Major Changes to UK MHRA Medical Device Registration Fees

Posted on October 28, 2025 By MDSS
MHRA

 

Call to Action in the UK database: Save money by deactivating devices that are no longer placed on the UK market.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is implementing a significant change to its fee structure for medical device registration, moving from a one-off fee to an annual charge per registered GMDN Level 2 categories. The shift will take effect from April 1, 2026.

 

MDSS is ready to support its clients in reviewing the current entries and to start a data cleansing project to avoid unnecessary authority fees.

↓ Details below ↓
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The new fee model introduces a fundamental change in how manufacturers are charged for maintaining their medical device registrations in the UK.

The Annual Fee will be based on GMDN Categories

  • Basis of Fee: The charge will be based on the number of Global Medical Device Nomenclature (GMDN) Level 2 Categories under which a manufacturer has registered products.
  • Cost Estimate: The MHRA will provide fee estimates starting in November 2025.
  • Coverage: – once per relevant GMDN Level 2 category per year, regardless of the number of individual devices or products registered under that specific category.

The following example illustrates the different GMDN levels:

GMDN Level example:
Level 1 (Device Category):  Active Device
Level 2 (Device Group): (Active) Cardiovascular Device
Level 3 (Subgroup): Cardiac Rhythm Management Device
Level 4 (Device Type): Implantable Pulse Generators
Level 5 (Preferred Term): Pacemaker, cardiac, implantable

 

To prepare for the new annual charging model, the MHRA has encouraged manufacturers to engage in a data cleansing exercise. This involves reviewing and updating registration details, particularly:

  • Deregistering obsolete or withdrawn devices before the new system is implemented. This is critical to avoid being charged an annual fee for devices no longer on the market.
  • Ensuring all registered products are correctly mapped to the appropriate GMDN Level 2 Categories.

MDSS is ready to provide an overview of all devices registered currently in the database. Together with you we can then deactivate any potential obsolete entries to avoid unnecessary authority fees in the future.