Global Medical Device Nomenclature

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.[1] 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,[2] including the European databank for medical devices (Eudamed).[3]

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.

Governance

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,[4] 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:

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

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 and membership is priced according to organization type and size. The GMDN is available in English and other languages.

International use

The GMDN is used in the European Databank on Medical Devices (Eudamed)[5] 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 US FDA[6] Unique Device Identification regulation for the registration of new Medical Devices intended for use in the United States. This follows the international consensus[7] established by the International Medical Device Regulatory Forum (IMDRF),[8]

The GMDN Agency has recently finalised the business principles that will form the basis of a long term cooperation with the IHTSDO.[9] The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed:

The Agreement will benefit patients across the world and all users of SNOMED CT 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.

See also

  • Medical device
  • Meddra - Terminology for the pharmaceutical industry.
  • IHTSDO - International Health Terminology Standards Development Organisation

References

  1. ↑ ISO 15225:2010 "Medical devices -- Quality management -- Medical device nomenclature data structure" http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50728
  2. ↑ EC Medical Devices regulatory framework http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm
  3. ↑ http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/index_en.htm
  4. ↑ Charitable organization#United Kingdom
  5. ↑ Eudamed http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm
  6. ↑ US FDA Unique Device Identification http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
  7. ↑ http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf
  8. ↑ International Medical Device Regulatory Forum website http://www.imdrf.org
  9. ↑ IHTSDO http://www.ihtsdo.org/

External links

This article is issued from Wikipedia - version of the 11/9/2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.