Clinical Evaluation Report
Clinical Evaluation Report · clinical evaluation report
The structured EU MDR document evaluating all clinical data — own and equivalent — to demonstrate a device's clinical safety, performance, and benefit-risk profile.
A Clinical Evaluation Report (CER) is required under EU MDR Annex XIV for every device. It systematically reviews the device's own clinical investigations, equivalent-device data, and published literature against the device's intended purpose, hazards (per ISO 14971), and state of the art. The CER is alive: PMS, PMCF and complaint data update it across the device's life.
V5 keeps CER inputs (literature search, complaint analysis, PMCF data, risk file) linked, so a CER update is a refresh rather than a rebuild.
- EU MDR Annex XIV Part A
- MEDDEV 2.7/1 rev 4
Free trial, no credit card, onboard in days, not months.