Event
Meeting
IVD
25 November - 18 December, 2025 - 13:16 - 13:16 (CET)
Online Event
Date: Wednesday, 17 December 2025
Time: 12h00 to 13h00 (CET)
Location: Zoom webinar
Register in advance: Click here or scan the QR code
After registering, you will receive a confirmation email with details on how to join the webinar.
About the webinar
Background
In 2024, WHO launched a public consultation to gather feedback from manufacturers on proposed changes to prequalification assessment of IVDs. These changes aim to establish more agile prequalification assessment process, improve responsiveness and support regulatory convergence efforts so that the growing number and diversity of IVD applications can be effectively assessed. As an outcome of this consultation, a new WHO prequalification assessment procedure will come into effect on 1 January 2026.
Webinar objectives:
Participants will receive an overview of the planned changes and implementation, including:
- WHO’s performance evaluation becomes a prerequisite and a separate step to prequalification assessment for specific IVD categories
- Updated components of WHO’s prequalification assessment
- Expanded use of the risk-based approach and reliance as part of the abridged prequalification assessment