Theme Clinical evaluation
Target audience Notified Bodies
Products concerned MD
Regulatory references MDR (EU) 2017/745

Article 61

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.