SIS-CEN-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

SIS-CEN-17223 - 2018 EDITION - CURRENT


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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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Designation Name

SIS-CEN/TR 17223:2018

Revision Level

2018 EDITION

Status

Current

Publication Date

March 28, 2018

Language(s)

English

Page Count

96