Literature Search - Notified Body Had Questions About our Rationale
We have submitted our Clinical Evaluation Report to our notified body, and they came back with some cryptic feedback we're not quite sure what to make of it.
We're taking the literature review approach, compliant to MEDDEV. 2.7.1 Rev.3.
The main issue focuses on our Rationale for the Selection. They said the detailed description of different stages of literature search (including identification, appraisal, analysis and conclusion of hits were not available.
We felt we did address this, so I guess I'm reaching out to hear what others have done for this. Perhaps we simply were not thorough enough, or didn't have enough citations? What are others doing to provide rationale for their selection? Does anyone have any examples they're willing to share?