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