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  • 1.  IVDR - application for performance studies

    This message was posted by a user wishing to remain anonymous
    Posted 20-Mar-2023 15:41
    This message was posted by a user wishing to remain anonymous

    Hello,

    A companion diagnostic is being co-developed with a therapeutic product to support marketing authorization of both products in the EU. Specimens will be collected in specific EU countries, but testing of specimens will occur in non-EU countries. Do we need to submit an application for the device performance evaluation study in EU Member States where specimens will be collected?

    Thank you



  • 2.  RE: IVDR - application for performance studies

    Posted 21-Mar-2023 04:49

    Good day Anon,

    Your question is a bit more complex in regard to clinical investigations associated with companion diagnostics and the associated performance studies; you probably would need to get some more expert opinion.  The simple answer is probably yes, the performance study would need to be registered in any country where specimens are collected.  Though depending on how the specimens are being collected, relationship to the medicinal product (therapeutic product), and how results are being reported could have an impact.  In addition, with the Clinical Trials Regulations (CTR) also depends on whether using this process or not and how related to the clinical study of the therapeutic product.  But fundamentally, if patient specimens are being collected prospectively from patients, Good Clinical Practices (GCP) are needed, so patients need to be made aware what their specimen is being used for, how reporting is done, and security of information.



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


  • 3.  RE: IVDR - application for performance studies

    Posted 21-Mar-2023 04:54

    Hello,

    Yes, you will need to submit application to the country where you will be collecting specimens. It depends on the level of intervention you may need to submit to Ethics Committee only and not need competent authorities approval, which could speed up the process. But again this depends on the data that you will need.

    Have a good week.

    Olga



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


  • 4.  RE: IVDR - application for performance studies

    Posted 21-Mar-2023 18:21

    This is somewhat tangential, but these survey results from EFPIA are interesting and related to questions of whether a PSA is needed (I don't work for EFPIA) https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/new-european-legislation-designed-to-protect-patients-is-delaying-clinical-trials-for-thousands-of-people-with-cancer-and-rare-diseases/



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    Corey Jaseph RAC
    Senior Research Analyst
    Morongo Valley CA
    United States
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    Original Message


  • 5.  RE: IVDR - application for performance studies

    Posted 22-Mar-2023 05:05

    You also need to keep the GDPR 2016/679, especially when analyzed outside of the EU. Depending on the type of specimen, Blood/DNA is sensitive personal data, so you need n informed consent from the subjects the specimen is collected from.



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    Andrea Offer
    Meerbusch
    Germany
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    Original Message


  • 6.  RE: IVDR - application for performance studies

    Posted 22-Mar-2023 14:35

    Hi,

    Yes, if you are conducting a device performance evaluation study in EU Member States where specimens will be collected, you will need to submit an application to the relevant national authorities in those countries.

    This is because the collection of specimens for use in a device performance evaluation study is considered to be a clinical investigation, which must comply with the requirements of the Clinical Trials Regulation (CTR) (EU) 536/2014 and other relevant EU and national regulations.

    The application for the device performance evaluation study should include information on the study design, the investigational device, the study population, and the informed consent process. The application should also include details on the sponsor of the study, the site(s) where the study will be conducted, and the qualifications and experience of the investigators.

    It is important to note that the application process may vary between EU Member States, so you should consult the relevant national authorities in each country where the study will be conducted to obtain guidance on the application process and any additional requirements.

    Additionally, you should ensure that the study complies with the requirements of the IVD Regulation (EU) 2017/746 for the companion diagnostic, as well as any other applicable regulations for the therapeutic product.



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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
    ------------------------------

    Original Message


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