Module 15 2022

19/05/2022

How to present an equivalence assessment

MDCG 2020-5 Annex I • Differences need to be discussed and a scientific rationale provided as to why there is no significant difference in the safety and clinical performance

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

37

Summary

• Equivalence can be used to leverage clinical data from one device to support compliance of another • Equivalency is demonstrated by comparing technical, biological, and clinical characteristics • Equivalency with multiple devices can be claimed but equivalency for each must be demonstrated in full • Differences must be justified to demonstrate that they result in no clinically significant difference in the safety and clinical performance of the device • Consider requirements that must be the SAME and those that can be SIMILAR • The manufacturer must have sufficient access to the technical and clinical data of the equivalent device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

38

19