Demonstration of Equivalence in Technical Biological and Clinical Characteristics is important concluding a CER.
Question 01: Technical characteristics include Similar design, Similar conditions of use, similar specifications,
Question 02: physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms;
Question 03 : Similar operation principles, similar deployment methods and critical performance requirements
Question 04 : Biological: Is same raw materials for the equivalent device? Is similar release characteristics of substances, degradation products and leachable for the equivalent device
Question 05: Clinical: Is the equivalent device use in same clinical condition or purpose, similar severity and stage of disease, same site in the body? Is the equivalent device used in the similar population (age, anatomy and physiology), same kind of user, similar relevant critical performance as expected clinical effect for a specific intended purpose.?
Question 06: Are there sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence?