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DS 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

Jun 20, 2019

General information

60.60     Jan 30, 2019

DPS

DPS/KT 316

Technical Report

03.100.70     11.040.01  

English  

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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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PUBLISHED
DS CEN/TR 17223:2018
60.60 Standard published
Jan 30, 2019

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Adopted from CEN/TR 17223:2018

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