Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Intended Purpose – Commercial implications

• Tension between Regulatory Affairs and Sales & Marketing • Formulating an “easy” Intended Purpose for compliance may interfere with commercial interests. • E.g. disclaimers for Cancer (see hCG)

Scientific Validity

Commercial Implications

Clinical Performance

Intended Purpose

Risk Management

Classification

Liability

www.qarad.com

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Intended Purpose and Liability

The Intended Purpose contains claims. The IFU contains disclaimers for foreseeable misuse. This delineates your liability and defines what is off-label use.

Scientific Validity

Commercial Implications

Clinical Performance

Intended Purpose

Risk Management

Classification

Liability

www.qarad.com

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