GMDN
Encyclopedia
GMDN or Global Medical Device Nomenclature 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 / regulators, health care providers, medical device manufactures and suppliers, conformity assessment
bodies and others with a single generic naming system that will support patient safety.
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 in the Global Harmonization Task Force
(GHTF) and its founder members, USA (Food and Drug Administration
), Canada (Health Canada
), EU (European Commission
), Japan (Ministry of Health, Labour and Welfare
), Australia (Therapeutic Goods Administration
) and now by many other countries and regions.
GMDN is managed by the GMDN Agency, a non-profit organization
, which reports to its Board of Trustees, that represent medical device regulators and industry.
The GMDN Agency updates the GMDN utilizing member change requests, to add a new device term in the GMDN or to change an existing code. The decisions are made by an international expert team on how the new term is to be described, according to ISO 15225. The GMDN Agency releases updated GMDN terms on a daily basis, on their interactive website, the GMDN Database. The GMDN Database is priced according to organization size. The GMDN is available in English and other languages are being developed.
The codes for each device are known as a Preferred Terms (P). Uniquely, the GMDN uses Collective Terms (CT) to help users identify the correct P Term, by a defined medical condition or area of interest.
Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined Preferred Term, with which all specific devices having substantially similar generic features, can be identified by type. This is important for reasons of data exchange between healthcare authorities, manufacturers and others, exchange of post-market vigilance information, inventory control and purchasing.
The GMDN is used in the European Databank on Medical Devices - EUDAMED which has been established by the European Commission to strengthen market surveillance and vigilance.
The GMDN has been identified as part of the 'minimum data set' for the proposed U.S. FDA Unique Device Identification
for Medical Devices used in the United States.
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
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 / regulators, health care providers, medical device manufactures and suppliers, conformity assessment
Conformity assessment
Conformity assessment, also known as compliance assessment , , , is any activity to determine, directly or indirectly, that a process, product, or service meets relevant technical standards and fulfills relevant requirements....
bodies and others with a single generic naming system that will support patient safety.
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
Medical Devices Directive
The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
, including the European databank for medical devices (Eudamed).
The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force
Global Harmonization Task Force
The Global Harmonization Task Force is “a voluntary group of representatives from national medical device regulatory authorities and the members of the medical device industry” whose goal is the standardization of medical device regulation across the world...
(GHTF) and its founder members, USA (Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
), Canada (Health Canada
Health Canada
Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...
), EU (European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
), Japan (Ministry of Health, Labour and Welfare
Ministry of Health, Labour and Welfare (Japan)
The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
), Australia (Therapeutic Goods Administration
Therapeutic Goods Administration
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
) and now by many other countries and regions.
GMDN is managed by the GMDN Agency, a non-profit organization
Non-profit organization
Nonprofit organization is neither a legal nor technical definition but generally refers to an organization that uses surplus revenues to achieve its goals, rather than distributing them as profit or dividends...
, which reports to its Board of Trustees, that represent medical device regulators and industry.
The GMDN Agency updates the GMDN utilizing member change requests, to add a new device term in the GMDN or to change an existing code. The decisions are made by an international expert team on how the new term is to be described, according to ISO 15225. The GMDN Agency releases updated GMDN terms on a daily basis, on their interactive website, the GMDN Database. The GMDN Database is priced according to organization size. The GMDN is available in English and other languages are being developed.
The codes for each device are known as a Preferred Terms (P). Uniquely, the GMDN uses Collective Terms (CT) to help users identify the correct P Term, by a defined medical condition or area of interest.
Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined Preferred Term, with which all specific devices having substantially similar generic features, can be identified by type. This is important for reasons of data exchange between healthcare authorities, manufacturers and others, exchange of post-market vigilance information, inventory control and purchasing.
The GMDN is used in the European Databank on Medical Devices - EUDAMED which has been established by the European Commission to strengthen market surveillance and vigilance.
The GMDN has been identified as part of the 'minimum data set' for the proposed U.S. FDA Unique Device Identification
Unique Device Identification
The Unique Device Identification System is intended to assign a unique identifier to medical devices within the United States. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related to the establishment...
for Medical Devices used in the United States.
See also
- Medical deviceMedical deviceA medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
- Global Harmonization Task ForceGlobal Harmonization Task ForceThe Global Harmonization Task Force is “a voluntary group of representatives from national medical device regulatory authorities and the members of the medical device industry” whose goal is the standardization of medical device regulation across the world...
- International group tasked with harmonising medical device regulation. - MeddraMedDRAMedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data...
- Terminology for the pharmaceutical industry.
External links
- GMDN Agency - More information about GMDN