What is the webinar about?

The webinar presents an overview of the key aspects of IVDR compliance, focusing on the common pitfalls related to the technical documentation and Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). The webinar is tailored to SMEs in the IVDR space that are starting their IVDR implementation journey.

Who should attend?

All SMEs who intend to apply for CE marking under the In Vitro Diagnostic Regulation. This webinar will offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have experience of working with a notified body.

What will participants gain?

Join this insightful extended webinar to hear subject matter experts, Alex Laan, BSI’s Head of IVD Notified Body and Liz Harrison, Global Head of IVD, talk about the key IVDR changes and lessons learnt so far, as well as tips on preparing a comprehensive Technical Documentation and the Performance Evaluation requirements under the IVDR. You will also gain a better understanding of the status related to high-risk CDx & Class D devices.

The webinar will include:

• History Lesson: Key IVDR changes… why and when?
• Telling a Story: Creating effective technical documentation
• Clinical Evidence: Understanding the requirements
• High Risk update: Current status of CDx & Class D devices
• Q&A sessions with panel