Open from 2 May to 23 May 2025
WHO cordially invites stakeholders to participate in this important consultation on the definition of the term “diagnostics.”
This public consultation seeks to gather input from experts and stakeholders on the term “Diagnostics,” which currently has no official definition within WHO. While related definitions exist in WHO publications and other international references, none comprehensively encompass all types of diagnostics. Your feedback will contribute to the development of a clear, inclusive definition that supports effective global health policies.
Background
The 76th World Health Assembly on 30 May 2023, approved the WHA76.5 resolution named “Strengthening diagnostics capacity.”
The resolution included a footnote 1:
“For the purpose of this resolution, the term “diagnostics” includes medical devices used for the diagnosis, screening, monitoring, prediction, staging or surveillance of diseases or health conditions, both in vitro and non-in vitro types.”
The same resolution requests the WHO secretariat to “to develop and/or update WHO definitions of diagnostics, through a group of experts and public consultations”.
The proposed definition for the consultation
Please submit your comments using this template and send them to diagnostics-taskforce@who.int by 23 May 2025.
Related definitions published by International Medical Device Regulators Forum (IMDRF1): Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) published 26 April 2024.
Medical device: any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury;
- investigation, replacement, modification or support of the anatomy or physiological process;
- supporting or sustaining life;
- control of conception;
- cleaning, disinfection or sterilization of medical devices;
- providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
NOTE 1: Products which may be considered to be medical devices in some jurisdictions but not in others include:
- disinfection substances,
- aids for persons with disabilities,
- devices incorporating animal and/or human tissues,
- devices for in-vitro fertilization or assisted reproduction technologies.
In vitro diagnostic medical device (IVD): a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
NOTE 1: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.
1Acknowledgement: Used with the permission of the International Medical Device Regulators Forum. The International Medical Device Regulators Forum is not responsible for the content or accuracy of this document.