3.

5 Medical devices: Nomenclature system

3.5.1. Introduction
The nomenclature of medical devices is a coding system used to generically classify and identify all medical devices
and related health products. Having a nomenclature system in place for medical devices facilitates their management
and regulation by standardizing terms that enable communication despite linguistic and other barriers. Such
standardization is currently used in some regulatory systems but is also a prerequisite for inventory management
and databases for maintenance of equipment.

Several naming systems for medical devices exist and each is used by a different group of professionals depending on
the needs of that particular group, needs such as maintenance, procurement, accounting, stock keeping, regulatory
affairs, adverse medical device event reporting and customs operations. The number of systems in existence can
make it difficult to communicate between individuals and organizations. Therefore, WHO is working towards a
unified nomenclature system that can be used globally. Currently, several countries have their own nationally used
nomenclature systems. However, the two nomenclature systems most widely used for medical devices are the
Global Medical Devices Nomenclature System (GMDN)i and the Universal Medical Devices Nomenclature System
(UMDNS)ii that are explained in more detail below.

The GMDN was developed by the European Committee for Standardization (CEN) and medical device experts
from around the world (manufacturers, healthcare authorities and regulators) based on the international standard
ISO 15225. It is managed and maintained by a not-for-profit company, the GMDN Agency, which reports to a Board
of Trustees on which medical device regulators and industry are represented. To ensure continuing permanency
of the GMDN, revenues are generated through the licensing and sale of GMDN Agency products, particularly the
GMDN codes. The GMDN is a poly-hierarchical system. Product identification is done by unique numerical five-digit
numbers that are associated with a term (medical device name), a definition that includes the intended use(s) and
the device category (based on device application, technology, or other common characteristics). Identification of
all specific medical devices having substantially similar generic features is possible through cross-referencing.

The UMDNS was developed by the Emergency Care Research Institute (ECRI). ECRI is a nongovernmental, not-for-
profit organization, governed by an Executive Committee and a Board of Trustees. The UMDNS is poly-hierarchical
and is developed as an interrelated vocabulary based on terms naming the medical devices. Terms are assigned a
5 digit code using consecutive numbering with no intrinsic meaning. The code is associated with a definition and a
description of the intended use. Associated properties provide additional attributes for classification. Maintenance
is done by a core group of ECRI nomenclature specialists, both for the ECRI’s internal use and to provide support
to external clients and licensees.

Further nomenclature systems of interest for medical device identification include, for example:
• The International Statistical Classification of Diseases and Related Health Problems (ICD)iii. ICD-10 is the
tenth revision of a WHO developed medical classification list for diseases, disorders, health symptoms, and
injuries. It serves to accurately code medical diagnoses and is employed by all member states, in for example,
epidemiology, health management and clinical settings.
• The Unique Device Identification (UDI)iv system that is being developed by the U.S. Food and Drug
Administration (FDA) to label medical devices through their distribution and use. The related Global UDI
Database will be publically accessible for download and use.
• The United Nations Standard Products and Services Code (UNSPSC)v that is an open, global, multi-sector
classification system divided in five hierarchical levels. It was developed by the United Nations Development
Programme (UNDP) and Dun & Bradstreet Corporation (D&B) in 1998 and is managed by GS1 US, a not-for-
profit organization, since 2003.

3.5.2 Global facts
The Baseline Country Survey collected information about whether countries had nomenclature systems in place
and if so, which type of system was used. In total, 174 countries responded. An overview of the results can be seen
in Fig. 3.5-1.

Fig. 3.5-1. Nomenclature systems for medical devices

About half of the responding member states, i.e. 90 countries (52%), use at least one official nomenclature system for
medical devices. In contrast, 84 member states do not have any official national nomenclature (49%; see Fig. 3.5-2).

The 90 countries who have an official nomenclature system are using the following types: 26% have developed a
system nationally, 12% use Universal Medical Device Nomenclature System (UMDNS) only, 10% use Global Medical
Device Nomenclature (GMDN) only, and 3% more than one system.

Do not have one

26% More than one system

49% UMDNS

10%
GMDN
12%
Nationally developed
3%

Fig. 3.5-2. Existence and type of the countries’ official nomenclature system for medical devices.

More than 50% of the low- to middle-income countries do not have an official nomenclature system (71 countries
from 126 responding low- and middle-income countries). In contrast, 74% of high-income countries have an official
nomenclature system (36 from 49 responding high-income countries; see Fig. 3.5-3).


 100
Nationally developed
8 (may use others)
8
16 14
80 1 More than one system

Proportion of countries (%)

1
3 6
1 3
UMDNS only
60 2 1 6
6
2
GMDN Only

40 13
Do not have

20 25
27
20
13

0
Low income Lower middle Upper middle High income N=175
income income
WHO regions

Fig. 3.5-3. Presence and type of the countries’ official nomenclature system for medical devices by World Bank
income group

More than 50% of the countries of WPR, SEAR, and AFR regions do not have an official nomenclature system. In
contrast, more than 65% of the countries of EMR and EUR have an official nomenclature system (see Fig. 3.5-4).

100
Nationally developed
7 (may use others)
2 5
14
1 5
80 13 More than one system
3 1
Proportion of countries (%)

1 3
4 1
UMDNS only
60 5 2
3
2 5 GMDN Only

40 13
31 Do not have
7
12
20
5
16 14

0
AFR AMR EMR EUR SEAR WPR N=175

WHO regions

Fig. 3.5-4. Presence and type of the respondent countries’ official nomenclature system for medical devices by
WHO regions

It can be observed that in the European (34 of 50 respondent countries), Eastern Mediterranean (7 of 14 respondent
countries), and American (17 of 34 respondent countries) regions at least 50% of the respondent countries have
an official nomenclature system and a regulatory authority. In the case of African, South-East Asia, and Western
Pacific regions more than half of the participant countries do not have any nomenclature system independent of the
existence of a national regulatory authority for medical devices (Fig. 3.5-5).


 35 34
Do not have an official nomenclature unit
Number of countries with an official nomenclature but have regulatory authority
30

Do not have an official nomenclature

neither regulatory authority within MoH
and/or national regulatory unit

25

Have an official nomenclature but

20 do not have regulatory authority

17 17
Have an official nomenclature,
and regulatory authority within MoH
15 14
13 13

10
8
7 7 7
5 5
5 4
3 3 3 3
2 2 2 2
1 1 1
0

AFR AMR EMR EUR SEAR WPR N=174

WHO regions

Fig. 3.5-5. Presence of an official nomenclature system and/or national regulatory authority for medical devices by
WHO region

Fig. 3.5-6 shows that in none of the regions do more than 30% of countries have an official nomenclature system
as well as lists recommending health technology within the ministry of health. However, in the European region
32 (71%) of 45 respondent countries, in the Eastern Mediterranean region 9 (64%) of 14 respondent countries and
in the American region 18 (55%) of 33 countries have at least an official nomenclature system. Furthermore, for
African, South-East Asia, and Western Pacific regions, more than half of the participant countries do not have any
nomenclature system independent of the existence of any list recommending health technology within the ministry
of health.

25
and/or lists recommending health technology within MoH
Number of countries with either an official nomenclature

23 Do not have an official nomenclature unit,

but have lists recommending health technology

20 20
Do not have an official nomenclature neither
lists recommending health technology within MoH

Have an official nomenclature but do not

15 have lists recommending health technology

12 Have an official nomenclature, and lists

11 11 recommending health technology within MoH
10
9 9
8 8
7
6
5
5
4 4 4 4 4
3 3 3
2
1 1
0

AFR AMR EMR EUR SEAR WPR N=162

WHO regions

Fig. 3.5-6. Presence of an official nomenclature system and/or lists recommending health technology for medical
devices by WHO regions 

The nomenclature systems are used for different purposes such as for as regulatory purposes, for procurement and/


or inventory. An overview of the types of usages in the respondent countries can be seen in Figs. 3.5-7 and 3.5-8.


 

 


 Fig. 3.5-7. Nomenclature system usage types for medical devices

1% None
6%
8%
Not Specified
4%
Regulatory and
procurement
48%
Procurement
33%

Regulatory

Inventory
N=175

Fig. 3.5-8. Distribution of nomenclature system usage types: regulatory purposes, procurement, and inventory

In most regions, the nomenclature of medical devices is used for procurement and regulatory processes. However,
in the African region, where regulatory processes of medical devices are very limited, the nomenclature systems –
when available – are mainly used for procurement. The countries of the South-East Asia region did not specify any
specific uses for the nomenclature systems (Fig. 3.5-9).

100
No

13
80 5 Not specified
Proportion of countries (%)

16 12
7
For inventory
60 31

For regulatory purposes

27 and procurement
7 7
40
For procurement
6
3
20 7 1 For regulatory purposes
1 4
5
2 1 3
1
4 3 14
1 1
0
AFR AMR EMR EUR SEAR WPR N=175

WHO regions

Fig. 3.5-9. Nomenclature system usage types for medical devices by WHO regions


Concurrently, analyzing the results by World Bank income groups shows that in high-income countries, the
nomenclature is used to a greater extent for regulatory purposes than in the other countries. In contrary, the low-
and lower-middle-income countries use the nomenclature more for procurement purposes, as regulatory processes
are limited (Fig. 3.5-10).

100
No

13
80 Not Specified
Proportion of countries (%)

26
20 25
For inventory
60

For regulatory purposes

24 and procurement
40
16 For procurement
8
10
2
20 For regulatory purposes
2 1 2
3
5
4 3 8
0 1 2
Low income Lower middle Upper middle High income N=175
income income
World Bank income groups

Fig. 3.5-10. Nomenclature system usage types for medical devices by World Bank income groups

3.5.3 Further reading

For more information about medical devices nomenclature systems, please refer to the following documents and
websites:

Documents:
• International Medical Device Regulators Forum (IMDRF) Guidance document on the UDI

Websites:
• Global Medical Devices Nomenclature System (GMDN) Agency home pagei https://www.gmdnagency.org/
• Universal Medical Devices Nomenclature System (UMDNS)ii by the Emergency Care Research Institute (ECRI)
http://www.ecri.org.uk/umdns/index.htm
• Unique Device Identification (UDI) iv by the U.S. Food and Drug Administration (FDA) page
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
• United Nations Standard Products and Services Code (UNSPSC)v page http://www.unspsc.org/

Endnotes
i. https://www.gmdnagency.org/
ii. http://www.ecri.org.uk/umdns/index.htm
iii. http://www.who.int/classifications/icd
iv. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
v. http://www.unspsc.org/
vi. IMDRF Guidance document on the UDI of medical devices, IMDRF UDI Working Group, release 9 December 2013 (http://
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf)