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Reportable changes, according to new WHO draft guidance issued late last week, include: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