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  • 1.  Clinical Trial in EU Countries

    Posted 25-Jan-2016 20:42

    Hi All,

    Recently we been exploring the clinical requirements in EU countries and found out one of the clinical study application required document is essential requirement checklist. As far from what i understand, clinical data will be part of essential requirement checklist to fulfill the requirements of Annex X of MDD.

    I have several doubts as listed below, feel free to comments:

    1. Are we allow to submit a draft version of essential requirements checklist, with all the requirements fulfill for manufacturing and product compliance, except for clinical trial data for clinical trial study application in EU countries?
    2. is there anyway to maneuver this requirement with other equivalent document?

    Appreciate your time.

    Thank you.

    Regards,

    ------------------------------
    Winson
    Regional Regulatory Affairs Executive
    Becton Dickinson
    Singapore
    ------------------------------


  • 2.  RE: Clinical Trial in EU Countries

    Posted 26-Jan-2016 00:02
    Winson,

    Q1: Are we allow to submit a draft version of essential requirements checklist, with all the requirements fulfill for manufacturing and product compliance, except for clinical trial data for clinical trial study application in EU countries?

    A to Q1: Yes

    Q2: is there anyway to maneuver this requirement with other equivalent document?


    Please be noted for the following: 

    Your signed statement under MDD Annex VIII 2.2 constitutes "device meets all of the relevant essential requirements, other than those subject to the investigation."  

    Accordingly, the manufacturers must therefore ensure that at the time a notification is made to the CA (e.g., MHRA), they have all documentation required to demonstrate conformity with the relevant essential requirements available for submission to the CA (e.g, MHRA) when requested.

    One of the most common deficiencies reported is "incomplete documentation."

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 3.  RE: Clinical Trial in EU Countries

    Posted 26-Jan-2016 10:23
    Hi Winson,

    The expectation for a pre-clinical essential requirements checklist is that you complete the checklist to the extent possible given the lack of clinical data.  That is, you want to show how the device meets all of the essential requirements, except for those that require clinical data.  So your ER checklist would reflect things like risk management, device testing (bench and animal), biocompatibility testing, sterilization validation, etc. 

    Julie

    --
    Julie N. Broderick, RAC
    Broderick Regulatory Consulting, LLC
    P.O. Box 903
    Winchester, MA 01890
    Tel: 781-254-5094



    Original Message


  • 4.  RE: Clinical Trial in EU Countries

    Posted 03-Feb-2016 02:52

    Why would this be a "draft"?  I would release it as Version x, perhaps with the clinical trial listed as pending or planned. Later, when the trial is completed, I would add the trial to the checklist and release Version x+1.  Then, the next time the EU revises the Essential Requirements, you will release Version x+2.

    ------------------------------
    Julie Omohundro RAC
    Durham NC
    United States

    Original Message