The £261 admin fee is disappearing. But the replacement could cost you 10x more.
REGULATORY ALERT: MHRA FEE MODEL OVERHAUL
Effective Date: April 1, 2026
EXECUTIVE SUMMARY
The MHRA is fundamentally changing how it funds medical device regulation. The agency is moving from a "Transactional" fee model to a "Portfolio" fee model. This shift rewards efficient data management and penalises "ghost" registrations.
THE FINANCIAL SHIFT: FROM "ADMIN" TO "ACCESS"
The cost driver for your UK registration is changing.
Feature
Current Model (Until March 31, 2026)
New Model (From April 1, 2026)
Fee Trigger
Administrative Updates
Market Footprint
Common Cost
£261 per update (e.g., Annual Letter of Designation (LoD) renewal)
£0 for Admin Updates (LoD/Address changes are free)
New Cost
£0 for simply "holding" a registration
~£300 per year per GMDN Level 2 Category
Summary
You pay to change paperwork.
You pay to maintain categories.
THE RISK: THE "GHOST DEVICE" MULTIPLIER
Under the current rules, if you have 10 obsolete devices on your registry, they cost you nothing extra because your annual £261 LoD fee covers the whole account.
Under the new rules, every active GMDN Level 2 category triggers a bill.
The Trap: If those 10 obsolete devices sit in 10 unique categories, your MHRA fees will jump from £261/year (LoD update) to ~£3,000/year (Category fees).
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ACTION REQUIRED: THE "PORTFOLIO CLEANSE"
To optimise your transition to the new fee structure, you must complete the following before March 30, 2026:
AUDIT: Export your full registration list from DORS.
DEREGISTER: Formally remove any device no longer placed on the GB market.
OPTIMISE: Review your GMDN coding. Ensure active devices are grouped under consistent Level 2 categories were regulatory compliant.
KEY DATES
Now - March 30, 2026: Deregister "Ghost Devices" for free.
March 30, 2026: DORS system snapshot taken for fee calculation.
April 1, 2026: LoD updates become free; Annual Category Fees begin.
Need a UK Responsible Person (UKRP) to manage this transition?
Let's talk - info@euukrep.com
[EU-UK AUTHORISED REPRESENTATIVE LTD]
December 9, 2025