Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 Risk Management Reporting  Review of process with respect to plan  Top management acceptance of process implementation  Overall risk statement

 Is the product safe and effective?

 Is there benefit of having device on market?

The Organisation for Professionals in Regulatory Affairs

29

Post-Production Activity

 Post Market Surveillance • Continuous assessment of the risk-benefit of the device • Complaints • Design Changes • Takes into account customer feedback, state of the art • Beware accumulative design changes and impact of residual risk

The Organisation for Professionals in Regulatory Affairs

30