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.
- PD CEN/TR 17223:2018
- Release Date
- 2018
- Published By
- CEN - European Committee for Standardization
- Latest
- PD CEN/TR 17223:2018
- Scope
- This Technical Report provides guidance on the relationship between EN ISO 13485:2016@ Medical devices ?C Quality management systems ?C 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.
PD CEN/TR 17223:2018 history
- 2018 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
