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  • MDR Conformity Assessment Procedure: CLASS Is/Ir/Im

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    Doaa Khalil
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    14 views1 page

    MDR Conformity Assessment Procedure: CLASS Is/Ir/Im

    Uploaded by

    Doaa Khalil

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    MDR Conformity Assessment Procedure CLASS Is/Ir/Im

    Annex I General Safety and Performance Requirements


    Annex II Technical Documentation
    Annex III Technical Documentation on Post Market Surveillance
    Annex IV EU Declaration of Conformity
    Annex VI UDI – Unique Device Identification
    Annex VIII Classification Rules

    Annex IX
    Technical Documentation
    Quality Management System
    (EN ISO 13485)

    Annex XI, Part A


    Production Quality Assurance
    (EN ISO 13485)

    MEDCERT Form Nr. 520103EN / Rev. 1 / 2017.11.07

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