Module 15 Presentations

10/04/2024

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 demonstrate sufficient access to the technical and clinical data of the equivalent device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

39

Summary

• The manufacturer is still expected to collect clinical data on the actual device, but if the equivalency argument is accepted this can be done post-market • Equivalency works well for those devices that are a modification of an existing device already marketed by the same manufacturer • The more complex the device, the harder it is to claim equivalency • High-level equivalency does not translate to low-level equivalency (remember, both are fish!) • If equivalency cannot be claimed the device can be claimed to be similar and the data leveraged for state-of-the-art and identifying safety and performance criteria

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

40