A clinical evaluation plan is a detailed document that outlines the systematic approach and strategy for evaluating the clinical performance and safety of a medical device. It serves as a roadmap for conducting clinical evaluations throughout the device’s lifecycle, from initial development to post-market surveillance.
The clinical evaluation is an essential part of the regulatory submission process, providing evidence to demonstrate the device’s safety, performance, and compliance with regulatory requirements. The purpose of a clinical evaluation plan is to gather and assess clinical data to support the device’s safety and efficacy claims. It involves a comprehensive analysis of existing scientific literature search protocols, clinical investigations, post-market surveillance data, and other relevant sources of clinical evidence. The clinical evaluation plan helps establish the scientific validity, clinical performance, and risk-benefit profile of the medical device.
To develop the scope of the medical device clinical evaluation to be conducted, as well as to plan a sound method for identifying, collecting, and analyzing clinical data with the proper schedule and clinical evaluation team.