PD CEN/TR 17223:2018
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English
21-03-2018
This Technical Report 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.
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