- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > post-emergency-use-listing safety monitoring - medicines, IVDs, vaccines granted EUAL
- Keywords > selection process
- Keywords > in vitro Diagnostic (IVD)
- Keywords > in vitro diagnostic medical devices
- Keywords > WHO Model List of Essential In Vitro Diagnostics (EDL)
(2019; 236 pages)
This report presents the deliberations and findings of the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) meeting in March 2019, which was convened to make recommendations on the test categories to be included in the Second WHO Model List of Essential In Vitro Diagnostics (EDL). SAGE IVD is tasked with acting as an advisory body on matters of global policies and strategies related to in vitro diagnostics (IVDs). The report describes the scope and recommended use of the List and details of the methods, the criteria for prioritizing IVDs, and the procedures for establishing the List. It also includes the procedures for updating the List, its integration with other WHO initiatives and its adaption to national contexts. Finally, it contains recommendations from the SAGE IVD on test categories together with a full description of the evidence considered for each test submission, and the voting method for approval or rejection of submissions. In addition, it contains a description of discussions that took place during the open day of the SAGE IVD meeting, which was attended by various stakeholders, including representatives from member state governments, NGO’s, the diagnostics industry, academia, and others.