Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The Organisation for Professionals in Regulatory Affairs

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• Significant upward shift of classification • Many IVDs will jump from a general (low risk device) to a class B or C • Increase in classification will result in: • Increased NB interaction • Greater level of technical documentation required • Increased surveillance

Additional Notified Body costs Decreased Notified Body availability Technical Documentation remediation

The Organisation for Professionals in Regulatory Affairs

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