Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what process is available to manufacturers to seek reassignment or review of a GMDN Level 2 classification used by the MHRA where the published description no longer reflects the device’s intended purpose.

Global Medical Device Nomenclature (GMDN®) codes and categories are managed and determined by the GMDN Agency. The structure is managed independently of the Medicines and Healthcare products Regulatory Agency (MHRA) who is not involved in assigning GMDN® codes to categories. Questions regarding GMDN® code allocations to categories should therefore be directed to the GMDN Agency.