Module 15 2022

19/05/2022

Clinical equivalence

Considerations: • Intended use must be the SAME •

Severity and stage of the disease must be similar; clinical data for a device to treat the onset of a disease cannot be leveraged for a device treating the late stages of a disease • Same site in a similar population; clinical data for a device suitable for adults cannot be leveraged for children and vice versa • Same kind of user; clinical data for a hospital based device cannot be leveraged for a home based device • Has similar relevant critical performance; if the equivalent device is no-longer state-of the-art its data for clinical performance cannot be leveraged

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

27

Specific requirements for equivalence: Implantable and Class III devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

28

14