Non-reportable Changes

Minor that do not need to be reported to WHO may include, but are not limited to simple changes to the product labelling documentation, such as:

  • rewording or expanding for clarification
  • translating the label and/or instructions for use (IFU) from one language to another
  • correcting typographical errors
  • replacing (or complementing) written text by internationally recognized symbols
  • minor software changes that do not impact the safety or performance of the product
  • minor QMS changes such as increased post-market surveillance activity or regular updates of controlled QMS procedures (such as control of documents, management review etc.)
  • minor manufacturing changes that would not have an effect on the safety or performance of the prequalified IVD
  • additional in-process quality control criteria or test methods for manufacturing processes to provide equivalent or better assurances of reliability, as determined by the manufacturer but which do not affect safety or performance.

Changes to the WHO key authorized contact for the manufacturer are also not reportable but WHO should be notified of them by email (to and the manufacturer should provide a signed letter from the manufacturer appointing new contacts as authorized to represent the manufacturer for the purposes of prequalification.