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  • 1.  MDR submissions types

    Posted 17-Apr-2023 05:16

    Hello,

    Can you please advise the difference between dedicated and standard MDR submission to the notified bodies?
    Thank you



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    Youmna Abboud
    Beirut
    Lebanon
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  • 2.  RE: MDR submissions types

    Posted 18-Apr-2023 15:05

    Hello Youmna,

    Not sure exactly the context, but assuming a dedicated like expediated and standard EU MDR submission.  Basically the difference is dedicated is quicker (not sure so much quicker) and definitely more expensive.  You can get quotes for the two and warning in advance to not be shocked at the cost of a dedicated submission process.



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


  • 3.  RE: MDR submissions types

    Posted 19-Apr-2023 11:54

    Richard has answered perfectly, but to respond with slightly different words, "dedicated" means the Notified Body will dedicate reviewers to your submission immediately, whereas with "standard," reviews will be conducted as a normal part of business that includes reviews from other clients. 



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


  • 4.  RE: MDR submissions types

    Posted 20-Apr-2023 01:43

    Thank you both for the clarification!



    ------------------------------
    Youmna Abboud
    Beirut
    Lebanon
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    Original Message


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