GMDN

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:

1991
First international workshop

The first international workshop on harmonisation of medical devices nomenclature was held. Initial work was started by the European Standards Organisations, CEN.

1996
Work on a global standard nomenclature
ISO started work on a global standard nomenclature for medical devices. A project was agreed to be financed by the European Commission.
1997
Creation of the GMDN dataset
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.’
2001
Agency Policy Group established
The GMDN Maintenance Agency Policy Group was established to be responsible for the publication and maintenance of the GMDN.
2002
GMDN is published on CD-ROM
The first electronic issue of the GMDN is published on CD-ROM.
2005
GMDN Agency established as a non-profit company

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.

2008
Language translation
Translations of the GMDN into multiple languages starts.
2009
Formation of Board of Trustees

The GMDN Agency establishes a Board of Trustees and Policy Advisory Group to manage GMDN governance.

 

 

2012
IHTSDO agreement
Agreement with IHTSDO to use the GMDN within Snomed patient records.
2013
US FDA agreement
Agreement with US FDA to use the GMDN in the first UDI Database.
2013
UK Charity
The GMDN Agency became a registered UK Charity.
2014
Oxford offices
The GMDN Agency moves to purpose-built offices in Oxford, UK.
2016
Website launch

A new website was launched for an improved customer experience, including removing fees for the new terms enquiry service.

2019
Free access

Free access to all GMDN Terms was made available following a request from the WHO and European Commission.

2022
Five-year strategy

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. 

2023
Launch of Category Versioning Service

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.