Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

General Principles

 Harm ● Physical injury or damage to the health of people or damage to property or the environment  Hazard ● Potential source of harm  Hazardous Situation ● Circumstance in which people, property, or the environment are exposed to one or more hazard(s)  Risk ● Combination of the probability of occurrence of harm and severity of that harm

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General Principles

 Hazard ● Any design characteristic that impacts safety and performance resulting in a deficiency of the device ● Any environmental factor ● Foreseeable or unforeseeable ● May result in direct or indirect harm

 E.g. Electromagnetic energy, thermal energy, biological contamination

The Organisation for Professionals in Regulatory Affairs

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