Module 15 2022

19/05/2022

How to present an equivalence assessment

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

35

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 5

36

18