Rapid advances in development of medical devices are generating challenges in quality assurance for manufacturers and regulators, and in both quality assurance and product selection for procurers. Launched in 2010, WHO prequalification of in vitro diagnostics provides a valuable service to each of these groups.
Procurers can procure prequalified IVDs secure in the knowledge these products are not only quality-assured but also appropriate for their intended setting of use. Manufacturers who attain prequalification of their products will be able to offer those products for supply to procurement agencies and organizations that apply quality assurance policies to all health product procurement. For manufacturers, obtaining prequalification also provides an opportunity to review and even enhance their quality of production. For regulators in low- and middle-income countries — where medical device regulation continues to evolve — IVD prequalification provides complementary and valuable regulatory support. It participates in development of international standards for medicial device regulation, applies these standards during product assessment and works with LMIC regulators to incorporate these standards in their own regulatory activities.
But the most important benefactors of IVD prequalification are health workers and patients, for whom quality-assured IVDs are vital for effective diagnosis, monitoring of therapeutic efficiency and the prevention of the development of drug resistance.
WHO IVD prequalification also undertakes prequalification of male circumcision devices as a contribution to prevention of heterosexually-acquired HIV infection in men.
Key activities and standards
The principal IVD prequalification activities are:
- assessment of product dossiers
- performance evaluation
- inspection of manufacturing sites.
On this website
This IVD part of the WHO prequalification website:
- makes available key prequalification outputs: the lists of prequalified IVDs and MCDs, and WHO Public Assessment Reports and WHO Public Inspection Reports
- provides detailed information about submission of IVDs and MCDs
- describes how laboratories can seek listing as a WHO performance evaluation laboratory
- provides links to considerable prequalification and other WHO guidance: these are relevant not only to manufacturers seeking prequalification but also to all IVD and MCD manufacturers who wish to ensure quality-assured production, and to regulators of medical devices
- provides information about IVD evaluation pathways other than prequalification
- provides an overview of market information that can help manufacturers make decisions regarding submission for prequalification.