GMDN

Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

The main purpose of the GMDN is to provide health authorities / regulators, health care providers, conformity assessment bodies and others with a single generic naming system.

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).

In the draft of the proposed Medical Device Regulation (from the European Commission) it states “To facilitate the functioning of the European Databank on medical devices (Eudamed), a medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons obliged to use that nomenclature under this Regulation. Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders.”

GMDN is not a requirement of the current European system, for manufacturers of medical devices who have their own UDIs (unique device identifiers) and traceability.

The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF) that have since disbanded (2012)

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

The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. The following is an example:

The GMDN term and other associated data is copyright protected and the GMDN is a Trademark.

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