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?
3 thoughts on “Technical Biological and Clinical Characteristics”
A well-established medical device with approved regulatory status from another manufacturer can be considered to be an equivalent device to the medical device undergoing clinical evaluation, if the two devices have comparable technical, biological and clinical characteristics. If the two devices are found to be comparable, then the technical documentation of the equivalent device can be used to prove the clinical safety and performance of the device under evaluation.
The two devices are said to be technically comparable if they have similar design, principle of operation and specifications, and are used under similar conditions. They should also have similar physicochemical properties, deployment methods and critical performance requirements.
To claim biological equivalence, the devices should have the same substances or materials in contact with same human tissues or fluids. The duration of contact and the release characteristics should also be similar. This means the raw materials used in both medical devices should not cause any significant difference in the clinical performance and clinical safety.
The device under consideration and the well-established device should be used for the same medical indication at a similar severity and stage of disease, and have the same intended use. Both devices should also be used on the same body site and deliver similar performance. The devices should also be used on the same patient population considering factors like age, gender, anatomy, physiology etc.
The well-established device is considered as an equivalent device only if it matches the technical, biological and clinical characteristics of the device under evaluation.
But, as per Medical Device Regulation (EU) 2017/745 Article 61, Clause 5, to claim a medical device to be an equivalent device, a contract should be in place between the manufacturer of the CE marked device on the market and the manufacturer of the device undergoing clinical evaluation, which allows the manufacturer of the second device full access to the technical documentation on an ongoing basis and the original clinical evaluation should have been performed in compliance with the requirements of MDR. The data available in the absence of a contract might not be sufficient to demonstrate equivalency.
To establish any equivalent device manufacturer has to clearly demonstrate that they have “sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence” Exactly what constitutes sufficient levels of access is not clearly defined but as through perspective of MEDEV requirements for measurements, pre-clinical study reports, and knowledge of special manufacturing treatments. The notified bodies are likely to insist that manufacturers either to have access to the technical documentation for any claimed equivalent, regardless of class, or be able to perform their own comparative testing on the two devices.
MDR Article 61 states, Clinical Investigation can be exempted to conclude CER by providing Demonstration of Equivalence.
To prove the conformity of device under evaluation with relevant safety and performance requirements, using equivalent device, a contract shall be in place between two manufacturers to have full access of its technical documentation (with earlier proved compliance with regulation requirements)
As per ANNEX XIV, Part A, for demonstration of equivalence, Clinical, technical and biological characteristics will be taken into considered as
• The subject device should be tested for same disease, intended purpose, duration of use, at the same site in body and in same user group (age, gender, severity etc) of the equivalent device for which it is marketed for clinical characteristics.
• Design, conditions of use, specifications, properties including physiochemical properties (energy intensity, viscosity, surface characteristics, tensile strength, wavelength and software algorithms) principles of operation, deployment methods, safety and performance requirements should be same for technical characteristics
• Same use of materials with same human tissue or fluids contacts, same contact duration and release characteristics considering biological safety without causing much difference in clinical performance for biological characteristics