1. UDI and the GMDN (Global Medical Device Nomenclature)
Mark Wasmuth
Secretary General
GMDN Agency

2. Contents Background to GMDN & GHTF Development of GMDN Codes
Scope of GMDN
Who uses GMDN and why
GMDN Data Structure
Using GMDN Database
GMDN and UDI

3. Need for Harmonisation
Provide consistent application of regulatory principles and approaches
Improves regulatory system efficiency and effectiveness
Reduces duplication
Rationalise time and cost
Allow new product / technology to enter market place
Create transparency
Regulatory programmes are expected to:
Use available international standards
Proactively influence their development
Consult with stakeholders

4. Global Harmonisation Task Force
Voluntary group established in 1992
Founding Members: USA, EU, Canada, Australia, Japan
Partnership between regulators and industry
Liaison with:
Asia Harmonisation Working Party (AHWP)
World Health Organisation (WHO)
Pan American Health Organisation (PAHO)
International Standards Organisation (ISO)

5. GHTF Purpose Encourage Regulatory Convergence Promote innovation
Facilitate Trade
Information exchange forum
Study Groups established
More at

6. Role of Global Nomenclature
Global Medical Device Nomenclature
Single nomenclature for GHTF regulatory Model
Provides Generic terms with definitions
For efficient exchange of information between regulators and others
Analysis of data supports patient safety

7. Nomenclature – Pre 1993 No Consistency in Regulation (pre 1990)
Europe, USA, Canada, Japan, Australia and many other parts of the world have little or no established regulations
Result = Initiative to investigate global procedures
Conference In Brussels (Autumn 1991)
To explore existing MD nomenclatures
Result = No conclusion!
First Formal Meeting of GHTF in Tokyo (1993)
To establish a consistent approach to GMP, by using as a basis ISO 9001 as the reference for regulations, introducing the use of Quality Systems
Need for Global Nomenclature identified

8. GMDN Source Nomenclature
Baseline data was adopted from established Nomenclature:
ECRI - UMDNS
FDA - Procodes
ISO 9999
EDMA
JFMDA
NKKN

9. GMDN Development 1993 – 2011 International Standard structure
Resulted in ISO 15225:2000
Updated as ISO 15225:2010
Development to date:
18,933 Preferred Terms
1,980 Collective Terms (Device Attributes)
16 Categories (Scope)
Translation to 23 languages (ongoing)
Web-based access

10. GMDN Categories (Scope)
Active implantable devices
Anaesthetic and respiratory devices
Dental devices
Electro mechanical medical devices
Hospital hardware
In vitro diagnostic devices
Non-active implantable devices
Ophthalmic and optical devices
Reusable devices
Single-use devices
Assistive products for persons with disability
Diagnostic and therapeutic radiation devices
Complementary therapy devices
Biologically-derived devices
Healthcare facility products and adaptations
Laboratory equipment

11. Use of GMDN
The GMDN is requested by the Medical Device Regulator when products are registered in a country
The introduction of UDI has required us to standardise on GMDN
The GMDN is also being used by hospitals to reference their inventory
Governments use GMDN to analyse the expenditure on Medical Devices
The EU is implementing a data exchange system (EUDAMED) that collects information on Medical Device failures

12. EUDAMED
European commission commenced development of European Database for Medical devices (EUDAMED) to establish reporting link between all European Union regulatory bodies + EFTA countries.
EUDAMED is an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission and the Competent Authorities in the European Union Member States.
More information on EC website

13. Adoption of Nomenclature
The following countries require the use of GMDN for product registration (known about):
Australia
Japan (local variant)
Italy
Greece
Poland
Czech Republic
Turkey
Croatia
Peru
Mozambique
Other countries are planning or in the process of adopting, so we are in a transition period!

14. GMDN – Members by Country 2009

15. GMDN – Preferred Term Structure
Term Name
Code
Definition
Non-evacuated blood collection tube IVD, EDTA
57900
A non-evacuated sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant ethylenediaminetetraacetic acid (EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

16. GMDN Structure GMDN is a polyhierarchical system
Preferred Terms are flat and linked to Collective Terms (device attributes and high-level terms) which are used to create polyhierarchies
Collective Terms allow searches by subject group
CTs allow analysis of the GMDN by product attribute or feature

17. GMDN – Collective Term Structure

18. Using GMDN (website access)

19. Using GMDN (searching for terms)

20. Using GMDN (selecting the term)

21. Using GMDN (multi-lingual display)

22. GMDN and UDI
GHTF (following the lead by FDA) are preparing guidance on UDI and UDI Databases (Master Data)
The GMDN is the chosen nomenclature
Part of the Master Data (not on the label)
The challenge for manufacturers:
Get your Master Data in order
Manage your UDI and GMDN Codes (ongoing)
Publish the data (where needed)

23. GMDN and UDI Relationship
Device Type = UDI
Generic Device Group = GMDN
Hudson
Hudson
Brooks
Woods

24. Summary Being used by more Manufacturers, Regulators and Hospitals
Has the necessary detail and tools to meet Stakeholder needs
Database is updated daily following Manufacturer requests for new terms and users are informed of changes
Questions?