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Global Medical Device Nomenclature

"The Global Medical Device Nomenclature (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."

URI http://bartoc.org/en/node/1236
Titles
  • Global Medical Device Nomenclature
  • GMDN
Homepage https://www.gmdnagency.org/
Identifiers
  • http://www.wikidata.org/entity/Q5570492
Languages
  • en
Subject
Access
Format
KOS Type
Address
  • Milton Park
  • Oxford
  • OX14 4RS
  • United Kingdom