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
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