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  • 1.  Literature search for state of the art for CER for EU MDR

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jun-2023 09:31
    This message was posted by a user wishing to remain anonymous

    If  the Literature search for state for state of the art for similar device and alternate therapies comes up with a lot of articles , what's the ideal way to screen articles ? Can the articles with alternate therapies  which are compared to your device /similar devices be only considered ?



  • 2.  RE: Literature search for state of the art for CER for EU MDR

    Posted 26-Jun-2023 13:58

     Articles that compare alternate therapies to your device or similar devices can provide valuable insights into the effectiveness and safety of different treatment options. These studies can help establish a benchmark for your device's performance and contribute to the state of the art assessment. Systematic reviews and meta-analyses gather and analyze data from multiple studies, providing a comprehensive overview of the evidence. High-quality studies with robust methodologies are generally more valuable in informing clinical evaluation reports.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Original Message


  • 3.  RE: Literature search for state of the art for CER for EU MDR

    Posted 27-Jun-2023 03:48

    Hi Anon,

    If you get too many articles in your state of art searches you may need to refine your search strings to make them more specific. If you find that with your current search strategy most of the articles are relevant, then it may simply be that there is a lot being published in your field of interest. In that case you could consider to focus on more recent articles and/or higher quality articles to reduce the number of papers that require screening and appraisal.

    Regards,

    Wiebe



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    Wiebe Postma
    Vierpolders
    Netherlands
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    Original Message


  • 4.  RE: Literature search for state of the art for CER for EU MDR

    Posted 27-Jun-2023 04:40

    Good day Anon,

    Agree with Wiebe if there are too many articles from a search result, may need to refine the search criteria, terms used, or relationship of the disease condition.  For some devices, conducting the State of the Art search can produce hundreds and hundreds of articles, so using a methodology to further refine search terms is a good approach.  The next step is to then clearly define an appraisal process which can further refine the results of articles found.  Often times companies use the four (4) criteria with three (3) levels of appraisal which was from MEDDEV 2.7/1 Rev 3 and other sources.  Rather than using the "standard" appraisal criteria and levels, modify these to fit the state of the art against the device type considering alternative treatments or no treatments.  I often see companies struggle with this area because they have quite broad search terms and then they use the standard appraisal criteria which ends up with hundreds of articles which needs to be reviewed and analysed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Literature search for state of the art for CER for EU MDR

    Posted 27-Jun-2023 08:20

    Hello

    A couple of points to add to these excellent suggestions by colleagues -

    1. Take a look at how you are defining the state of the art (SoTA). Context matters .What is state of the art in one jurisdiction is not the same as in another jurisdiction. Be mindful of the specific details of your intended use. It is a best practice to describe your approach to SoTA in a paragraph to set the context for your technical documentation.
    2. It is ok to be broad from the viewpoint of gathering relevant information about safety aspects. 

    A quick tip - you could limit the time horizon of your literature search to make it more focused and relevant.

    Hope this helps!

    Best regards



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    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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    Original Message


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