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  • 1.  MDCG 2024-1

    This message was posted by a user wishing to remain anonymous
    Posted 14 days ago
    This message was posted by a user wishing to remain anonymous

     I have a question in regard to recently released MDCG 2024-1, Guidance on the vigilance system for CE-marked devices DSVG 00 Device Specific Vigilance Guidance
    (DSVG) Template.  Does anyone have any idea what this document is referring to?  What is a Specific Device, that the guidance repeatedly refers to?



  • 2.  RE: MDCG 2024-1

    Posted 14 days ago

    The term specific device is very broad, and the meaning is that different devices have different reporting requirements.  As an example: Implants vs class I no sterile.  You need apply the guidance in accordance with your specific device. 



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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
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  • 3.  RE: MDCG 2024-1

    Posted 14 days ago

    MDCG 2024-1 is simply a template to be used by the MDCG when it writes and issues device specific vigilance guidance (DSVG) documents. Thus, in 2024-1, "Specific Device" is just a place holder to be filled in with the actual type of specific device when the template is used to create a particular DSVG.  Thus far, the MDCG has released four DSVGs using the 2024-1 template:

    • 2024-1-1 for cardiac ablation
    • 2024-1-2 for coronary stents
    • 2024-1-3 for cardiac implantable electronic devices (CIEDs), and
    • 2024-1-4 for breast implants.


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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 4.  RE: MDCG 2024-1

    Posted 14 days ago

    What Kevin says: This is a template for the MDCG, the guidances of interest for the manufacturer are the ones where the "specific device" has been filled in with a particular device/device type. This is the same approach that was used under MEDDEV 2.12/1 (with almost identical specific guidances).



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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