CER (Clinical Evaluation Reports) updates - Product Codes

MDRexpert

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#1
Hello Everyone,

We are currently submitting for MDD cert for one of our products. Just before we release we realise that we can add additional product codes to the existing CER. So now we're doing a gap analysis to add the product code to the submission file as well as update the existing CER.

My question is
While doing the literature search and adding the new product code to the existing submission. Our PMS report (performed a month ago) or previous CER does not reflect this new product code in it. Do we have to update all those documents as well or is there a way to fill these gaps?

Any advise or suggestion is appreciated! Thank you.
 
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