27 June 2025

by Chinaniso Majoni, Senior Nomenclature Developer at the GMDN Agency

During nearly two decades of nomenclature development, the Global Medical Device Nomenclature (GMDN) has transformed from a patchwork of inherited national systems into a harmonised, structured framework supporting device regulation, procurement, and patient safety around the world. As the medical technology landscape has evolved, shaped by innovation, public health challenges, and regulatory reform, so too has the GMDN. This article explores some of the most significant changes made to the nomenclature between 2006 and 2024, and what they reveal about the future of global device classification.

A History of Strategic Refinement

When the GMDN was first developed, it drew terminology from various sources including the FDA, ECRI, EDMA, NKKN and UNSPC. This brought with it a lack of consistency in structure, terminology, and granularity. Beginning in 2006, the GMDN Agency undertook a major refinement effort. Terms were revised from hierarchical, classification-style structures (e.g., “Spatula, surgical, orthopaedic”) to clearer, clinically oriented descriptors such as “Orthopaedic cement spatula.” Functional distinctions also emerged during this period, particularly for powered and implantable devices. Anatomical specificity and power source distinctions became standard, responding to regulatory needs and improving the detail of device definitions.

By 2007 and beyond, material-based differentiation gained importance, particularly in response to emerging safety concerns such as metal-on-metal hip implants and latex allergies. These risks prompted regulators like the FDA to require better labelling, which the GMDN supported through clearer terminology that captured material composition.

Responding to Regulatory and Clinical Demands

As regulatory expectations evolved and clinical risks became more evident, the GMDN adapted to better reflect real-world use and improve patient safety. One early shift was the introduction of anatomical site distinctions, particularly in response to serious safety events. For example, feeding tubes were differentiated by placement site such as nasogastric, jejunostomy or orogastric, following fatal introduction incidents in the UK.

This level of granularity helped to specify these devices as they are associate with different risks at their intended placement site.

Paediatric-specific terminology also emerged in response to growing regulatory recognition that children are not simply small adults. Reflecting differences in anatomy and vulnerability, these terms aligned with legislative developments such as the US Paediatric Medical Device Safety and Improvement Act (2007) and similar provisions in the EU Medical Device Regulation (MDR).

In vitro diagnostic (IVD) devices received focused attention between 2010 and 2011, when the GMDN undertook a major restructuring to distinguish IVD from non-IVD terms. This was driven by the need to align with regulatory frameworks that treat these devices differently and to reduce confusion in classification and risk management. The result was a harmonised set of IVD terms clearly marked with an “IVD” suffix and built around consistent attributes such as analyte, specimen type and technology.

Further impactful refinements were made in response to risks linked to material properties and clinical application. The introduction of ‘bioabsorbable’ distinctions for implants and sutures addressed the need to classify devices based on how they degrade within the body, an important factor in both clinical performance and safety. Similarly, surgical mesh terminology was updated to clearly separate transvaginal mesh for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) from other mesh products, following regulatory restrictions and safety reviews in the United States and the United Kingdom.

Distinctions based on context of use also became a priority. Devices intended for home use or self-testing, such as glucose meters and pregnancy tests, were explicitly identified as separate from their clinical-use counterparts. This differentiation supports regulatory requirements for user-specific safety and labelling considerations.

Even the connectors used between devices underwent redefinition to align with international standards such as ISO 80369. By focusing on the type of connection, for example Luer-to-Luer, rather than the devices being connected, the GMDN improved clarity making it easier to identify these devices.

These a few of the examples underscore the GMDN’s role not just as a regulatory tool, but as a responsive system that evolves alongside emerging evidence, stakeholder feedback and the shifting landscape of clinical care.

Reflecting a More Digital, Connected World

By the mid-2010s, digital health was gaining traction, prompting the GMDN to review its software-related terms. Where once multiple granular software terms existed, such as those for specific X-ray systems, these were consolidated under broader, clinically meaningful categories. This shift recognised that not every software configuration required a distinct generic device name, especially as software becomes more modular and rapidly updated.

The same logic led to the 2021 decision to phase out ‘telemetric’ as a distinguishing attribute. Technologies like Bluetooth and NFC are now standard features in most devices, and international standards such as ISO/IEEE 11073 have made interoperability more routine. GMDN terms have adapted accordingly, simplifying where appropriate and focusing on clinical impact rather than embedded technologies.

The Power of Collaboration

Throughout its development, the GMDN has worked closely with regulators, manufacturers, and other stakeholders, as well as keeping up-to-date with relevant standards to stay aligned with industry needs. The 2018 consultation on removing sterility as a term-level distinction is one example of this collaborative approach. With sterility status now captured in UDI databases, including it in GMDN terminology became redundant. The community backed the change, which has since been fully implemented.

Similarly, reviews of orthopaedic terms in 2023 and earlier revisions of connectors and sutures show how ongoing dialogue between stakeholders can lead to clearer, more efficient device classification.

Preparing for the Future: Challenges and Opportunities

As we move further into the digital age, the GMDN faces new challenges. Artificial intelligence and machine learning-based software do not fit neatly into traditional classification systems. Add to this the global trend towards regulatory fragmentation, where regions develop divergent frameworks, and the role of a unified nomenclature becomes both more important and more complex.

Another ongoing challenge in leveraging GMDN for meaningful regulatory and clinical insights lies in the quality of term assignment within UDI databases. The utility of GMDN as a harmonised tool is fundamentally dependent on the accuracy and consistency with which terms are applied to device records. Misassigned or overly broad terms dilute the granularity and analytical value of the data, especially in large-scale databases such as the FDA’s GUDID. High-quality assignment practices, including the use of up-to-date term definitions and engagement with expert guidance, are essential for ensuring that GMDN can support downstream uses such as post-market surveillance, supply chain analysis, and patient safety monitoring. As the medical device ecosystem becomes more data-driven, accurate mapping of devices to the correct GMDN terms is not just an administrative task; it is a critical enabler of actionable intelligence.

To remain relevant, the GMDN must also balance innovation with clarity. It must continue to evolve it’s offering in line with the MedTech landscape, build interoperability with UDI databases, and resist the temptation to follow regional divergence. Above all, it must maintain its commitment to transparency, stakeholder engagement, and evidence-based decision-making.

Final Thoughts

The GMDN’s journey from 2006 to 2024 is more than just a story of technical refinement. It is a reflection of the changing nature of healthcare, risk, and innovation. By adapting to the evolving medical technology environment while maintaining its global scope, the GMDN continues to provide a foundation for safety, regulation, and effective device use worldwide. Its future success will depend on its ability to stay collaborative, forward-thinking, and focused on the needs of both patients and professionals.