Clinical evaluation assessment report (CEAR)

The CEAR is written by the notified body, not the manufacturer. MDCG 2020-13 gives its template, which also shows manufacturers what reviewers will check in their clinical evaluation report.

A clinical evaluation assessment report (CEAR) is a 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 – a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).

MDCG 2020-13, Introduction