Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Post-Production Activity

 Vigilance  Significant changes in the risk-benefit would result in a potential reportable case  Current and active risk management VERY important to determining this  Can provide basic framework for when to report incidents

The Organisation for Professionals in Regulatory Affairs

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IVD Risk Management

 Pathway is more complex for IVDs  Can be difficult to identify, assess and mitigate risk

Medical Device

Manufacturer

Patient

Physician / Decision Maker

Laboratory/ Operator

Manufacturer

Patient

IVD

The Organisation for Professionals in Regulatory Affairs

32