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  • 1.  CER , CEP -MDR

    This message was posted by a user wishing to remain anonymous
    Posted 11-Aug-2023 09:03
    This message was posted by a user wishing to remain anonymous

     Do the sections under the CEP need to be repeated under the CER ?



  • 2.  RE: CER , CEP -MDR

    Posted 14-Aug-2023 05:02

    Hello Anon,

    This can be a contentious question as there are many differing views on the content of the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) having repeated information in the CER.  Myself personally, I do not see the need to repeat information from the CEP into the CER because if the CEP is already a controlled document in the quality system - then the information is available.  Plus if there is the same information in both the CEP and the CER ... then if something changes, have to make sure it is the same in both.  However, and unfortunate or not, we have seen Notified Bodies want repeated information in both (makes their review easier rather than flipping between documents or remembering information) which can be frustrating.  My recommendation is start with a "non-repeat" version and then see how it goes with your Notified Body review, hopefully they are fine looking through different documents.



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


  • 3.  RE: CER , CEP -MDR

    Posted 15-Aug-2023 00:50
    Hi Anon,

    I have written quite a few CEPs now and I have ended with somewhat of a compromise. I now like to see some of the tables repeated as it helps readers/reviewers/regulators see alignment (also helps ensure both documents have been kept up to date). Such tables may include ‘GSPRs’ (and how you’ll meet them with your clinical data), ‘Clinical Benefits/Claims’, tables demonstrating target goals versus acceptance criteria. This process will also help if you have different people updating the CEP bs CER over time. I’d love to hear other peoples opinions.


    Original Message


  • 4.  RE: CER , CEP -MDR

    Posted 15-Aug-2023 09:03

    Anon,

    Also, please consider the time that it takes to review a CER if the reviewer has to keep looking up information in the CEP. You are paying for this reviewer's time and the easier it is to find the CEP information by repeating it in the CER will save you unnecessary costs.

    Regards,



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    John Minier, RAC
    Consultant, Principal
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    Original Message


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