2012.


Once EN ISO 13485:2012 is harmonized, there will be no need for existing BSI customers with ISO 13485 certificates (UKAS accreditation) to undergo an automatic update or re-issue of certification. This is because there is no changed in the normative text (requirements) of the standard.

After the date of harmonization, any new BSI ISO 13485 certificates (UKAS accreditation) issued will specify ISO 13485:2012, and any existing certificates being renewed or reissued to support changes after this date will be updated at the point of reissue to also refer to ISO 13485:2012. All BSI ISO 13485 certificates issued under SCC accreditation (including CMDCAS) will continue to reference ISO 13485:2003 as it is only the European version of the standard that is changing.