Reportable Changes

All substantial changes are considered as reportable changes. A reportable change is one that is demonstrated, through risk analysis, to have a potential impact on the function, performance, usability, or safety of a prequalified IVD. A reportable change may:

  • introduce new hazards that have not been previously addressed
  • adversely affect risks associated with existing hazards
  • alter the presentation of existing or new risks to the user (this can involve labelling changes or new indications for use).

Reportable changes therefore include:

  • any changes to the prequalified product or its design, labelling or manufacture
  • any changes to the QMS under which the product was designed and manufactured.

In addition, some administrative changes must also be reported.