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: Utilization of the same materials or substances in contact with similar human tissues or body fluids duration as well as way of contact with the subject.

All three qualities, biological, clinical, as well as technical, require to be wholly appraised while demonstrating equivalence.

For Considering Equivalence

All three characteristics (clinical, technical, biological) are required to be fulfilled.

Equivalence may only be based on a single device. 

The manufacturer must examine if the medical device presumed to be equivalent has been manufactured via a unique treatment (like a surface adaptation, a procedure that modifies material characteristics); if this is the case, the treatment could cause differences in respect to technical as well as biological characteristics; this should be taken into account for the demonstration of equivalence.

If measurements are feasible, clinically applicable properties and specifications should be measured both in the device under evaluation as well as the device presumed to be equivalent, and presented in comparative tabulations; Comparative drawings or pictures should be included in order to compare shapes as well as sizes of elements that are in contact with the body.

When Medical Device Literature Search Protocol Required?

The Medical Device Literature Search Protocol is a key part of the clinical evaluation. It typically involves numerous hours of work. Manufacturers collect together scientific articles, among other reasons, to document the state of the art and offer evidence of the security, performance, as well as clinical advantage of their device In the literature search. In agreement, the MDR mentions literature searches as a basis of information in the clinical evaluation, pre-clinical evaluation, as well as post-market surveillance phases.