The full title is Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. The earlier blog on this topic noted that:
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016). CEN publish Technical Report to assist in transition of quality management systemsĮN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes – was harmonised for the Medical Device Directive, Active Implantable Medical Device Directive and In Vitro Diagnostic Medical Devices Directive in November 2018. Understanding the New ISO 13485:2016 Revision.
