Module 15 2022

19/05/2022

Clinical Performance versus Clinical Benefit

Examples Clinical Performance

Clinical Benefit

Dressing

Reduction in wound size

Wound healed, pain reduction

Hip implant

Increased Range of Motion QOL score e.g. Return to work

Stent

Increase in vessel patency Survival, QOL score

Example

Clinical Performance

Indirect Clinical Benefit*

Enables an implant to achieve its intended purpose

Guidewire Accurate placement

*MDCG 2020-5

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

9

Equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

10

5