Module 14: Design Development and Certification of Medical Devices

17/11/2023

Assess Available Information

 Weight of Evidence Approach

● Physicochemical properties: is it likely to penetrate skin? ● Are there any epidemiological data? ● Is it a pharmaceutical ingredient, cosmetic ingredient or food additive? ● Do closely similar substances exist for which there are data? – “Read-Across”

The Organisation for Professionals in Regulatory Affairs

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If no data ..

The Organisation for Professionals in Regulatory Affairs

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