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
Who should attend?
QA/Regulatory and R and D scientists involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe.
What will I learn?
Upon completion of this training, delegates will be able to:
- Appreciate the need for performance evaluation and how it fits into product development under the European IVD Regulation (EU 2017/746)
- Learn key definitions of performance evaluation and clinical evidence under the IVD Regulation
- Gain awareness of the scope of the European regulatory requirements for IVD clinical performance studies under the IVD Regulation
- Distinguish between non invasive and interventional clinical studies and understand requirements for vulnerable and protected study subjects
- 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
What is included?
- A loan copy of the standard for use during the course
- Gain comprehensive training notes
- Gain an internationally recognized BSI Training Academy certificate
Programme and resources
Download the course flyer
Prior knowledge and learning
Basic understanding of European IVD device regulations.
