Benefits of WHO Prequalification of IVDs and MCDs

WHO in vitro diagnostics (IVDs) prequalification primarily benefits underserved populations in low- and middle-income countries — that have little or no domestic regulatory frameworks for IVDs — and whose need for diagnosis, initiation and monitoring of treatment for high-burden diseases is considerable.

It also supports procurers, regulators, laboratories, manufacturers and donors, in reaching national and international public health objectives.

IVD prequalification:

  • improves public health outcomes and value for money through quality assurance of IVDs which are effective in identifying specific conditions, monitoring therapeutic efficacy, and preventing or slowing development of drug resistance
  • promotes greater public health equity through its focus on IVDs for use in resource-limited settings, in collaboration with relevant WHO technical units
  • improves capacity to manufacture IVDs to international standards by providing effective feedback and guidance during prequalification assessment; best practices learned within a manufacturing company are often shared and replicated for other products
  • generates and makes publicly available independent technical information on the safety, quality and performance of IVDs thereby increasing understanding among manufacturers, regulators and procurers of the requirements to be met to produce and select quality-assured IVDs
  • enhances the capacity of performance evaluation laboratories to meet international standards for testing of specified IVDs through its laboratory audit and listing process; listed laboratories not only contribute to WHO's aim to increase access to quality-assured IVDs but also offer manufacturers the opportunity to manage themselves the performance evaluation of any products they submit for prequalification.

IVD prequalification is also working to accelerate registration of quality-assured IVDs. It is participating in WHO's development of a mechanism to reduce registration time for prequalified IVDs and leads the technical work that supports this mechanism.

Importantly, IVD prequalification also undertakes prequalification of male circumcision devices to accelerate delivery of male circumcision programmes in settings where HIV incidence is high, and helping to reduce risk of HIV infection in adult male populations.