Medical devices

Selection, access and use of in vitro diagnostics

Introduction

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 held its first meeting from 16 – 20 April 2018 at WHO headquarters in Geneva. The objectives of the meeting were to define the methods and the work of SAGE IVD, to make recommendations on the development of a Model List of Essential In Vitro Diagnostics (EDL) and on prioritization for eligibility for WHO Prequalification of in vitro diagnostics.

Like the established Essential Medicines List (EML), 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 the similar benefits and improve access to essential in vitro diagnostic tests. It will also contribute towards health system strengthening and realizing the 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).

The SAGE IVD made recommendations for the content, format and implementation of the first EDL, which are described in the Executive Summary, together with the list of participants, the declaration of interests and the first edition of the list.

The first edition of the WHO Model List of Essential In Vitro Diagnostics (EDL) was launched on the 15 May 2018.