It is a international system used to identify all medical device products

1. Unit -1 (MRA 203T)
GLOBAL MEDICAL DEVICES NOMENCLATURE(GMDN)
Presented by:
Ms. Penamacha Anusha
1st M. Pharm (Regulatory Affairs)
Reg no: 222307
Shri Vishnu College of Pharmacy
Under the guidance of:
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs

2. CONTENTS OF PRESENTATION:
 Introduction
 Variety Of Medical Devices
 History of GMDN
 Agency Board
 Why Naming Is Important?
 Why GMDN Needed
 GLOBAL ACCEPTENCE
 GMDN Term Structure
 How Can We Find GMDN Codes?
 Searching for GMDN terms
 What’s the process?
 Collective Terms
 Unique Device Identification
 UDI requires a Carrier & Hardware
 GMDN and UDI Relationship
 Conclusion
 References

3. 1) GMDN was established in 1991
2) Global Medical Devices Nomenclature (GMDN) is a system of internationally agreed
generic description used to identify all medical device products.
3) The nomenclature is naming system for products which includes those used for the
diagnosis, prevention, monitoring and treatment of disease/injury
4) The main purpose of the GMDN is to provide health regulators, health care providers,
conformity assessment bodies and other with a single generic naming system
5) GMDN based on the International Organization for Standardization (ISO) 15225.
6) ISO started work on a global standard nomenclature for medical devices in 1996. There
are 5000 to 24000 medical devices.
7) In 2008, GMDN translated into 25 languages. There is 22000 preferred terms with
definitions. There is a free access to all GMDN terms made available following a requested
from WHO and EC in 2019.
8) GMDN has been established in line with WHO requirements for medical devices (WHO
EB152/11).
INTRODUCTION

4. Variety of Medical Devices

6. • The GMDN Agency has a Board of Trustees.
John Wilkinson - Chair of the Board of Trustees
Dr. Elizabeth D. Krell - Trustee
Dr. Christina Tong - Trustee
Janet Trunzo - Trustee
Deniz Bruce - CEO
Mark Wasmuth - Constitutional Member
Board of Trustees
• The Policy Advisory Group (PAG) provides advice to the Board of Trustees on matters
of relevance to the satisfactory maintenance of the GMDN, including:
• Ensure that the GMDN meets International requirements of regulatory bodies for
exchange of regulatory information and New and emerging international needs for
nomenclatures
PAG
• The Authorities Strategic Advisory Group (ASAG), which represents medical device
regulators and provide advice and feedback to Trustees, including:
• The promotion of the GMDN to encourage broader adoption and global harmonization
of the GMDN that underpins an efficient and effective regulatory model of safety and
performance for medical devices.
ASAG
Agency Board of GMDN

7. Why Naming Is Important?
 To trade medical device internationally
 Regulators need to approve devices
efficiently by identifying product group and
related hazards
 Regulators need to identify systemic failures
of medical devices
 Hospitals can identify the products they need
and manage their inventory
Why GMDN Needed?
 Data exchange between manufacturers,
regulators and health care authorities
 Exchange of post-market vigilance
information
 Supporting inventory controls on
hospitals
 To reduce duplicates
 Lowering poor definitions

8. GLOBALACCEPTENCE
 The Global Harmonization Task Force (GHTF) to help
accelerate GMDN. Now GHTF has now been supersede by
the International Medical Device Regulators Forum
(IMDRF)
 European Confederation of Medical Devices Association
(EUCOMED) supports the use of GMDN in meeting the
needs of European manufacturer
 WHO & MSF (Medicines' Sans Frontières) use GMDN
guidance for developing countries
 US FDA are using GMDN is the first national
implementation of Unique Device Identity (UDI)

9. GMDN Term Structure
Each GMDN term consist of 3 parts:
♦ Term Name: General-Purpose syringe
♦ Definition: A sterile device consists of a calibrated hallow cylinder and a moveable
plunger intended to be use to inject fluids into the body or various medical devices
♦ Code: 47017
Another example of GMDN:
GMDN term name - "Scalpel, single use"
GMDN Code - "47569"
GMDN Definition – “A sterile, hand-held, manual surgical
instrument constructed as a one-piece scalpel handle and blade
(not a replaceable part) used by the operator to manually cut or
dissect tissue. The blade is usually made of high-quality
stainless-steel alloy or carbon steel, and the handle is often
made of plastic. This is a single-use device.”

10. How Can We Find GMDN Codes?
 In 2005 GMDN launched official website
 We can find codes through: www.gmdnagency.org
 To find the GMDN code ,please login to GMDN account ,enter the full term name in to the search
box and follow the on screen instructions.
 If we have any problem contact to assistance to solve it.

11. Searching for GMDN terms:
You can access the full list of GMDN term by registering for an account on the GMDN agency website.
The GMDN agency is not-for-profit organisation responsible for creating and maintaining GMDN terms
What’s the process?
 Identify the GMDN Code for all of your products, from the GMDN database
 Provide the GMDN Code to your Customers / Distributors / Data Pools
 Use the GMDN Code to register your products with your MD Regulator
 Use with Unique Device Identification (UDI)

12. Collective Terms:
GMDN uses Collective Terms to provide:
 Better navigation with variable hierarchies
 Flexible to meet future needs
 Compare common features:
 Materials (Inert, Latex, Animal)
 Invasiveness (Internal / External)
 Sterility (Supplied Sterile / non-sterile)
 Use Frequency (Single Use / Reusable)
 Powered by (mains, battery, air, etc.)

13. Unique Device Identification
A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following:
•Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model
of a device.
•Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when
included on the label of a device:
• Lot or batch number within which a device was manufactured
• Serial number of a specific device
• Expiration date of a specific device
• Date a specific device was manufactured;
• Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based
product (HCT/P) regulated as a device.
The device labeler must provide the UDI in two forms on labels and packages:
• Machine-readable form that uses automatic identification and data capture (AIDC) technology.
• Easily readable plain-text
Automatic identification and data capture (AIDC):
Any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic
patient record or other computer system via an automated process.

14. An example of how to recognize a UDI on a label:

15. UDI requires a Carrier & Hardware
Product Label (Carrier)
 Linear Bar Code GMDN and UDI Relationship
 2D Bar Code (more data)
 RFID - Radio Frequency Identification (non-contact)
Hardware to read labels
 Bar code Reader
 Image Scanner
 RFID Scanner

16. GMDN and UDI Relationship

17. Conclusion:
1. The Global Medical Device Nomenclature (GMDN) is a comprehensive set of terms,
within a structured category hierarchy, which name and group all medical device products
including implantables, medical equipment, consumables, and diagnostic devices.
2. To provide a single common language for all medical technology, and for it to be adopted
by medical device regulators, manufacturers and other participants in healthcare systems
worldwide.
The GMDN is used for:
 Data exchange between manufacturers, regulators and healthcare authorities
 Exchange of post-market vigilance information
 Supporting inventory control in hospitals
 Purchasing and supply chain management

18. Questions:
1) Write briefly about GMDN and its process with an example?
2) Explain about UDI
3) Discuss about history of GMDN and why naming is important

19. References:
https://www.gmdnagency.org/Services/GMDN
https://docplayer.net/17589873-Global-medical-device-nomenclature-gmdn.html
https://www.gs1.org/docs/healthcare/Tues_10h15_MarkWasmuth_GMDN.pdf