1. Global Medical Device Nomenclature (GMDN)
Mark Wasmuth – CEO, GMDN Agency

2. Why the need for Medical Device names?

3. Consistent naming is important
Regulators need to:
Identify the products on their national market
Speed up Pre-market approval
Information on imports and exports
Identify trends in new equipment use
Identify individual and ‘systematic’ failure types
Healthcare Providers need to:
Identify the products they use
Manage their inventory more efficiently
Identify the most effective devices
Medical Devices are traded internationally
we need a global system for naming

4. The GMDN is a global harmonizing standard
Why we need the GMDN
Existing (national) nomenclatures:
Too vague with poor definitions
Too rigid structure – difficult to amend
Can’t keep up with volume of innovation
Too many duplicate descriptions
Usually Single language
Uncontrolled – no updating method for users
Unsustainable funding models
Not suitable for international harmonisation
The GMDN is a global harmonizing standard

5. What are the benefits of using the GMDN
Used by 90 national Medical Device Regulators
Has over 7000 Manufacturers registered worldwide
Translated into 24 languages
24,000 product descriptions with detailed definitions
Controlled distribution and updating
Up-to-date with latest medical technology
Support for transition from other nomenclatures
Funded by Manufacturers who benefit from reduced costs of compliance
The GMDN is available now

6. The GMDN is widely used by many countries today
Who uses the GMDN
US FDA require GMDN in their national regulation of Unique Device Identification (UDI Rule)
European Commission uses the GMDN for their current market surveillance database (EUDAMED) and are evaluating use for their new regulation (MDR & IVDR)
The WHO use the GMDN in their publications
Widely supported by device Trade Associations (GMTA, DITTA, Advamed, MedTech Europe, etc) in promoting global harmonisation & reducing costs of compliance
The GMDN is widely used by many countries today

7. GMDN Term Structure Each GMDN Term consists of 3 parts:
Term Name General-purpose syringe, single-use
Definition “A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both)…”
Code 47017 7

8. The GMDN and UDI work together
The GMDN Code is not the same as the UDI!
Device Type =
Unique Device Identifier
From a single supplier
(e.g )
Device Group = GMDN Term
All suppliers use same code
(e.g. GMDN Code 47017)
Brooks
Woods
Hudson
Hudson 8

9. Failure Mode – GMDN Term group
GMDN CT
GMDN
Code
UDI
% Failure*
1112
33719 A
1.3 B
1.5 C
1.0 D
1.7 E
1.2
33694 F
3.2 G
4.1 H
4.5 I
3.8 J
3.5
33181 K
1.8 L
1.6 M N
1.4 O
Example - Metal-on-Metal Hip Implants
* Simulated failure data

10. Failure Mode – Manufacturer group
GMDN
Code
Make
UDI
% Failure*
36197
Jones A
1.3 B
1.5 C
1.0 D
1.7 E
1.2
Smith F
3.2 G
4.1 H
4.5 I
3.8 J
3.5
Brown K
1.8 L
1.6 M N
1.4 O
Example – PIP Breast Implants
* Simulated failure data

11. Join us at www.gmdnagency.org
Who is the GMDN Agency?
An independent, non-profit, UK Registered Charity
Responsible for maintaining the GMDN
Set-up by Regulators (GHTF / IMDRF / AHWP)
Governance:
Board of Trustees
Policy Advisory Group – guided by:
Regulators
Healthcare Providers
Manufacturers
Join us at

12. It’s all about sharing information!