White paper – Global Medical Device Nomenclature (GMDN): A valuable tool for the development of National Essential Diagnostics Lists (NEDLs)

By Chinaniso Majoni, Senior Nomenclature Developer and Quality Lead at the GMDN Agency

25 March 2025

In vitro diagnostic (IVD) medical devices are an integral part of any well-functioning healthcare system. They guide clinical decision-making, shape public health policies, and ensure timely treatment and interventions. Accurately identifying essential diagnostics is crucial for streamlining procurement, improving patient access, and strengthening healthcare systems. However, despite the clear benefits of standardised medical device classification, many countries still struggle with fragmented, inconsistent nomenclature. This inconsistency leads to procurement inefficiencies, regulatory delays, and ultimately, inequitable access to diagnostics.

We propose the Global Medical Device Nomenclature (GMDN)—a standardised naming and classification system that ensures consistency, clarity, and efficiency in medical device categorisation as a key element in the successful implementation of NEDLs. To support this effort, the World Health Organisation (WHO), in collaboration with the GMDN Agency, has made available a tool comprising its Model Essential Diagnostics List (EDL) and the corresponding GMDN Terms and Categories, accessible at: https://edl.who-healthtechnologies.org/nomenclatures.

One of the primary challenges in medical device management is inconsistent terminology. Different countries and organisations often use varied names for the same device, leading to confusion in procurement, regulation, and clinical use. The GMDN provides a globally accepted nomenclature for medical devices, including in vitro diagnostics (IVDs). It’s clear and concise definitions reduce ambiguity in device descriptions, making it easier for governments and health organisations to procure the correct diagnostics. By incorporating GMDN into procurement processes, healthcare providers and agencies can effectively communicate their requirements to manufacturers and identify suitable devices, preventing discrepancies and ensuring timely patient access to essential diagnostics.

Beyond procurement, integrating GMDN into NEDLs improves logistics and supply chain efficiency. By enabling a standardised reference system, it can facilitate accurate forecasting of diagnostic needs, reducing wastage and ensuring availability at various levels of the healthcare system. This is particularly valuable in resource-limited settings where efficient allocation of diagnostics is critical.

While GMDN is a global system, it allows countries to build upon WHO’s Model EDL and customise their NEDLs by adding or removing device groups relevant to their specific contexts. This approach maintains interoperability across jurisdictions, which is particularly valuable in cross-border health crises requiring international cooperation. The widespread adoption of GMDN by major regulatory bodies, including the US FDA, MHRA (UK), ANVISA (Brazil), and Health Canada, reinforces its role in pre- and post-market regulation. This is particularly beneficial for countries that follow a reliance or mutual recognition model. When NEDLs integrate GMDN codes, they align with these regulatory frameworks, streamlining approval and market surveillance processes. This facilitates faster regulatory approvals, efficient safety tracking, and seamless integration with Unique Device Identification (UDI) systems, ensuring traceability within supply chains. Additionally, it enhances post-market surveillance by enabling efficient tracking of device performance and recall management, improving patient safety. The structured categorisation of medical devices under GMDN also supports digital health initiatives, such as national health information systems, ensuring seamless integration of diagnostic data into broader healthcare infrastructures.

The COVID-19 pandemic underscored the critical need for rapid deployment of effective and accurate diagnostics, and the adoption of GMDN in NEDLs is more than a technical necessity; it is a strategic enabler of efficient, transparent, and responsive healthcare systems. Therefore, the Agency will continue to support ongoing efforts to keep the WHO’s Model EDL updated with the relevant GMDN data to ensure continued incorporation of emerging technologies and responsiveness to evolving public health needs and pandemic preparedness efforts. As more countries refine their NEDLs, leveraging GMDN will be instrumental in advancing equitable access to high-quality diagnostics, ultimately strengthening global healthcare systems.