FAQs and Key Updates on the New Change Request Process for Prequalified and EUL IVDs

This edition features a brief Q&A addressing the most common questions related to the updated Change Request (CR) application process for in vitro diagnostics listed under WHO Prequalification or the EUL. It provides practical guidance on using the new Change application form, understanding what changes are reportable, how risk categorization is determined, when a change may require a new application, the regulatory reliance, and other key updates. This resource is designed to support effective communication and provide practical tools for ensuring compliant submissions under the new guidance.