Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

products. This

nomenclature Nomenclature (, ) is a system of names or terms, or the rules for forming these terms in a particular field of arts or sciences. The principles of naming vary from the relatively informal naming conventions, conventions of everyday speech to the i ...

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 Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specific ...

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 ISO is the most common abbreviation for the International Organization for Standardization. ISO or Iso may also refer to: Business and finance * Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007 * Iso ...

15225.

Governance

The GMDN meets the need to identify medical devices at the global level, as identified in the

Global Harmonization Task Force The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry”

(GHTF) that have since disbanded (2012) and replaced by the IMDRF GMDN is managed by the GMDN Agency, a

non-profit organization A nonprofit organization (NPO) or non-profit organisation, also known as a non-business entity, not-for-profit organization, or nonprofit institution, is a legal entity organized and operated for a collective, public or social benefit, in co ...

and Registered Charity, which reports to its Board of Trustees, that represent medical device regulators and industry.

Structure

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: * 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 term and other associated data is

copyright A copyright is a type of intellectual property that gives its owner the exclusive right to copy, distribute, adapt, display, and perform a creative work, usually for a limited time. The creative work may be in a literary, artistic, education ...

protected and the GMDN is a

Trademark A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from others ...

. Uniquely each GMDN term has a set of attributes, known as Collective Terms, which help to navigate the GMDN Database and aid the selection of a GMDN term by medical condition or product feature. The GMDN is used by regulators, healthcare providers and others for activities such as medical device recalls, adverse event reporting and postmarket surveillance and monitoring, as well as inventory control and other healthcare management functions. The GMDN Agency updates the GMDN utilizing member change requests, to add a new generic device term or to change an existing Term Name or Definition. The decisions are made by an international expert team, according to ISO 15225. The GMDN Agency releases updates to the GMDN on a daily basis, on their interactive website, the GMDN Database. Only Members have access to the GMDN Database. Since 1 April 2019 GMDN membership and therefore access to GMDN Terms and Codes has been free of any charge. The GMDN is available in English and other languages.

International use

The GMDN is part of the 'minimum data set' of the

US FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

Unique Device Identification The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. It was signed into law in the US on September 27, 2007, as par ...

regulation for the registration of new Medical Devices intended for use in the United States. This follows the international consensus established by the

International Medical Device Regulators Forum International is an adjective (also used as a noun) meaning "between nations". International may also refer to: Music Albums * ''International'' (Kevin Michael album), 2011 * ''International'' (New Order album), 2002 * ''International'' (The T ...

(IMDRF). The GMDN is required by the UK's national medical device regulator, the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

The government agency responsible for medical device safety in Australia

Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pa ...

require the GMDN when registering a product within its ARTG system The GMDN Agency has established long term cooperation with the IHTSDO. The Cooperation Agreement shall result in the use of the GMDN as the medical device component of

SNOMED CT SNOMED CT or SNOMED Clinical Terms is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. SNOMED CT is considered to be the mo ...

. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed: * A more comprehensive and harmonised clinical terminology * Greater utility and access to both terminologies * Opportunities to improve organisational efficiencies The Agreement will benefit patients across the world and all users of

and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases.

References

External links

GMDN Agency
- More information about GMDN {{DEFAULTSORT:Gmdn Medical classification Health standards

Governance

Structure

International use

See also

References

External links