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United Kingdom Medical Device Registration Fees
MHRA government fees for 2025
GBP 261
Low Risk Min
GBP 261
High Risk Max
MHRA
Authority
2025-12-16
Last Updated
United Kingdom (MHRA) Fee Overview
UK MHRA fees are among the lowest globally at just £261 (~$330) per application. The UK accepts CE marking until June 2028, after which UKCA marking will be required. The MHRA is planning a new fee structure for 2026 which may increase costs. Currently one of the most affordable regulatory markets for medical devices.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Registration Fee (until March 2026) | £261 | Per application |
Annual Fee (from April 2026) New fee structure starting April 2026 | £300 | Annual per GMDN category |
Regulatory Advice Service Optional service | £987 | Per 1-hour meeting |
Key Facts About MHRA Fees
- 1Application fee: £261 per device
- 2SME reduced fees available
- 3CE marking accepted until June 2028
- 4UKCA transition underway
- 5Annual charges may apply
Important Notes
- •Current fee: £261 per application
- •Major change April 2026: £300 annual fee per GMDN category
- •~60% of manufacturers expected to pay single charge
- •UKCA marking transition ongoing
Tips for United Kingdom Registration
- 1Take advantage of low fees before 2026 changes
- 2CE mark acceptance extends transition period
- 3Apply for SME fee reductions if eligible
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with MHRA.