7 April 2022

The GMDN Agency has a core role in facilitating greater harmonisation and supporting shared data to benefit regulators, manufacturers, healthcare professionals and the public.

In an idealised world, public health authorities would be able to share information at a moment’s notice and use this to gain enhanced data about the performance of medical devices.

This would enable regulators and others in the health systems industry to gain early evidence of device performance and act where needed; Early signal detection is the hope of all health system regulators. The more individual data points that are available, the earlier patterns of efficacy, malfunction or side-effects can be determined.

Innovative improvements or devices not performing as expected can be detected early and closely monitored. The prosthetic hip replacement is widely used and arguably the most successful medical device of all time, however metal-on-metal prostheses failure would have been substantially reduced through earlier detection and removal from the market. This is only possible through better linked databases, and the case is even stronger for rare-diseases or unknown malfunctions.

Individual national health systems often have an insufficient number of data points to generate meaningful conclusions about performance. Larger multi-national data pools are a necessity to determine what is happening, provide insights and drive innovation, as well as put a stop to practices and products that are not serving the best interest of patients.

In order to confidently pool like-for-like data there must be standardisation in the construction of data sets. The Global Medical Devices Nomenclature (GMDN) was established more than 30 years ago by visionary regulators, under the guidance of the Global Harmonisation Task Force (now the IMDRF), with this consideration in mind. They argued that the starting point for sharing information was the ability to identify products in an unambiguous way, and the GMDN Agency has been generating clear definitions for medical devices ever since.