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

Published by	Publication Date	Number of Pages
BSI	03/21/2018	88

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Category: BS

Description

BS PD CEN/TR 17223 – 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

BS PD CEN/TR 17223:2018 provides guidance on the relationship between EN ISO 13485:2016, Medicaldevices – Quality management systems – Requirements for regulatory purposes and the requirementsin EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro DiagnosticMedical Devices.

Cross References:
ISO 13485:2016
BS EN ISO 13485:2016

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