European amendment published for medical devices quality management system standard
Eamonn Hoxey
Retired from technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development
EN ISO 13485 amended to show relationship with European Regulations for medical devices
An amendment to EN ISO 13485:2016 –?Medical devices – Quality management systems – Requirements for regulatory purposes?– was published in September 2021. The amendment replaces the European Foreword and Annexes ZA, ZB and ZC. These Annexes Z from the previous edition of the standard showed the relationship between the clauses of the standard and the requirements of the three European?Directives?for medical devices – those being the Directives for active implantables, medical devices and in vitro diagnostics. These three Annex Zs have been replaced by two new Annex Zs - designated ZA and ZB – which show the relationship between the clauses of the standard and the requirements of the Medical Devices?Regulation?((EU) 2017/745 ) (MDR) and In vitro Diagnostic Medical Devices?Regulation?((EU) 2017/746) (IVDR).