WHO Announces Submissions Call for WHO Model List of Essential In Vitro Diagnostics

By Amelia Boldrick

The World Health Organization (WHO) announced a call for submissions (March 20, 2024) for its fifth Essential Devices List (EDL); an evidence-based health policy document analogous to the WHO Essential Medicines List.

The WHO is an Official Observer of the International Medical Device Regulators Forum (IMDRF).

Background on the WHO EDL 

Individual countries that operate frameworks of universal health coverage use the EDL to develop their lists of noncommunicable and infectious disease assays. The list improves the availability, access, and proper use of In Vitro diagnostic devices (IVDs).

Governments, United Nations agencies and non-governmental organizations can use the EDL to prioritize the selection, procurement, and supply of IVDs that are essential to safeguard public health at the national level. Private health technology and manufacturing sectors may find the EDL useful in prioritizing the development of these IVDs. The EDL also identifies the devices which are likely to be included in national tenders.

Submissions for The EDL 5

Applicants for new IVDs will be asked to provide background information such as public health impact and prevalence of the disease/condition, potential public health impact of the test, clinical utility of the proposed test, potential impact of the test on patient management and care, and evidence for clinical accuracy, utility, and impact. Applicants are also requested to furnish information on requirements for training, equipment and energy, as well as cost-effectiveness and ethical considerations.

The WHO has outlined 21 “high priority” IVD categories of specific interest, though applications for tests not included within these categories will also be considered.

Stakeholders are invited to contact the EDL Secretariat via email to express their intent to apply before the deadline (June 30, 2024).

Concluding remarks

Emergo has experience sharing our consulting knowledge on IVDs and helping manufacturers navigate the challenges they face from concept to market.