Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Clinical Performance & Clinical Benefit

The WHY?

N.B. ‘Clinical Claims’ are claims made by the manufacturer in relation to clinical performance and clinical benefit. Clinical Claims need to be based on ‘clinical data’.

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The Organisation for Professionals in Regulatory Affairs

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Your Clinical Evidence (i.e. ‘your clinical data and evaluation’ ) defines your Intended Purpose/Indications.

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The Organisation for Professionals in Regulatory Affairs

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