Training for IVDs assessors for WHO Prequalification WHO Academy Lyon, 7-9 October 2025

A core component of the Prequalification assessment process relates to technical review of the product dossier and change requests. To undertake this activity subject matter experts, with proven technical expertise, conduct a review of information and evidence submitted by the manufacturer in the product dossier or change request to determine whether prequalification requirements are met. A training session was held at the WHO Academy in Lyon from 7-9 October to provide training for subject matter experts on assessment of product dossiers and change request submissions. Through this training opportunity WHO is expanding the group of experts that support prequalification of IVDs. The training session focused on understanding the manufacturer’s claims for the performance of their product and assessment of evidence against the Technical Specification Series (TSS) and PQ dossier requirements. Participants worked on case studies of product dossier and change request submissions to build their skills reviewing technical information and writing assessment reports to ensure they are ready to fully contribute to future PQ assessment of IVDs.