Regulatory Open Forum

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  • 1.  Intended clinical benefit

    Posted 21-Jan-2022 13:01
    Do we need to mention the intended clinical benefit in the IFU if earlier not mentioned.
    Is it mandatory for EU MDR.
    What it is actually, and from where the reference can be taken from.

    Can we take others reference of IFU for claiming something 


  • 2.  RE: Intended clinical benefit

    Posted 22-Jan-2022 07:52
    Hello Amit

    Based on the string of questions you posted, some of which are elementary, I'd really suggest you engage a professional consultant to advise you on marketing in the MDR, and perhaps a detailed class on MDR  is appropriate for you and the company.

    Not saying this to be rude but the questions you are asking are really not going to be easily answered in the depth you might need on RAPS Forum.


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: Intended clinical benefit

    Posted 22-Jan-2022 11:03
    Thank you very much ma'am for your advice. Definately we will do that if require.

    And it was really very helpful that I got some answers in open forum for what I was looking for.

    I really thankful to all who have answered the questions raised.

    Regards,



    Original Message


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