Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

How to Classify your product ?

• What is the intended use of the product?

• How does the product achieve these claims? “Primary Mode of Action”

• What scientific data is available to support the primary mode of action?

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Public

Guidance on Classification

Borderlines and Classification MDCG Group

Provides definitions of pharmacological, metabolic and immunological Includes details on the borderline with medicinal products including herbal products Details some clarification on Rule 21 “substance based” devices

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