Assessment of IVDs

The number of products available for a very broad range of analytes, and the resources available to conduct assessments, mean that using the same approach to assess all IVDs in the pre-market phase is not feasible. WHO therefore uses an internationally harmonized, risk-based approach to assessment, in which IVDs are classified according to the risk they pose to public and individual health, and taking into account the potential outcomes and impact if the test does not perform properly or is not available. The risk class determines the extent of regulatory assessment undertaken and ensures that resources are focused on those IVDs associated with the greatest potential risk.

Assessment of MCDs

Assessment of for WHO prequalification of male circumcision devices (MCDs) focuses on devices intended for use in settings of high HIV incidence and that can potentially contribute to reduced risk of HIV infection in adult male populations.

IVD and MCD assessors

Assessors involved in product dossier review for IVD or MCD prequalification have appropriate qualifications and expertise in the relevant fields and must comply with the confidentiality and conflict of interest rules of WHO. The assessorsact as temporary advisers to WHO.

Assessment of product dossiers is conducted in accordance with standard operating procedures established by WHO for that purpose so as to ensure uniformity in evaluation and timeliness of assessment activities. If needed, WHO may provide training to assessors.