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  • 1.  EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 21-Nov-2020 14:39
      |   view attached
    Dear Colleagues,

    some time ago I have complied a matrix to identify the matching sections of Annex II of the MDR, and the US documents DMR, DHF and design outputs.
    Should someone wants to use it, feel free.

    regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


  • 2.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 21-Nov-2020 15:52
    Thank you, Peter.  The MDR technical documentation and US device documentation requirements are very extensive and your matrix is a nice reference to summarize the matching areas.  

    Kind regards,

    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    This message was posted by a user wishing to remain anonymous
    Posted 23-Nov-2020 09:15
    This message was posted by a user wishing to remain anonymous

    Trying to consolidate the EU MDR to US device documentation can be a very daunting task.  Your cross reference document is quite helpful, thank you very much.
    Original Message


  • 4.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 24-Nov-2020 03:52
    Dear Peter, very much appreciated.

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------

    Original Message


  • 5.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 25-Nov-2020 02:26
    Dear Peter,

    Thanks a lot for this awesome matrix!

    Kind Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 25-Nov-2020 08:27
    Thanks Peter.

    ------------------------------
    Thierry Houdayer
    Baltimore MD
    United States
    ------------------------------

    Original Message


  • 7.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 25-Nov-2020 17:15
    This is a wonderful summary Peter. Thank you for sharing.

    ------------------------------
    Michelle Knight
    Clinical and Regulatory Manager
    Coburg VIC
    Australia
    ------------------------------

    Original Message


  • 8.  RE: EU MDR Annex II, design output, DMR, DHF matrix - document to share

    Posted 30-Nov-2020 02:21
    Hi Peter-
    Thank you for sharing this matrix. It is extremely helpful.

    Best,
    Ritam

    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
    ---------------------------------



    Original Message


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