27 June 2022

Global harmonisation and patient safety was taken into consideration during the consultation. Read more about the report recommending the use of GMDN in the UK.

On Sunday 26 June 2022, the UK Government published a report following consultations on the future regulation of medical devices in the United Kingdom.

The Medicines and Healthcare products Regulatory Agency (MHRA) priorities include strengthening regulations to improve patient safety and encourage innovation.

The report shares that the majority of respondents considered the Global Medical Device Nomenclature (GMDN) the best option for medical device identification.

Government response:

“Having considered the views of respondents, the government intends to proceed with the proposal to require that manufacturers provide the MHRA with the relevant GMDN nomenclature for their medical device (including in vitro diagnostic medical devices) as part of device registration.”

“…it is the government’s view that maintaining the status quo of using GMDN nomenclature is the preferred option as it is allows for harmonisation with other major jurisdictions…”

It was noted within the consultation that the GMDN is widely used internationally and technically well-established.

“This latest announcement is great news for the medical device industry, and we are pleased to see patient safety form a key consideration in this consultation.

The resulting decision is an important step forward in improving global harmonisation and aligns with our ongoing mission to provide trusted, innovative and useful device identification for the protection of patients.” – Mark Wasmuth, GMDN CEO.