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

Why the need for Medical Device names?

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

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

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

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

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

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. 12345678909874) Device Group = GMDN Term All suppliers use same code (e.g. GMDN Code 47017) 19876543218976 32345678908765 Brooks Woods Hudson 12345678909874 Hudson 12345678909874 8

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

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

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 www.gmdnagency.org

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