Medical Equipment: Registration
(asked on 20th February 2026) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what oversight his Department exercises over the MHRA’s use of GMDN Level 2 classifications in the registration and regulation of medical devices in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) derives most of its income from charging statutory fees for its services. Generally, wherever the MHRA provides a service for regulatory work, a statutory fee is set to recover the cost of the work involved.
This means the regulated bear the cost of regulation, and Government bodies do not make a loss which must be subsidised by wider Government and ultimately the taxpayer, including patients themselves.
This is in line with the HM Treasury guidance “Managing Public Money” which states that ‘the standard approach is to set charges to recover full costs’. The MHRA does not make any profit from statutory fees.
In 2024, the MHRA consulted on proposals regarding ongoing cost recovery, and a Government response was published in March 2025. This is available at the following link:
Going forward, the MHRA intends to update its fees every two years as regularity provides more certainty to customers and enables financial planning. This is standard practice amongst government bodies operating on a cost recovery basis.
The modified Medical Device Registration Fee will be calculated by relating staff costs for post-market work to the number of Global Medical Device Nomenclature (GMDN®) codes registered to each manufacturer. The GMDN® is a comprehensive set of terms that name and group all medical device products. The Department has an agreement with the GMDN Agency for the use of the GMDN® Codes and Categories. However, these Codes and Categories are managed by the GMDN Agency.
The MHRA, as an executive agency of the Department, may use the GMDN® Codes and Categories. It does so for the purposes of devices registration and vigilance reporting, which is essential for the MHRA’s work to implement the regulations for medical devices and in-vitro diagnostics.
There will be an annual fee for each of the GMDN® codes under which a manufacturer registers.