Classification of Complaints

The risk associated with use of an IVD depends, among other factors, on the intended use setting. In high-resource settings, clinical testing typically takes place in accredited laboratories by certified and proficient users using products that have undergone established pre-market assessment for their appropriateness to be used in that intended setting. However, in many countries, HIV and malaria testing for diagnosis using rapid diagnostic tests is not performed in a traditional laboratory setting and is performed by unsupported users with minimal training. In addition, the risk that an incorrect test result will lead to serious consequences (death or serious deterioration in health) for an individual or the population is greater in settings with higher disease prevalence and lower access to diagnosis, care and treatment services.

The manufacturer of a prequalified IVD is obliged to have undertaken risk management and risk assessment with respect to the IVD before placing it on the market, implementing the most stringent controls
to those aspects of design, and manufacturing and control steps where the risk is greatest. When a complaint is received, the manufacturer should review and update the risk management file for the IVD accordingly. Manufacturers, regulators and procurers will use the information generated by complaints and any other information and experience with a given IVD to determine the scope and stringency of
post-market actions in the future. On the positive side, continued acceptable results in pre-distribution lot verification testing may lead to a change from systematic sampling of each lot towards random sampling of lots.