|Target audience||Notified Bodies|
|Regulatory references||MDR (EU) 2017/745
Annex VII section 4.5.5
This document presents a template of a clinical evaluation assessment report (CEAR). This is the report used by the Notified Body to clearly document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the Clinical Evaluation Report (CER) and the related clinical evaluation that was conducted.
Although addressed to Notified Bodies, this document is an excellent indirect tool for manufacturers to identify the points of attention verified by Notified Bodies during the conformity assessment of technical documentation, and in particular clinical evaluation.