Course Aim

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.

Course Description

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.

On-demand - training that’s even more flexible

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

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

What will I learn?

Upon completion of this course, you’ll be able to:

• Appreciate the need for performance evaluation and how it fits into product development under the IVD Regulation
• 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

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.

How will I learn?

This is an online, interactive on-demand course. 

Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.

You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue

During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Basic understanding of European IVD device regulations.

Modules

• Module 1 - The background to the IVDR
• Module 2 - Performance evaluation plan and scientific validity
• Module 3 - Clinical evidence – Analytical performance
• Module 4 - Clinical evidence – Clinical performance and the Performance Evaluation Report
• Module 5 - Annex XIII clinical performance studies, and the requirements of Annex XIV
• Module 6- Bias in clinical performance studies and practical and administrative considerations
• Module 7 - Post-market performance follow-up and planning