CEN/TR 17223:2018
Withdrawn Standard
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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

Summary

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.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 03/23/2018
Cancellation Date 09/13/2023
Page Count 19
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ISBN ---
Weight (in grams) ---
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