Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) using official global medical device nomenclature (GMDN).
The new system came into effect on 1 January 2021, with certain devices allowed a grace period for registration. Each new registration has a statutory fee of £100.
WHY IT MATTERS
Mark Wasmuth, CEO of the GMDN Agency, which manages the international GMDN database of millions of medical devices, has praised the MDIS as a “huge boost for international harmonisation” in the medical technology industry as it will lead to more accurate device identification and grouping.
The dedication to an international identification standard will enable the accelerated adoption of new devices, ensure better support in medical decision-making and maintain high safety standards.
The MDIS database will be accessible to the public, hospitals and suppliers and is predicted to be of significant value for epidemiological studies, as well as a valuable resource for stakeholders to find accurate information about the medical devices they use.
In order to register a device with the MHRA, it must be manufactured in the UK or Northern Ireland or have an appointed UK Responsible Person with a registered business in the UK. Class I medical devices, custom-made devices and IVDs are required to register immediately, with other devices awarded a grace period until either 1 May or 1 September 2021.
THE LARGER PICTURE
The move is a result of the Brexit vote, which required the UK to forge its own registration and regulation systems for medical devices. In 2019, the EU announced it would be creating its own device registration system separate from GMDN later on this decade, which the UK Government rejected in favour of a “dynamic, fit-for-the-future regulatory system capable of adjusting for future innovation”.
The compulsory use of GMDN for all medical devices brings the UK in line with other major countries in the medtech industry, such as Australia, the US, Russia, Canada and Brazil.
According to Wasmuth, “the GMDN enables the [MDIS] data to be easily analysed, and also compared with devices used in other countries. […] 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.”