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  • 1.  Clinical evaluation evidence under MDR

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2021 10:20
    This message was posted by a user wishing to remain anonymous

    Hi Team,

    We have a class IIb device which is 510(k) cleared and is currently undergoing review by NB under MDR. To show the equivalency we don't have enough literature available. Can we show the field collected data in CER to demonstrate the safety and performance of the device. The device doesn't have any residual risk, so we don't have plans to show the PMCF studies.


    Can anyone suggest on this strategy?


    Thanks


  • 2.  RE: Clinical evaluation evidence under MDR

    Posted 10-Aug-2021 09:15
    Dear Colleague,

    you may integrate the contents of the guidance of MEDDEV 2.7.1.rev.4. (see A.1), the applicable sections of the MDR and the guidance MDCG 2020-5.

    regards

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

    Original Message


  • 3.  RE: Clinical evaluation evidence under MDR

    Posted 10-Aug-2021 11:33
    Edited by Richard Vincins 10-Aug-2021 11:34
    Hello Anon,

    There really is no linkage between claiming an equivalent device and clinical literature according to the EU MDR and MEDDEV 2.7/1.  Now, it does not mean you can not do literature searches for the equivalent device or even similar devices to see if there is any published information concerning the device.  The main focus of an equivalent device is supporting the technical, biological, and clinical characteristics are "equivalent" between the two devices.  This is proven through supportive scientific information/evidence the two devices are equivalent.  This could be a number of items from clinical literature of comparative studies, non-clinical bench comparative studies, technical information such as from IFUs or specifications, or other sources.  It is a step-by-step process to show clinical evidence supporting the safety and performance of your device and equivalency discussion is just one step in the process.

    Edit:  You should also delete the other two threads (assuming) because they are the same question to keep information in one thread.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Clinical evaluation evidence under MDR

    Posted 11-Aug-2021 03:41

    Dear Anon

     

    In response to previous comments in this forum: the demonstration of equivalence has a different definition under the MEDDEV 2.7/1 Rev. 4 and the MDR. For a medical device certification under the MDR, you must use the MDR definition of equivalence.

    The MDR guidance to equivalence is MDCG 2020-5.

    https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf

     

    Best Regards,

    Stephanie

     

    MedTechXperts GmbH
    Jungenbergstrasse 7
    CH-5023 Biberstein
    Switzerland

    sgrassmann@medtechxperts.com

    info@medtechxperts.com
    http://www.medtechxperts.com

     

    Expediting Market Access & Ensuring the Success of Your Medical Device



    ------------------------------
    Stephanie Grassmann
    Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


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