Bundibugyo virus disease PHEIC - Emergency Use Listing Procedure (EUL) for IVDs
On 5 May 2026, the World Health Organization (WHO) was alerted of a high-mortality
outbreak of an unknown illness in Ituri Province, Democratic Republic of the Congo,
where several people—including health workers—had died. By 14 May, laboratory
testing conducted by the Institut National de Recherche Biomédicale (INRB) in
Kinshasa confirmed that the illness was Bundibugyo virus disease (BVD), a type of
Ebola. Recognizing the seriousness of the situation and its spread across borders into
Uganda, the WHO Director-General declared the outbreak a Public Health Emergency
of International Concern (PHEIC) on 16 May 2026 (note) . BVD is a severe and often fatal
disease caused by the Bundibugyo virus (BDBV) that can pass from animals to humans
and then spread between people through direct contact with bodily fluids or
contaminated surfaces.
On 29 May 2026, WHO has published the invitation to manufacturers for Expression of Interest and the Instructions and requirements for EUL submissions of IVDs for Bundibugyo virus
(BDBV) nucleic acid detection.
Manufacturers of IVDs Bundibugyo virus (BDBV) nucleic acid detection are encouraged
to complete the product questionnaire and submit it along with a copy of the product
IFU (in English) to diagnostics@who.int. Based on the questionnaire, manufacturers
may be contacted by WHO to arrange a pre-submission call to discuss next steps.
Related Documents:
Information provided here consists of an overview of the evaluation progress of the active applications in the emergency use listing assessment of Bundibugyo virus disease (BDBV). For each product the status for each stage of evaluation is given.
This list does not reflect a decision on EUL assessment and must not be used to inform procurement as it does not constitute an endorsement or WHO listing of the products.