Our History
The History of GMDN:
The Global Medical Device Nomenclature (GMDN) is the world’s foremost standard for naming, defining, and categorising medical devices.
Established in 1991, the first international workshop on medical device nomenclatures was held to create the GMDN. Initially started by the European Standards Organisations (CEN) and later supported by the Global Harmonisation Task Force (now the International Medical Device Regulators Forum – IMDRF) to help accelerate the harmonisation of medical device regulation globally. The GMDN is recommended by the IMDRF and is now used by circa 107 national medical device regulators across the globe.
The system provides a global common language that enables regulators, manufacturers, healthcare providers, and other stakeholders to communicate clearly and consistently about medical devices.
GMDN uses internationally agreed generic descriptors to identify medical devices by intended use, technology/material, form/components, and significant attributes. The GMDN Database is continuously updated with new Terms to capture innovative technologies.
The first international workshop on standardising medical device nomenclature was organised by the European Standards Organisation (CEN) and later supported by the IMDRF.
ISO started work on a global standard nomenclature for medical devices. A project was agreed to be financed by the European Commission.
A project council was established to create the GMDN dataset, based on the international standard: ‘ISO 15225, Nomenclature, specification for a nomenclature system for medical devices for the purpose of regulatory data exchange.’
The GMDN Maintenance Agency Policy Group was established to be responsible for the publication and maintenance of the GMDN.
The first electronic issue of the GMDN is published on CD-ROM.
The GMDN Agency is established as a non-profit company to manage the GMDN and the GMDN website is launched for more convenient online access.
Translations of the GMDN into multiple languages starts.
The GMDN Agency establishes a Board of Trustees and Policy Advisory Group to manage GMDN governance.
Agreement with IHTSDO to use the GMDN within Snomed patient records.
Agreement with US FDA to use the GMDN in the worlds first UDI Database. The GMDN Agency also became a registered UK charity in 2013.
A new website was launched for an improved customer experience, including removing fees for the new terms enquiry service.
Free access to all GMDN Terms was made available following a request from the World Health Organization (WHO) and European Commission.
The GMDN Agency revised the 2022 Strategy in consideration of multi stakeholder interviews and surveys. The Agency launched a new “Category Versioning Service” to enable long-term data analysis. They also established a Technical Advisory Group to replace the Policy Advisory Group.
The WHO and the GMDN Agency announced a landmark collaboration to enhance the management and safety of medical devices worldwide. Under the agreement, the WHO will incorporate 3,000 GMDN Terms, Codes and Definitions into its medical device information platforms, including MeDevIS, its open-access medical device database.