Clinical Evaluation Report (CER) Template

Description

This Clinical Evaluation Report (CER) Template is specifically designed to be used in conjunction with the Clinical Evaluation Plan (CEP) Template.

The sections of this CER Template include all the fundamental components of an EU MDR 2017/745-compliant CER. The structure and sections as well as their order and content follow the MEDDEV 2.7/1 Rev. 4 guidelines and Medical Device Coordination Group (MDCG) 2020‑6 and MDCG 2020‑13 recommendations conforming to the expectations by the Notified Body (NB).