Standard Technical reports · SIS-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

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Standard Technical reports · SIS-CEN/TR 17223:2018

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Scope

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.

Subjects

Management systems (03.100.70) General (11.040.01)

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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

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