Is the Clinical Evaluation Plan the best place to document our position on our CER approach and gain alignment with the Notified Body as needed?

Yes, the plan lays out your overall approach. Per MEDDEV 2.7.1 Rev. 4, there are five stages to clinical evaluation planning. The first four define the scope, identify the pertinent data, have someone ensure the data’s scientific validity and clinical relevance, then analyze the data. Finalizing the clinical evaluation report (CER) is the last step in clinical evaluation. CERs themselves have a section on approach and criteria. So, we think CER approach is covered as part of the process and in the actual CER.