The Global Medical Device Nomenclature (GDMN) Agency has welcomed the 1 January introduction of the UK-wide Medical Device Information System (MDIS), which now requires medical devices sold in the country to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
The GMDN Agency is a non-profit organisation that manages and maintains the GMDN, an international database that categorises and classifies all of the world’s medical devices.
GMDN Agency CEO Mark Wasmuth described the move as a “huge boost for international harmonisation as well as leading to a valuable resource for the UK healthcare sector”.
In 2019 the MHRA implemented the compulsory use of the GMDN for all low-risk device registration, as required by existing European single-market directives. The new MDIS now means that every medical device in the UK will be identified by law using the GMDN, in line with countries like the US, Canada and Russia.
While most of the world uses GMDN, the EU has ruled that all medical devices in the territory will instead come to be registered on a new system it will develop later this decade.
Wasmuth said: “With millions of medical devices being manufactured around the world, most with long and complicated names, it is often hard to know if two devices do the same function or something different. That is huge problem when it threatens patients’ wellbeing if the wrong equipment is ordered or, worse, used. Bar codes do not help here, and so this danger is overcome through having a consistent and clear form of naming – a nomenclature.
“I expect to see [a] growing number of MedTech businesses using this MDIS database as a valuable resource because the GMDN enables the data to be easily analysed, and also compared with devices used in other countries.”
Pooling medical device data in this way could make expanded reliance on the GMDN in the UK particularly useful for epidemiological studies, as it would allow clinicians to easily compare the clinical data of equivalent devices.
Wasmuth said: “Better data makes for better decisions. The MHRA’s database will also be accessible to the public to meet the growing need of stakeholders to find more accurate information about the devices they use, and supports recommendations from the recent Cumberlege review on effective medical device regulation.”