Module 15 Presentations

10/04/2024

Clinical equivalence

MDR vs MDD (MEDDEV 2.7/1 rev 4)

MDCG 2020-5 says they mean the same thing

Source: MDCG 2020-5

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

27

Clinical equivalence

Considerations: • Intended use must be the SAME •

Severity and stage of the disease must be similar; the clinical data for a device to treat the onset of a disease cannot be leveraged for a device treating the late stages of the same disease • Same site in a similar population; the 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 7

28