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  • MDR Conformity Assessment Procedure Overview

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    Doaa Khalil
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    This document provides an overview of the MDR conformity assessment procedure. It outlines the key annexes and requirements around general safety, technical documentation, post-market surveillance, declarations of conformity, unique device identification, and classification rules. It also shows the classification rules and conformity assessment routes for different types of medical devices, including production and product quality assurance procedures.

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    MDR-Conformity-Assessment-Procedure-Overview

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    This document provides an overview of the MDR conformity assessment procedure. It outlines the key annexes and requirements around general safety, technical documentation, post-market surveillance, declarations of conformity, unique device identification, and classification rules. It also shows the classification rules and conformity assessment routes for different types of medical devices, including production and product quality assurance procedures.

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    © All Rights Reserved
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    64 views1 page

    MDR Conformity Assessment Procedure Overview

    Uploaded by

    Doaa Khalil
    This document provides an overview of the MDR conformity assessment procedure. It outlines the key annexes and requirements around general safety, technical documentation, post-market surveillance, declarations of conformity, unique device identification, and classification rules. It also shows the classification rules and conformity assessment routes for different types of medical devices, including production and product quality assurance procedures.

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    MDR Conformity Assessment Procedure OVERVIEW

    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

    I Is IIb Is IIa Ir
    Ir III IIb Im III
    Im
    IIa
    Annex X Annex IX
    Type Examination Technical Documentation
    Quality Management System
    (EN ISO 13485)

    Is IIb active devices


    Is IIa Ir to administrate and/or
    Ir IIb Im remove a medicinal product
    Im III IIa III implantable
    IIa IIb III medicinal
    IIb III III human origin
    III III animal origin
    III absorbed/dispersed

    Annex XI, Part A Annex XI, Part B Annex IX, Section 5


    Production Quality Assurance Product Verification Specific Additional Procedures
    (EN ISO 13485)

    MEDCERT Form Nr. 520101EN / Rev. 1 / 2017.11.07

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