Emergency Use Assessment and Listing (EUAL) Procedure for IVDs
The WHO Emergency Use Assessment and Listing (EUAL) procedure was set up as an extraordinary process intended to provide guidance to interested UN procurement agencies and National Regulatory Authorities (NRAs) of WHO Member States on the quality, safety and performance of certain In Vitro Diagnostics (IVDs). WHO may elect to open the EUAL procedure to IVDs required for the diagnosis and surveillance of any disease that has been declared a Public Health Emergency of International Concern (PHEIC).
The WHO Emergency Use Assessment and Listing (EUAL) procedure has three key components:
1. Review of technical documentation relating to safety and performance (e.g. analytical and clinical evidence, stability data); and
2. Review of the documentation relating to the manufacture of the product and the manufacturer’s quality management system (QMS);
3. An independent laboratory evaluation coordinated by WHO of the product’s performance and operational characteristics.
The results of the WHO review of the documentation submitted through the EUAL procedure including quality, safety and performance documentation, and the independent laboratory evaluation are used by WHO to make a decision on the product’s suitability for WHO procurement. Products that are reviewed favourably are then listed as eligible for WHO procurement.