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  • 1.  Population for performance studies under the IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 19-Dec-2022 11:45
    This message was posted by a user wishing to remain anonymous

    Hi all,

    Do manufacturers need to collect European population in performance studies under the IVDR? If we perform a performance study with specimens collected outside Europe for a disease with a small number of cases in Europe, will the performance study data be accepted if we can provide a scientifically valid justification that there are no racial differences for the disease?

    Any feedback would be appreciated.

    Best regards,


  • 2.  RE: Population for performance studies under the IVDR

    Posted 20-Dec-2022 03:53
    Hi,

    That is quite a tricky situation. Let us understand this:

    According to IVDR:
    Clinical performance
    The ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

    MDCG 2022-2 : Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)-

    The clinical performance aims to demonstrate that the IVD can achieve clinically relevant outputs through predictable and reliable use by the intended user(s). The manufacturer should demonstrate that the IVD has been tested for the intended use(s), target population(s), use condition(s), operating- and use environment(s) and with all the intended user group(s).

    So, you see, target population, intended user, usage conditions and environment has to be identical to make your data from outside EU population acceptable. Generally such data is considered "other sources of clinical performance data". 

    Hope this clarifies
    Best

    ------------------------------
    Rahul Pandey
    PhD
    Lucknow
    India
    ------------------------------

    Original Message


  • 3.  RE: Population for performance studies under the IVDR

    Posted 20-Dec-2022 07:05
    Hello,  
    In some cases, I've seen a justification acceptable for using a non-EU population for IVDR performance studies. The justification, however, should not only be based on race. A stronger argument would be made if, in addition to similar patient demographics between the study sample and the EU population, you can also show similar prevalence and similar standards of care related to the intended purpose of the IVD.

    Best,

    ------------------------------
    Bethany Chung
    Olney MD
    United States
    ------------------------------

    Original Message


  • 4.  RE: Population for performance studies under the IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 21-Dec-2022 07:48
    This message was posted by a user wishing to remain anonymous

    Hello Rahul and Bethany,

    Thank you very much for your kind reponse including the information on the relevant definition and MDCG guideline. I will consider the issue that I raised based on the feedback you provided.

    Best regards,
    Original Message


  • 5.  RE: Population for performance studies under the IVDR

    Posted 21-Dec-2022 06:11
    Hello there,

    It depends where your data is from and if it meets the European standards. EMA is not very flexible so it is worth checking with them before preparing submission. UK MHRA is another option to check as they are quite open to using data from different regions but again it is a good idea to ask them.

    Have a great day.
    Olga

    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: Population for performance studies under the IVDR

    Posted 21-Dec-2022 11:44
    If you look at the views provided under the Performance Evaluation Consultation Procedure for high risk IVDs, you see in a number of cases where the expert panels found fault with the populations used for studies. Frequently, it was because the sponsor didn't justify the use of non-European populations and how they apply to European populations.

    So while the use a non-European population isn't out of the question, if you do, you should have a robust rationale for how the population used applied to the European population.

    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------

    Original Message


  • 7.  RE: Population for performance studies under the IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 23-Dec-2022 07:43
    This message was posted by a user wishing to remain anonymous

    Hi Corey,

    Thank you for providing the very informative link and your feedback.

    I will take a close look at the views and consider the validity of the population subject to the clinical performance study of our device.

    Best regards,
    Original Message


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