Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 Risk Control  Appropriate for reducing risk  Implementation of control in order

1. Safety by design

2. Protection mechanisms

3. Safety information and training

 As low as reasonably possible  (ALARP – removal of economic consideration)

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Practical Implementation

 Risk Benefit  As low as possible still have some residual risk  Each residual risk must be evaluated against the benefit of using the device  Risk Benefit is continuously changing based on post market data  Overall risk acceptability

State of the Art

Intended Purpose

Clinical Benefit

Intended Use

Residual Risk

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