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Changes to Prequalified IVDs

Changes to Prequalified IVDs

As part of the life cycle of an IVD, changes to the product, its components, its manufacture (e.g. processes, location), and/or to 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, as some changes can significantly affect the quality, safety and/or performance of the product. 

This WHO guidance document Reportable changes to WHO prequalified and emergency use listed in vitro diagnostics 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 core purpose is to clarify which kinds of changes to an IVD require prior approval before they can be implemented. Any of the changes considered as “reportable changes”, have the potential to significantly affect the quality, safety, or performance of the product or necessitate an update of the WHO public report information. 

The guidance not only defines what counts as a reportable change but also explains how to evaluate the potential impact of these changes. Depending on the outcome of the categorization, manufacturers must submit specific documents to support the change request application. Full compliance with this framework is mandatory for manufacturers seeking to maintain the prequalified or EUL status of their IVDs, ensuring continued trust in the product’s reliability and safety.

In line with 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, 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.