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  • 1.  MDR Consolidated

    This message was posted by a user wishing to remain anonymous
    Posted 27-Apr-2020 17:04
    This message was posted by a user wishing to remain anonymous

    Does anybody have the URL for the PDF version of the MDR after the recent amendment?



  • 2.  RE: MDR Consolidated

    Posted 27-Apr-2020 17:40
    I'm assuming you're asking about EU MDR? If so, I go here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505  . You can choose either the PDF or the HTML version of your language (e.g. EN for English version).

    Have fun!

    ------------------------------
    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------

    Original Message


  • 3.  RE: MDR Consolidated

    Posted 28-Apr-2020 03:36
    As far as I could see, a consolidated version of the MDR 2017/745, including the Regulation 2020/561 'amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions' is not available (yet).

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: MDR Consolidated

    This message was posted by a user wishing to remain anonymous
    Posted 28-Apr-2020 08:43
    This message was posted by a user wishing to remain anonymous

    I followed the link, but it does not include the recent change to the date of application.

    Can you tell me where that is? It is the one I want.

    Original Message


  • 5.  RE: MDR Consolidated

    Posted 28-Apr-2020 09:01
    https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: MDR Consolidated

    Posted 28-Apr-2020 04:56
    This link is also extremely helpful. The cross-links in the regulation make life a lot easier navigating the MDR.
    https://www.johner-institut.de/blog/wp-content/uploads/2020/02/MDR_Consolidated_EN.html#chapter-I
    You would have to check when last it was updated.

    Best

    ------------------------------
    Malcolm Applewhite
    QA/RA Manager
    Cape Town
    South Africa
    ------------------------------

    Original Message


  • 7.  RE: MDR Consolidated

    Posted 18-May-2020 08:12
    The consolidated version that includes the two correction documents and the new legislation is available from

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424


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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 8.  RE: MDR Consolidated

    Posted 18-May-2020 10:30
    Thank you Dan, much appreciated!

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


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