Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)
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 both the IVD Directive and Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.
Who should attend?
- Quality assurance or regulatory personnel
- R&D scientists involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe
It is beneficial to have a basic understanding of European IVD device regulations
What will I learn?
Upon completion of this training, delegates will be able to:
- Appreciate performance evaluation and how it fits into IVD product development under the current European IVD Directive (98/79/EC)
- Grasp key definitions of performance evaluation and clinical evidence, including what is expected under the IVD Regulation (EU 2017/746)
- Appreciate how the European regulatory requirements for IVD clinical performance studies and clinical evidence have changed with the IVDR
- Apply practical considerations for study design and protocols
- Plan and document clinical evidence under the IVD Regulation; with an appreciation of how this information should be maintained throughout the product lifecycle
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 Directive
- Appreciate what the design and development stages are during IVD product development
- Understand performance evaluation under the IVD Directive and 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