Module 15 Presentations

10/04/2024

How to present an equivalence assessment

• A template is provided in MDCG 2020-5 Annex I • The template will need to be expanded to reflect the characteristics of the devices being compared, particularly for the technical characteristics

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

37

How to present an equivalence assessment

MDCG 2020-5 Annex I • Differences need to be discussed and a scientific rationale provided as to why there is no significant difference in the safety and clinical performance

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

38