SN-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.

SN-CEN/TR 17223:2018

Release Date

2018

Published By

SCC

Latest

SN-CEN/TR 17223:2018

Scope

  Full Description ADOPTED_FROM:CEN/TR 17223:2018 This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

SN-CEN/TR 17223:2018 history

• 2018 SN-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