Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)
When placing an IVD device on the European market, you must demonstrate that it complies with necessary regulatory requirements through appropriate conformity assessment procedures. Learn how to plan for appropriate performance studies for your IVD device and gather required information and data needed for a body of clinical evidence under the proposed future IVDR.
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:
- Grasp key definitions of performance evaluation and clinical evidence, including what is expected under the proposed future IVDR
- Plan and document clinical evidence under the proposed future IVD Regulation, with an appreciation of how this information should be maintained
- Apply practical considerations for study design and protocols
- Appreciate performance evaluation and how it fits into IVD product development under the current European IVD Directive
- Discover how the European regulatory requirements for IVD clinical performance studies and clinical evidence will change with the future IVDR
What is included?
- You will gain 8 CPD points on completing the course
- Training course notes
- Lunch and refreshments