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

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?

On completion of this training, participants will:

• 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

What is included?

• You will gain 8 CPD points on completing the course
• Training course notes
• Certificate