WHO guidance on reportable changes

Following the launch of the WHO prequalification procedure for medical devices, WHO has published the guidance PQDx_121 Reportable Changes to WHO Prequalified and Emergency Use Listed IVDs and Non -IVD Medical Devices, together with the revised application form PQDx_119 Change Request Form for WHO Prequalified and Emergency Use Listed IVDs and Non-IVD Medical Devices (September 2026).  

Applicability to prequalified non-IVD medical devices

The September 2026 guidance and application form apply to all change applications for prequalified non-IVD medical devices submitted from 25 September 2026. 

As part of the life cycle of a medical device (MD), changes to the product, its components, its manufacture (e.g. processes or manufacturing location), and/or the quality management system (QMS) under which it is produced may become necessary.
Changes to medical devices that have been WHO Prequalified or listed under the WHO Emergency Use Listing (EUL) Procedure require prior approval, as some changes may significantly affect the quality, safety, and/or effectiveness of the device.

This guidance document outlines the process and provides instructions for manufacturers on how to report changes to products that are either WHO prequalified or listed under the EUL Procedure. Its primary purpose is to clarify which types of changes to a medical device require prior approval before implementation. Changes classified as "reportable changes" have the potential to significantly affect the quality, safety, or effectiveness of the device or may necessitate an update to WHO public report information.

The guidance not only defines what constitutes a reportable change but also explains how to assess the potential impact of such changes. Depending on the outcome of the categorization, manufacturers are required to submit specific documentation to support the change request application. Compliance with these requirements is necessary for manufacturers seeking to maintain the prequalified or EUL status of their medical devices.

Guidance Documents: 

• PQDx_121 Reportable Changes to WHO Prequalified and Emergency Use Listed IVDs and Non-IVD Medical Devices
• PQDx_119 Change Request Form for WHO Prequalified and Emergency Use Listed IVDs and Non-IVD Medical Devices