Our History
Experts in medical devices from around the world (Manufacturers, Healthcare Authorities and Regulators) compiled the GMDN based on international standards.
The work was mandated by the European Commission to support the implementation of the first European Medical Device Safety Directives. Since that time the use of the GMDN has spread globally.
The History of GMDN:
The first international workshop on harmonisation of medical devices nomenclature was held. Initial work was started by the European Standards Organisations, CEN.
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 first UDI Database.
The GMDN Agency became a registered UK Charity.
The GMDN Agency moves to purpose-built offices in Oxford, UK.
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 WHO and European Commission.
The GMDN Agency launched a five-year strategy that sets out ambitious visions for growth. The new GMDN brand has been launched. The GMDN Agency establishes the Authorities Strategic Advisory Group (ASAG) which represents medical device Regulators that use the GMDN to provide advice and feedback to Trustees and the GMDN Agency.
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 World Health Organization (WHO) and the GMDN Agency announced a collaboration that will improve the management and safety of medical devices used around the world. The landmark new relationship sees the WHO using 3,000 GMDN Terms, Codes and Definitions within its online medical device information platforms such as the MeDevIS (Priority Medical Devices Information System), an open access WHO electronic database of Medical Devices.