Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

But what about our Clinical Background section?

• Can we keep our “Intended Use” and have the other information in other sections of the Instructions for Use?

• Notified Bodies want it in one clearly defined sentence or paragraph • The Intended Purpose impacts many issues: unambiguous clarity is required

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Intended purpose

A key element

Scientific Validity

Commercial Implications

Clinical Performance

Intended Purpose

Classification and Conformity Assessment

Risk Management

Liability

13/04/2023

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