Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)

To provide an understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe, this intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

How will I benefit?

This course will help you:

  • Learn what an In Vitro Diagnostic is and what is required to demonstrate performance according to the IVD Regulation
  • Appreciate what the design and development stages are during IVD product development
  • Understand the definitions of performance evaluation that incorporate clinical evidence under the In Vitro Diagnostic Regulation
  • Identify the analytical performance studies required
  • Explore clinical performance studies including the legal and regulatory requirements and practical considerations
  • Document clinical evidence and maintain the documentation throughout the life cycle of the product