Post-Market Clinical Follow-up Report (PMCFR) Template

Description

This Post-Market Clinical Follow-up Report (PMCFR) Template is specifically designed to be used in conjunction with the Post-Market Clinical Follow-up Plan (PMCFP) Template, and intended for straightforward transfer of information from the PMCFP to the PMCFR.

The sections of this PMCFR Template include all the fundamental components of an EU MDR 2017/745-compliant PMCFR. Moreover, 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) 2020‑8 recommendations conforming to the expectations by the Notified Body (NB). This enables content of the finalized PMCFP to be directly copied into the equivalent sections of the associated PMCFR Template, with only minor modifications as instructed throughout.