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CEN/TR 17223:2018

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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
Withdrawn date

10-04-2023

Published date

03-21-2018

European Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Relationship between the European Regulations
  for Medical Devices and in vitro Diagnostic
  Medical Devices and the clauses of EN ISO 13485

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.

Committee
CEN/CLC/JTC 3
DocumentType
Technical Report
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

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