Medical devices

Selection, access and use of in vitro diagnostics

Introduction

Access to good quality, affordable, and appropriate health products is indispensable to advance universal health coverage, address health emergencies, and promote healthier populations – the three strategic priorities of the World Health Organization (WHO) Thirteenth General Programme of Work 2019–2023. Without access to In vitro diagnostics (IVDs), health providers cannot diagnose patients effectively and promptly or provide appropriate treatments.


Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD)

The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and strategies related to in vitro diagnostics (IVDs). The SAGE IVD is expected to meet annually to make recommendations on the content, format and implementation of the EDL and on any matters related to IVDs.

The EDL is intended to provide evidence-based guidance and set a reference for the development or update of national lists of essential in vitro diagnostic tests. National essential medicines lists have been successful in raising awareness and political will, guiding procurement and regulation policies and facilitating access to affordable medicines, particularly in low-resourced countries, by prioritizing the most important medicines all countries need to make available to their populations. It is expected that national essential diagnostics lists will provide similar benefits and improve access to essential in vitro diagnostic tests. It will also contribute towards health systems strengthening and realizing universal health coverage, which is central to Goal 3 of the Sustainable Development Goals (Ensure healthy lives and promote well-being for all at all ages).

3rd Meeting of the Strategic Advisory Group of Experts on IVDs will take place at WHO Headquarters, Geneva, on 23-27 March 2020

The Group will revise and update the WHO Model List of Essential In Vitro Diagnostics List (EDL).

2nd Meeting of the Strategic Advisory Group of Experts on IVDs (18-22 March 2019)

1st Meeting of the Strategic Advisory Group of Experts on IVDs (16-20 April 2018)

In order to support the implementation of the WHO Model List of Essential in vitro Diagnostics by Member States, WHO created a web portal for all existing WHO resources on IVDs and laboratory.