Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

General Principles

 Risk ● Commination of the likelihood

of harm occurring and how severe the harm could be.

Probability of Occurrence

Hazard

● For harm to occur there must be a single or multiple series of events where hazards could cause harm. ● Not all hazards will lead to harm ● Not all hazardous situations lead to harm

Harm

Risk

Severity of Harm

Hazardous Situation

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Risk Analysis

 Risk analysis is an iterative process and  It will become more granular and focused as greater experience is gained relating to the device during design and development and post market.  Risk evaluation should be estimated initially with continuous review and justification applied when additional data (and knowledge is available)  Consider existing sources of data available to you, including from similar devices, as long as you take into account the intended purpose

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