Prequalification of in vitro diagnostics (IVDs) was launched in 2010 in response to the rapidly changing diagnostics landscape and the challenges this represented for procurers. Before 2010, a simpler product evaluation procedure had been used.

IVD prequalification also carries out prequalification of male circumcision devices (MCDs) since these are an important component of HIV prevention in some settings.

The WHO List of Prequalified In Vitro Diagnostic Products and the WHO List of Prequalified Male Circumcision Devices are important sources of procurement information for UN agencies and international and national procurers. 

When purchasing products from either of these lists, the procurement agency should ensure that:

• the most current edition of the list is used
• the contracted manufacturer will supply the product as prequalified and as detailed in the WHO Public Report (including product code, regulatory version)
• the product supplied by the manufacturer was manufactured at the site as listed in the product dossier assessed by WHO and inspected by WHO (and as appears on the list).

WHO negotiates with suppliers of WHO-prequalified products, for WHO-specific terms and conditions. This includes, for example, price per unit (UoM), for example, price per test for single use IVDs, and price for instruments that are necessary to run some prequalified IVDs. WHO conducts a joint tender with other United Nations agencies (UNICEF, UNDP, UNFPA), issuing invitations to bid or requests for proposals for all items listed in the WHO Public Report. However, WHO is unable to make any volume guarantees or country-specific forecasts of need or demand. Member States may use these long-term agreements (LTAs) and procure through WHO offices via the WHO e-catalogues.

Member States may also enter directly into a procurement contract (such as ad-hoc purchase order, or an LTA), with the supplier of a WHO prequalified product who may or may not be the legal manufacturer. The responsibilities of each party should be defined clearly in the agreement, which should make provision for liability and remedies in case of breach of contract. WHO also recommends that procurement agencies perform other aspects of qualification before purchasing products, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.

WHO recommends that procurement agencies enter into an agreement or contract with the manufacturer before purchasing any products. The responsibilities of each party should be defined clearly in the agreement. The agreement should make provision for liability and remedies in case of breach of contract. WHO also recommends that procurement agencies perform other aspects of qualification before purchasing products, such as the ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.

Additional prequalification outputs of value to procurement agencies

Other WHO prequalification outputs are also of value to procurers:

• IVDs Under Assessment and MCDs Under Assessment ― summarizes what products are currently under assessment
• IVDs Eligible for Prequalification and MCDs Eligible for Prequalification ― information on the categories of IVDs and MCDs currently eligible for evaluation for prequalification
• Procedures and Fees for IVD Prequalification and Procedures and Fees for MCD Prequalification ― information on prequalification requirements for IVDs and MCDs
• Post-prequalification Procedures for IVDs and Post-prequalification Procedures for MCDs ― information on what an applicant must do to maintain prequalification status
• Prequalification Reports ― WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites that have passed WHO inspection
• Collaborative Procedure for Accelerated Registration ― describing a WHO procedure that offers manufacturers the opportunity to get their products onto markets more quickly
• Market Information ― with links to reports and sources that contain information (including prices and volume) about who is procuring what
• Risk–benefit Assessment ― describing procedures other than prequalification for assessing products and that may facilitate market entry for manufacturers
• Key Contacts ― the key persons to contact regarding different aspects of prequalification, or collaborative registration or technical assistance.