The following pages have been formulated by NKKN for the purpose of promoting the GMDN and providing the latest up to date information about it. This information is available in English only.
The GMDN home pages are currently hosted by BSI. Additional information can be found one www.gmdn.info, an info-site on matters related to the development of the GMDN.
Medical devices are varied and complex. An essential requirement for the healthcare environment, where the free movement of medical devices is a substantial part of world trade, is the attainment of the highest possible level of patient safety. One of the important elements being established to achieve this is the so-called Vigilance systems. This procedure establishes investigation and assessment of reported incidents where medical devices are involved which have either caused, or might have caused, death or serious injury to patients and/or health care workers.
This will relate to organizations involved in the regulatory process by which manufacturers put products on the market, for example in the European Economic Area (EEA), data concerning CE mark authorisation certificates granted, refused or withdrawn by Notified Bodies (NB). Another particularly important example concerns the protection of public health when data is exchanged about adverse incidents involving medical devices where patient's or healthcare worker's welfare can be jeopardized. These all need a system for unambiguously identifying the medical device concerned.
In addition, the bilateral mutual recognition agreements set up by the European Union with Australia, Canada, New Zealand and USA each incorporate the exchange of regulatory information.
To assure precise communication of regulatory data on a world-wide basis it is necessary to have a globally recognized system of terms to identify, analyse, track, and determine the reported events. The objective of the GMDN is to establish such a set of terms: "Generic Device Groups" that, when arranged in a data system, will facilitate electronic communication, between the EU member states and other international bodies/markets.
The European standards organization, CEN, set up a multinational project to develop a global nomenclature for medical devices. It was called the (GMDN Project). The outcome, now known as the GMDN, will help regulatory bodies and manufacturers to cooperate in the exchange of regulatory information about medical devices. This project has been funded by the European Commission with a contract administered by CEN through the British Standards Institute BSI).
The existence of a single global nomenclature for medical devices will facilitate the exchange process and help avoid confusion.
The new global device nomenclature is the copyright property of CEN and is available as an electronic file as well as a technical report. It can be ordered through BSI
The primary users and applications for the GMDN are expected to include the following:
Medical device manufacturers
Regulatory and conformity assessment bodies
Healthcare agencies
Suppliers of data management systems
(Source document: CEN/TC 257/SC 1 N 131 from 4. January 2000)
A maintenance Agency (MA) has been proposed to ensure that the GMDN project is kept up to date after the project is completed and closed down.
It is intended to be "global" (international) and that the lead is to be taken by CEN.
The experience of developers’ of existing nomenclatures indicates that the GMDN will need to be updated at frequent intervals (e.g. every 3-4 months) particularly as it initially comes into widespread international use. In addition, changes to the GMDN will be needed as new medical devices are developed and placed on the market, new applications found for existing devices and old device technologies become obsolete. Information about updating of the data will be issued as a newsletter.
In resolution BT 146/1994, the CEN/Technical Board approved the guidelines for the MA. These guidelines are also taken up in the CEN System Handbook (chapter MAINT/MA)
It is proposed that when completed the GMDN will be prepared as a CEN/ISO Technical Report titled “Global Medical Device Nomenclature” available as a document in the normal way. Separately, the nomenclature terms, definitions, codes and related data contained in the Technical Report will be marketed as an electronic database file that can be directly imported into the databases of users.
It is proposed that:
In developing the Technical Report, hereafter referred to as the GMDN, consideration was given to its maintenance by use of a MA.
As for the GMDN, the MA is intended to be “global” (international), and the lead of it is to be taken by CEN.
The MA will have the following responsibilities:
The MA to consist of:
MA Policy Group: a maximum of 14 named members each appointed for a period of 5 years.
Up to 10 of the members to be nominated from within CEN and/or ISO to encompass manufacturers’ and device users’ interests. The following regulatory bodies to be invited to each nominate one representative to the MA Policy Group, participation being voluntary.
Global Harmonization Task Force
European Commission, DG III (Europe)
Food and Drug Administration (USA)
Ministry of Health and Welfare (Japan)
At the proposal of the Secretary-General of CEN, other CEN and ISO member bodies organizations with special expertise in nomenclature and international organizations may be associated with the work of the MA. The associated organizations may each appoint one representative member. The associated member has the same status as the other members but does not participate in voting.
Ideally the MA Policy Group should have a balanced membership representative of regulatory agencies, manufacturers and medical device users
MA Experts: up to 8 named medical device nomenclature experts from organizations selected by the MA Policy Group, including
ECRI
FDA
NKKN
The MA Experts may co-opt additional medical device experts as required to assist in the development/amendment of terms and definitions.
Maintenance Agency Members
The MA shall be responsible for all functions listed in the "role of the maintenance agency" and ensuring that the procedures for maintaining the GMDN are carried out in a timely manner. The MA shall respond and comment without delay within specified time limits on MA matters and nominated members attend meetings of the MA, as required.
The MA is to be supported by a secretariat (MAS), as designated by the CEN/Technical Board.
The MAS is responsible for the administration of maintenance procedures, including voting; preparation of material for external contacts to be executed by the Secretary General of CEN; publication and dissemination of results of the maintenance procedures. The MAS is also responsible for:
