Module 15 Presentations

10/04/2024

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

Increasein 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