GMDN Agency

The need for a Maintenance Agency was identified and the structure approved within CEN.

Therefore, in order to manage the GMDN, a maintenance agency has been set up to form the necessary legal entity. This non-profit company, “GMDN Agency”, acting as the Maintenance Agency Secretariat (MAS), functions as the hub in the running and maintenance of the GMDN, providing services and information for access to the GMDN data through this present Internet site or other means. To ensure continuing permanency of the GMDN, revenues may be generated through the licensing or sale of GMDN Agency products and services, or by direct funding allocated by relevant global regulatory bodies or other parties.

Services provided by the GMDN Agency are:

• Access to the GMDN data file and codes using this Internet site through a licence agreement and/or by direct credit card purchase.
• A link from the GMDN database to the user’s in-house data system through a licence agreement and a purpose made software link.
• Application form for new terms or modification of existing terms/definitions for the identification of the user’s product.
• Access to GMDN terminology and information.
• Guidance on how to use the GMDN.
• Access to Collective terms.
• GMDN translation software tool.

For services and queries please contact us.

A Maintenance Agency Policy Group (MAPG), now an entity of the GMDN Agency, ensures a globally recognized representation and consists of delegates from authorities and industry, as well as other interested parties. Based on the original Technical Report a vastly developed and enhanced GMDN is now available through the GMDN Agency.

GMDN Origin

Medical Device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the initial GMDN nomenclature based on the standard ISO 15225. The work was mandated by the European Commission in order to provide the necessary tool to carry out many of the obligations following the implementation of the Medical Devices Directives. Also, to meet similar needs at the Global level as identified in the Global harmonization activities of GHTF by its members, notably USA (FDA), Canada, European member states, Japan, Australia and now by many other countries/regions.

This included some 4 years of international consultation and discussion culminating in the Technical Report, which was created within the framework of CEN and ISO.

Activities leading to the CEN Report CR 14230

• 1991 – First international workshop on harmonisation of Medical Devices Nomenclature between EU, EFTA, Canada, and USA. Due to lack of an agreed outcome the Commission - DG III let some time pass before it approached CEN and mandated the standards work.
• 1993 – CEN’s BTS 3 (now CheF Health care Forum) established CEN TC/257/SC 1 as requested by the Commission to prepare a standard to define a structural basis for a medical device nomenclature.
• 1994 – An inaugural meeting of CEN TC/257/SC 1 was convened.
• 1994 – An inaugural meeting of ISO/TC 210 in Arlington, USA established Work Groups on Medical Device issues including ISO/TC 210/WG 3 Symbols, Coding and Nomenclature.
• 1994 – Inaugural meeting of ISO/TC 210/WG 3 in Brussels. Proactive members of CEN TC/257/SC 1/WG 3 were present to demonstrate the European nomenclature structure being developed.
• 1995 – CEN recommendation for an Interim Nomenclature System and rules for a future nomenclature system pending the development of the new European nomenclature.
• 1996 – A Project Proposal for a Device Nomenclature system was submitted to the Commission.
• 1996 – BTS 3 resolution 31/1996 – Recommendations for an Interim System and for a Future System.
• 1996 – BTS resolution 32/1996 to approve the setting up of a European managed Nomenclature project.
• 1996 – Acceptance by IOS/TC 210/WG 3 of the European Nomenclature Standard (now ISO EN 15225) through the Vienna Agreement. This resulted in one single harmonized standard.
• 1996 – Final acceptance of a Project Proposal by the Commission for a project to be financed by the Commission to produce the first global nomenclature.
• 1996 – License agreement between ECRI and CEN for the use of their UMDNS nomenclature as one component part of the development process.
• 1997 – An Ad-Hoc Project Council was established to manage the processes as required to run the coming GMDN Project.
• 1997/2001 – The GMDN Project was undertaken based on the structural standard (EN ISO 15225:2000,Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange). It defined the general structure of the nomenclature and provided the required understanding of field lengths, data relationships, etc.
  Finance for supporting this project included approximately 850.000 Euros provided by the Commission. This culminated in the production of the CEN Technical Report CR 14230.
  The project involved some 70 medical device experts from 16 countries, a Project Council of 10 members, an Expert Advisory team (the EAT) of six members and a secretarial/support team of 6. Also included, as part of the project was the design, testing, setting-up and running of a dedicated database application used by all involved. The total amount of resources used to develop the initial GMDN Technical Report was estimated to be in the region of 40 to 50 man-years and the actual cost of development to be 3 times that of the original seeding money.
• 1999 – Document GMDN(99)12Rev2 from the GMDN Project Council to CEN – Proposals for the rules of procedure for the Maintenance Agency of the forthcoming EN/report and ISO/technical report “Global Medical Device Nomenclature”. This is the document that defines the setting up of a GMDN Maintenance Agency and to which the GMDN Maintenance Agency Policy Group has adhered.
• 2000 – RESOLUTION BT 17/2000 (47BT: item 3.5) Subject: Maintenance Agencies: BT,
• considering its Resolution BT 146/1994 about guidelines for Maintenance Agencies (MA);
• considering the request from CEN/TC 257/SC1 “Nomenclature for medical devices” for such a MA on GMDN “Global Medical Device Nomenclature” which is based on EN ISO 15225 “Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange”;
• noting the involved cooperation with ISO on this subject and a possible coordination of the MA with ISO/TMB.
• 2001 – The release of the GMDN Nomenclature as the CEN Technical Report CR 14230, which is identical to ISO Technical Specification ISO TS 20225. This was the remit of the GMDN Project Council.
• 2001 – The establishment of the GMDN Maintenance Agency Policy Group to be responsible for future management of the GMDN and to develop and distribute the electronic version of the GMDN and all future versions of the datafile.
  BSI as delegated by CEN has recognized the GMDN Agency to be the formal body for the ongoing management and control of the GMDN on a global basis.

The GMDN Agency has therefore exercised and will continue to exercise the sole rights to develop and distribute all versions of the GMDN and associated data, terminology, and supporting databases.