Clinical Evaluation Report - Demonstration of Equivalence
Utilizing clinical data as well as clinical evidence from equivalent devices allowed manufacturers to save time and keep away from redundant clinical investigations. Medical device manufacturers utilized clinical data from equivalent devices to verify the clinical performance and protection of their devices. Technical, Clinical, as well as biological characteristics, shall be taken into consideration for the demonstration of equivalence . Clinical : Similar in clinical condition, severity, and stage of illness, user, clinical effect as well as patient’s characteristics (e.g. age, physiology, gender, weight). Clinical characteristic is utilized for the same clinical condition (including while applicable similar severity and stage of disease, same medical indication), as well as the similar intended purpose. Technical : Similar in design, procedure, specifications, properties, deployment techniques, principles of operation as well as vital performance requirements. Biological : Utilizat