Module 14: Design Development and Certification of Medical Devices

17/11/2023

Identify leachable substance

Evaluate exposure, duration and route

Collect and evaluate toxicity data

Do adequate data exist?

NO

YES

Obtain data, conduct evaluation

Determine acceptable levels

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Biological Evaluation Report - 1

 No specific guidance

Introduction

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• Categorisation of Medical Device

ABC Cream is categorized as a surface-contacting device to be used exclusively on the skin. The duration of contact is most likely to be that defined by limited exposure (total not exceeding 24 hours).

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