On 30 January 2020, the Director-General declared that the outbreak of COVID-19 caused by SARS-CoV2 constitutes a Public Health Emergency of International Concern (PHEIC) and on 11 March 2020 it was characterized as a pandemic. In vitro diagnostics (IVDs) of assured quality, safety and performance are a critical component of an overall strategy to control the pandemic.

COVID-19 no longer constitutes a public health emergency of international concern (PHEIC) therefore, WHO is no longer accepting any new applications (or resubmissions) under the EUL procedure.

Transition from EUL to WHO Prequalification

WHO has implemented a structured transition from the emergency EUL mechanism to the standard WHO Prequalification (PQ) assessment to ensure continuity of access to quality-assured diagnostics beyond the emergency phase. Products previously listed       under EUL were required to transition to PQ in line with defined timelines and requirements.

Two SARS-CoV-2 antigen detection tests have successfully transitioned from WHO’s Emergency Use Listing (EUL) to full WHO

Prequalification, marking the shift from emergency response mechanisms to long-term quality assurance.

For the full list of WHO-prequalified in vitro diagnostic products, please click here.