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Changes to Prequalified IVDs

Changes to Prequalified IVDs

New WHO guidance on reportable changes

On 25 September 2026, WHO published the revised guidance Reportable Changes to WHO Prequalified and Emergency Use Listed IVDs and Non-IVD Medical Devices, together with the revised application form. 

The revised guidance reflects feedback received through the 2025 survey of manufacturers of WHO-prequalified IVDs, as well as lessons learned from the implementation of the previous guidance. Following the launch of the WHO prequalification procedure for medical devices, its scope has also been expanded to cover post-prequalification change applications for both IVDs and non-IVD medical devices.

The September 2026 version supersedes the previous version published in March 2025, subject to the following transition arrangements.

Applicability to prequalified and EUL IVDs

A transition period will remain in place until 31 December 2026. During this period, manufacturers may submit an IVD change application using either:

The guidance and application form from the same version must be used together.

From 1 January 2027, all new IVD change applications must follow PQDx_121, September 2026 and use PQDx_119, September 2026.

As part of the life cycle of an IVD, changes to the product, its components, its manufacture (e.g. processes, or manufacturing location), and/or the QMS under which it is produced, may become necessary. 

Changes to products that have been WHO Prequalified or listed under the WHO Emergency Use Listing (EUL) Procedure require prior approval when they may significantly affect the quality, safety and/or performance of the product. 

This WHO guidance document outlines the process and provides instructions for manufacturers of IVDs 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 kinds of changes to an IVD require prior approval before they can be implemented. Any of the changes that have the potential to significantly affect the quality, safety, or performance of the product or necessitate an update of the WHO public report information are considered as “reportable changes”. 

The guidance not only defines what counts as a reportable change but also explains how to assess the potential impact of these changes. Depending on the outcome of the categorization, manufacturers must submit specific documents to support the change request application. Compliance with these requirements is necessary for manufacturers seeking to maintain the prequalified or EUL status of their IVDs. 

In line WHO’s commitment to supporting manufacturers in their efforts to maintain high-quality, safe, and effective diagnostic products a frequently asked questions supplement is available here Q & A Change Request for WHO Prequalified and Emergency Use Listed in vitro and a Position Note on Accessories, to be used in conjunction with the guidance document. 

Reportable change assessment timelines

The indicative timeliness of WHO's assessment of reportable changes are outlined below:

 

 

Stage of Post PQ reportable Change assessment

Maximum time allowed (calendar days) to provide a response

___________________________________________________

                     WHO                               Manufacturer

  1. Change request screening (S1)

30 days

 

  1. Submission of additional information (if applicable)

 

30 days

  1. Screening of additional information (S2) (if applicable)

30 days

 

  1. Assessment (R1 review) of the initial submission of Reportable change 

60 days

 

 

If additional information is found necessary 

Maximum time allowed (calendar days) to provide a response

___________________________________________________

                     WHO                             Manufacturer

  1. Submission of response to R1 review with additional information (if applicable)

 

30 days

  1. R2 review of additional information (if applicable) 

60 days

 

  1. Submission of final response to R2 review with additional information (if applicable)

 

30 days

  1. R3 review of additional information (if applicable)

60 days

 

Change request assessment fee

The cost of the activities required to assess a change will be covered in part by the manufacturer. A non-refundable change request fee of US$ 3000 will contribute to the costs associated with change documentation review and dissemination of change information. The assessment of the change will commence upon fee payment. The guidance document “WHO’s Prequalification fees” provides full information on the fees levied.