The process for Term creation, amendments and, in the rarer cases, obsoletion, is triggered primarily by Enquiries submitted by manufacturers, when they cannot readily identify a suitable Term for their device within the existing nomenclature. This is driven largely by innovation, as manufacturers create novel devices, incrementally innovate and expand the intended use profile and clinical applications of their devices. The submission of an Enquiry, which is essentially a request for the GMDN to consider the creation of a new Term, begins a collaborative process between the Nomenclature Development Team and the manufacturer. Since the generic device groups representing and describing these devices must reflect the technology, intended use and clinical application, we rely heavily on the product information submitted by the manufacturer both to understand the device, and how a Term describing that device would sit within the existing nomenclature. The avoidance of overlap between Terms is a fundamental principle of our authoring approach, with an aim to maintain a dataset of mutually exclusive Terms, which underpins the stability and reliability of the nomenclature.

Our authoring process therefore considers all of these factors, and before the creation of a new Term, there is a thorough review of the existing Terms to determine whether an appropriate Term already exists, or whether it would be more appropriate to expand the scope of an existing Term to accommodate a new device. This process involves identifying and evaluating distinguishing device attributes such as intended use, technology, invasiveness, materials (where applicable), clinical application (including anatomical speciality and frequency of use) and context of use. Where appropriate, we also consider the downstream impact of significant changes, particularly as GMDN is more widely adopted across regulatory and procurement processes. It is this careful, considered approach that lends robustness to the nomenclature.

The entirety of this process is captured in a record which documents all aspects of the journey to the draft Term proposed by a Nomenclature Developer. Before publication, each draft Term is quality checked by a Senior Nomenclature Developer for technical correctness, to ensure it follows our authoring guidelines and verify that there will be no unintended overlap should the draft be published. Further checks include consistency reviews, to confirm that the draft Term fits cohesively within the nomenclature and aligns with any related Terms. It is also an opportunity to review the suitability of the Categories allocated to the draft, which is particularly important for users of our Categories, including regulators and manufacturers who use them in registration processes where there may be a cost implication.

The final and perhaps most important quality check is that performed by the manufacturer responsible for the Enquiry submission. We value their input greatly, as they know their device best. Whilst we are experts in the structure and governance of the nomenclature, we recognise and respect that they are the experts in their own technologies. Their feedback is therefore considered carefully, and where necessary, we will revise the draft Term or reconsider our approach entirely.

As with any rigorous development process, there are cases of sufficient complexity, where we seek input from a broader range of stakeholders, including regulators, academia and clinicians. We typically refer such cases to our Technical Advisory Group (TAG) or identify manufacturers from our membership base who are well-placed to assist in a consultation process. This brings an important external perspective and helps to ensure that the decisions we make are firmly rooted in real-world applications and requirements. Not only does this make for a functional nomenclature, but it helps to ensure that it remains relevant and responsive to the needs of our stakeholders.

The Enquiry process concludes with the publication of the new Term, or the amendment of an existing Term. Each new Term is issued with a unique five-digit numerical code and immediately appears on our online platform. It is also added to the daily ‘delta’ file, which captures all new Terms, amendments and obsoletions occurring within the same twenty-four-hour period. At the end of each month, these changes are compiled into the main export file for that period. Both files are shared freely with regulatory bodies, healthcare institutions and government organisations worldwide, via automated transfer (FTP or API) or through a manual download from our platform.

The GMDN Term Development process is, by design, a thorough one. Our Nomenclature Team works within a documented Quality Management System certified to ISO 9001, which sets out the procedures, responsibilities, and quality standards that govern every stage of Term Development. Quality assurance activity is embedded throughout, with new Term proposals and amendments subject to mandatory quality checks by Senior Nomenclature Developers before they are made available to the enquirer for review. The entire process and the Nomenclature Team are subject to both internal quality audits and external third-party audit, with the process kept under continuous review to ensure it remains fit for purpose.

Every step, from the initial review of existing terminology to the manufacturer’s final feedback on a draft Term, exists to protect the accuracy, consistency and reliability of a nomenclature that regulatory authorities, manufacturers and healthcare institutions around the world depend upon. We consider our stakeholders to be key contributors to the technical accuracy and relevance of our nomenclature, and it is for that reason that transparency about how we work is important. We want those who engage with the GMDN to understand not only what we do, but why we do it in the way that we do.

Should you have any questions about the Term development process, or wish to discuss a specific Enquiry, we welcome you to contact us directly.