WHO Decides that all Changes to Prequalified IVDs Must be Reported

Manufacturers of prequalified in vitro diagnostics (IVD) are required to submit change reports to the World Health Organization or they risk having their product de-listed from the compendium of prequalified IVDs.

Reportable changes, according to new WHO draft guidance issued late last week, include:

  • Changes to the IVD or how it’s manufactured that have the potential to impact an IVD’s function, performance, usability or safety
  • Changes to a company’s quality management system (QMS), ie., a change in the ISO 13485:2003 certification status
  • And some administrative changes

To read the full article and to access the WHO draft guidance which has been released for public comment, please click here.

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Published on 16. February 2016 in News EU, News France, News UK