From 1st January 2021 all medical devices placed on the market must be registered by their manufacturers with the MHRA as part of a UK-wide Medical Device Information System (MDIS).
This will provide a national resource for hospitals, patients and suppliers to identify and manage the medical technology they use.
The move is welcomed as a “huge boost for international harmonisation as well as leading to a valuable resource for the UK healthcare sector” by Mark Wasmuth, the chief executive of the GMDN Agency, the not-for-profit agency which manages and maintains the GMDN (Global Medical Device Nomenclature) international database that categorises and classifies all the world’s millions of medical devices.
In 2018 the MHRA implemented the compulsory use of GMDN for all low-risk device registrations, as required by the existing European single-market directives. It’s new MDIS means every medical device used in the UK will be identified by law using the GMDN. This is in line with other major countries such as Australia, Brazil, Canada, Russia and the USA. In addition to those legally requiring use of the GMDN, most other countries’ medical regulators expect the GMDN to be used.
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. Barcodes 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 the 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 device use in other countries. This will also make it increasingly valuable for epidemiological studies too.
“For instance, it enables the easy comparison of the clinical data for a new design of hip-joint implanted in, say, a patient in Oxford with comparable ones used in a patient in Melbourne and elsewhere. Currently this is virtually impossible, yet this sort of pooling of results reduces the time taken to introduce new medical technologies, while keeping the highest standards of safety.
“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.”
While most of the world uses the GMDN, the EU a year ago decided that all medical devices there must be registered on a new system it will create later this decade. Following the vote for Brexit, the UK Government decided not to adopt the EU’s approach and instead mandated a ‘dynamic, fit for the future regulatory system capable of adjusting for future innovation’ system for medical devices. The MDIS using the GMDN is the result of this.
