Glossary Term
Clinical Evaluation Report (CER)
Definition
A Clinical Evaluation Report (CER) is a comprehensive document summarizing the clinical evaluation of a medical device. It details the analysis of clinical data to demonstrate the device’s safety, performance, and compliance with regulatory requirements, such as those outlined in the EU Medical Device Regulation (EU MDR) or In Vitro Diagnostic Regulation (IVDR).
Relevance to the MedTech Industry
The CER is critical for securing and maintaining market approval for medical devices in regions like the European Union. It provides evidence that the device meets regulatory expectations, addresses patient safety, and delivers its intended clinical benefits.
Additional Information & Related Terms
Clinical Evaluation Plan (CEP) The document that outlines the methodology and scope of the clinical evaluation, leading to the CER.
Post-Market Clinical Follow-Up (PMCF) Data incorporated into the CER to ensure continued device safety and performance.
EU MDR Specifies the mandatory inclusion of a CER in the conformity assessment process for medical devices.
Risk Management File Integrates with the CER to address clinical risks identified during evaluation.