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  • CEN/TR 17223:2018

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Available format(s): 

    Withdrawn date:  04-10-2023

    Language(s): 

    Published date:  21-03-2018

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/CLC/JTC 3
    Document Type Technical Report
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

    Standards Referencing This Book - (Show below) - (Hide below)

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