THE GLOBAL MEDICAL DEVICE NOMENCLATURE (GMDN)

The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices. 

It is used by regulators, hospitals and manufacturers to identify medical devices that are of the same generic type.

This supports market surveillance, adverse event reporting, product recall and other healthcare management activities.

The GMDN is a system of internationally agreed generic descriptors used to identify all medical device products.

Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

The main purpose of the GMDN is to provide health authorities and regulators, health care providers, medical device manufacturers and suppliers, conformity assessment bodies and others with a single generic naming system that will support patient safety.

The GMDN is used for:

• Data exchange between manufacturers, regulators and healthcare authorities;
• Exchange of post-market vigilance information;
• Supporting inventory control in hospitals;
• Purchasing and supply chain management.

Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225.

The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive, including the European databank for medical devices, Eudamed.

The GMDN meets the need to identify medical devices at the global level, as identified by the Global Harmonization Task Force (GHTF) and is now used by over 50 national medical device regulators.

The GMDN is managed by the GMDN Agency, a non-profit organization, which reports to its Board of Trustees, that represents medical device regulators and industry.

The GMDN Agency updates the GMDN utilizing member change requests, to add a new device terms to the GMDN.

The decisions are made by an international expert team on how the new term is to be described, according to ISO 15225. 

The GMDN is available in English and 24 other languages.

The GMDN Agency releases new and updated GMDN terms on a daily basis, on their interactive website, the GMDN Database. 

Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined descriptive Preferred Term, with which all specific devices have substantially similar generic features.

All GMDN terms have the following data elements, as seen in this example:

Example of GMDN Code and terms: 

GMDN^® Term Name 

Scalpel, single-use

GMDN^® Code 

47569

GMDN^® Definition 

A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue.

The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic.

This is a single-use device.

The GMDN Database is priced according to organization size.

Users can register for access, apply for new terms and pay on-line.

 About GMDN Membership

The GMDN Agency is responsible for maintaining the GMDN. Access is only available to Members and membership is priced according to organisation type and size. The membership process is completed online and access to the database is immediate upon completion of payment which can be done on-line or by invoice. 

Members search the online database for the GMDN Term that describes their product. Each GMDN Term has a 5-digit Code that is revealed using a code credit. The GMDN Code can then be given to a regulator or customer for their intended use. 

To ensure there is a GMDN Term for all medical devices, for example to meet the need for product innovation, the database is updated using change requests from Members.

For more information visit:

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Welcome to the GMDN

The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices. 

It is used by regulators, hospitals and manufacturers to identify medical devices that are of the same generic type. This supports market surveillance, adverse event reporting, product recall and other healthcare management activities.

EXPLAINER VIDEO