Regulatory Open Forum

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  • 1.  Sponsor Label Details

    Posted 15-Mar-2021 06:44
    Hi All,

    I am currently looking at new countries to market our class II device and I was wondering how people are handing / preparing to handle sponsor requirements. Under the MDR, the authorised representative details need to be accessible to users of the device, Austalia (TGA) also request this. I am guessing other countries will also require this information.

    Let's say, we sell in four different countries, there are potentially four sets of sponsor details to include in the IFU for instance. Has anyone else come across this? Are there any helpful tips? 

    Thanks.

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    James
    Head of QARA
    UK
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  • 2.  RE: Sponsor Label Details

    Posted 16-Mar-2021 04:32
    Edited by David Clafton 16-Mar-2021 04:32

    Hello,

    I've seen IFUs with many of the country rep details in the same document. I've also seen separate ones for each country/area. I've also seen ones where the rep details are on a separate document.

    Obviously the proposed country rep can advise on what's acceptable for the country they are representing. Some countries may not require it for software, worth checking.

    I would also say it depends on how often the IFUs/labels/wherever the details are need to be updated.

    Hope this helps.

    David



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    David Clafton
    United Kingdom
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  • 3.  RE: Sponsor Label Details

    Posted 17-Mar-2021 03:09
    Thanks for the info Dave. Have you seen the details on the software also, the splash screen for example?

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    James
    Head of QARA
    UK
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  • 4.  RE: Sponsor Label Details

    Posted 17-Mar-2021 06:59
    They usually just talk about on the label, which is always interesting for software.

    If you were to define the product label as IFU+splash/about screen, then in theory just the IFU will do.

    Not had a problem with that so far.

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    David Clafton
    Oxford
    United Kingdom
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