The role of in vitro diagnostics (IVDs) is particularly important during health emergencies. Successful containment of an outbreak, for example, may be dependent on use of diagnostics from initial detection to eventual resolution But as has been seen during recent public health emergencies, IVDs that have been prequalified by WHO or approved by a stringent regulatory authority may be unavailable.

Similarly, procurers may face a situation whereby they need to procure IVDs to maintain and monitor a public health programme but cannot procure products that have been evaluated and confirmed to be quality-assured. Either no prequalified or stringently-assessed products are available, or some may be available but not in sufficient quantity to meet procurement needs.

In these situations risk–benefit assessment by experts can fill the gap. WHO currently operates two mechanisms that provide this service with respect to IVDs: the Emergency Use Listing Procedure (EUL), and the Expert Review Panel for Diagnostics (ERPD).

WHO developed the EUL process to expedite the availability of unlicensed medical products needed in public health emergency situations, to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products in the context of a public health emergency, based on an essential set of available quality, safety, and efficacy data.

ERPD is a group of independent experts who review the potential risks and benefits associated with the use of IVDs that have not yet undergone stringent assessment. Following its review of products, the group makes recommendations regarding their potential procurement to the procurement agency that requested the assessment.