MDCG 2020-13 clinical evaluation assessment 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).

You can download the clinical evaluation assessment report (CEAR) here.