BS PD CEN/TR 17223:2018
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

Standard No.

BS PD CEN/TR 17223:2018

Release Date

2018

Published By

SCC

Latest

BS PD CEN/TR 17223:2018

Scope

  Full Description BS PD CEN/TR 17223:2018 provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices. Cross References: ISO 13485:2016 BS EN ISO 13485:2016 All current amendments available at time of purchase are included with the purchase of this document.

BS PD CEN/TR 17223:2018 history

• 2018 BS PD CEN/TR 17223:2018 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