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  • 1.  Medical Device Incident reporting

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2020 09:07
    This message was posted by a user wishing to remain anonymous

    Hi , Could anyone advise on whats the current form used for Medical device Incident reporting  In Europe


  • 2.  RE: Medical Device Incident reporting

    Posted 27-Jan-2020 10:00
    The guidance published last fall said the new form becomes mandatory in January: https://ec.europa.eu/docsroom/documents/36292

    It's here:  https://ec.europa.eu/docsroom/documents/37348

    Although I see the main guidance page still has the older version.​

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Medical Device Incident reporting

    Posted 28-Jan-2020 01:55
    You can find the relevant guideline and reports in MEDDEV 2.12/1.

    Hope that helps

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 4.  RE: Medical Device Incident reporting

    Posted 28-Jan-2020 02:44
    Hi, you can find links on the homepage of the national competent authorities
    E.g. Germany's BfArM : 
    https://www.bfarm.de/DE/Service/Formulare/functions/Medizinprodukte/vorkommnisse/_node.html;jsessionid=84E6A72139717D38228859E1BFF6B82E.2_cid329


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    Britta Cyron
    Bochum
    Germany
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    Original Message


  • 5.  RE: Medical Device Incident reporting

    Posted 28-Jan-2020 03:00

    The forms that should be used as of January 2020 can be found here:

    https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

    See section 2.12:

    New MIR form* - as from January 2020

    New manufacturer incident report(PDF form)
    New manufacturer incident report for importing XML file* with Adobe Professional
    The published MIR form is password-protected so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house IT systems).
    You can request the password for specific authorised uses, which are subject to terms and conditions.
    New manufacturer incident report XSD file and XSL files (for implementation in manufacturer' databases)
    New manufacturer incident report help text
    Changelog file
    *If you're a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.



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    Markus Poettker
    Baar
    Switzerland
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    Original Message


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