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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 CEN/TR 17223:2018

Publication date:   May 17, 2018

General information

99.60 Withdrawal effective   Sep 13, 2023

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Technical Report

03.100.70   Management systems | 11.040.01   Medical equipment in general

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Scope

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

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CEN/TR 17223:2018
99.60 Withdrawal effective
Sep 13, 2023