Glossary Term
Clinical Evaluation Plan (CEP)
Definition
A Clinical Evaluation Plan (CEP) is a structured document outlining the methodology and objectives for conducting a clinical evaluation of a medical device. It defines how clinical data will be collected, analyzed, and documented to demonstrate the safety and performance of the device throughout its lifecycle, in accordance with regulatory requirements like EU MDR or FDA guidelines.
Relevance to the MedTech Industry
The CEP ensures that the clinical evaluation process is systematic, transparent, and aligned with regulatory expectations. It serves as a roadmap for gathering and assessing clinical evidence to support device approvals, demonstrate compliance, and ensure patient safety.
Additional Information & Related Terms
Clinical Evaluation Report (CER) A document summarizing the findings of the clinical evaluation process, based on the CEP.
Post-Market Clinical Follow-Up (PMCF) Activities defined in the CEP to gather data after the device is on the market.
Risk Management File Integrates with the CEP to address clinical risks identified during evaluation.
EU MDR Sets specific requirements for the creation and implementation of a CEP.