29 August 2024

The GMDN Agency has published its latest white paper titled “Medical Device Nomenclature – What Next Globally?” 

This comprehensive document delves into the critical need for a standardised medical device nomenclature system to address the rapidly expanding global market for medical devices.

A nomenclature of medical devices is a system designed to generically name and group all medical devices and related health products. According to the World Health Organisation (WHO), there are between 5,000 to 24,000 different groups of medical devices, ranging from simple to complex, and from inexpensive to costly. The number and types of devices are increasing exponentially.[i]

The white paper explores the necessity of robust data tools to manage this challenge, emphasising the importance of a standardised medical device nomenclature. It discusses the absence of a single global standard and the reasons why existing nomenclatures have not been mapped. The paper provides an in-depth analysis of the current prominent medical device nomenclatures, including the Global Medical Device Nomenclature (GMDN), European Medical Device Nomenclature (EMDN), United Nations Standard Products and Services Code (UNSPSC), and Universal Medical Device Nomenclature System (UMDNS), highlighting their key features and differences.

Deniz Bruce, CEO of the GMDN Agency, commented on the publication:

“The safety and efficacy of medical devices are paramount in healthcare. An effective nomenclature system is essential to ensure quality in device-to-term assignment. This white paper addresses the critical questions surrounding medical device nomenclature and provides a roadmap for achieving and maintaining high-quality data standards.”

The paper also provides a summary on the topics of nomenclature standardisation and mapping, shedding light on the usage of existing nomenclatures and emphasising the importance of data quality for all stakeholders, including manufacturers and labellers. It poses critical questions that should be addressed when considering the approach to medical device nomenclature, such as the ‘nomenclature dilemma’ and the requirements for achieving and maintaining high-quality device-to-term assignments.

[1] https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/nomenclature