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:
Sent: 11-Aug-2023 07:48
From: Anonymous Member
Subject: CER , CEP -MDR
This message was posted by a user wishing to remain anonymous
Do the sections under the CEP need to be repeated under the CER ?