11 September 2023

Blog by John Wilkinson, Chair of the Board of Trustees at The GMDN Agency

When the GMDN (Global Medical Device Nomenclature) was established by the Global Harmonisation Task Force in the 1990’s it had very specific and well-reasoned goals. Regulators across the world were all collecting vigilance reports and categorising products according to definitions and structures established by each jurisdiction. 

The consequence of this was that sharing information about the performance of devices was very challenging and often impossible because different authorities could not be sure that the information being shared referred to the same or comparable devices.

The goal of all regulatory authorities is to ensure that the products that underpin global health systems are safe and effective. A key component of that role is the earliest possible identification of problems and having the data to support appropriate interventions. To that end, an ability to pool performance data across different jurisdictions allows earlier detection of potential issues as well as enhanced powering of data to either confirm that a problem exists or eliminate suspicion. 

Delayed decisions have potentially large implications for those patients that are affected. The decisions can be both about withdrawing products or modifying use versus allowing continued usage and associated patient benefits. Effective global collaboration and data sharing is a critical an element of both patient safety and avoidance of inappropriate regulatory actions based on suspicion but with inadequately powered data.

A globally harmonised service such as that provided by the GMDN is also hugely cost efficient. If every Regulator in the world had to develop and maintain their own set of individual product definitions and groupings of products with similar risk profiles, the costs involved would be enormous. GMDN is an efficient and highly expert resource which allows Regulators to utilise a dataset which is up to date and saves costs for them. The full GMDN is available for free to Regulators, healthcare providers and academic researchers.

The cost efficiency argument doesn’t only extend to Regulators. The medical device manufacturing industry, which must ensure that all datapoints are correctly completed as part of their regulatory responsibilities, carries the largest cost burden and penalty if there are duplicated but different demands from Regulators. One set of definitions and terms is both desirable and cost effective. The alternative is the need to establish complex and costly processes which accommodate disparate demands. All of this translates into diluted utility and higher costs which inevitably increase prices and compromise access to patients.

As time passes the GMDN Agency is also seeing an explosion of interest in using terms and definitions in procurement, supply chain management and, increasingly, data mining for a plethora of purposes.

The case for a unified global nomenclature is overwhelming so it seems strange that we are still having to make the case.  

JOHN WILKINSON

CHAIR OF THE BOARD OF TRUSTEES

John Wilkinson, OBE, was Director of Devices at the MHRA which he joined in 2012 and he served as Chair of the Executive Group of the European Competent Authority Network between 2014 and 2018. Prior to joining the MHRA, John was Chief Executive of Eucomed, the European medical technology industry association.

His earlier experience included the role of Director General of the Association of British Healthcare Industries and a number of roles in the medical devices industry, both in the UK and the USA, with Becton Dickinson and the BOC Group. These were followed by a period as Chief Executive of an early stage medical imaging company.

John holds a first degree in Zoology from the University of Aberdeen and an MBA from the University of Warwick. He was awarded an OBE for services to the medical devices industry in the 2010 New Year’s honours list.