MHRA CONFIRMS NEW ANNUAL REGISTRATION FEES FOR CUSTOM-MADE DENTAL DEVICE MANUFACTURERS

The Medicines and Healthcare products Regulatory Agency (MHRA) has begun contacting manufacturers of custom-made dental devices to outline significant changes to UK medical device registration fees due to come into effect on 1 April 2026. The new charges will be calculated and paid via the Device Online Registration System (DORS), and manufacturers will have 90 days from 1 April each year to submit payment.

The move forms part of a wider programme to support post-market surveillance and strengthen device safety across the UK system. Manufacturers are being urged to begin preparations now to ensure compliance ahead of the deadline.

NEW FEE STRUCTURE AND TIMELINES

Under the new framework, annual fees will be determined by the number of chargeable Global Medical Device Nomenclature (GMDN) Categories registered with the MHRA. The estimated fees currently being issued to manufacturers are indicative only, and payable fees will not be confirmed until after 31 March 2026, based on final registration data.

Manufacturers are explicitly instructed not to make payment on estimated invoices issued by the MHRA.

Payments will open through the DORS platform on 1 April 2026, and affected organisations will have 90 days to complete payment.

Full information on fees and routes to payment is included in MHRA's online fee guidance.

WHO MUST PAY THE FEES?

Fee estimates and reminder communications will be provided only to:

• UK-based manufacturers with a registration status of 'Registered'
• UK Responsible Persons (UKRPs) representing non-UK manufacturers with a registration status of 'Registered'
• Northern Ireland Authorised Representatives acting for non-EU manufacturers with a registration status of 'Registered'

UKRPs and Northern Ireland Authorised Representatives will be responsible for collecting fees from their represented manufacturers and submitting payments via DORS.

Accounts with a status of 'Suspended' must follow specific actions detailed in the MHRA guidance.

IMPORTANCE OF ACCURATE DEVICE DATA

Manufacturers are being advised to review their account information, device listings, and supporting data prior to 30 March 2026 to ensure fees are calculated accurately. The MHRA has stressed that changes made to registrations before this date may affect final fee levels.

The guidance encourages manufacturers to undertake proactive data auditing and engage early with the MHRA's resources, including its forthcoming recorded presentation addressing common questions.

IMPACT OF GMDN CATEGORIES ON FEES

The MHRA's fee model is based on GMDN Level 2 Categories (or Level 1 where Level 2 is not available).

Manufacturers must ensure accurate assignment of GMDN Terms for each device, as these determine the number of chargeable categories.

The GMDN Agency notes that incorrect classification may have broader consequences beyond compliance, with GMDN data increasingly used by NHS stakeholders for procurement decisions.

IDENTIFYING GMDN LEVEL 2 CATEGORIES

To support industry preparation, the GMDN Agency provides user guides and training videos via its dedicated training portal, which may help manufacturers review classifications ahead of the MHRA's deadlines.

Training - Videos & User Guides - GMDN  

The GMDN Agency has issued separate guidance to support manufacturers in identifying Level 2 categories used by the MHRA.

Key points include:

• GMDN Terms are mapped to multiple categories, grouped under headers, including "Device Function"
• Under Device Function, there are 22 Level 1 Categories, each with multiple Level 2 Categories
• Some Terms link only at Level 1 or across multiple categories
• Manufacturers should review GMDN assignments regularly as part of quality processes

Manufacturers with a GMDN membership can access category data directly through the "My Terms" section of their online account.

Basic GMDN memberships do not provide access to category data.

ACTIONS REQUIRED FOR MANUFACTURERS

Manufacturers should now:

1.  Review MHRA's fee guidance and determine how the new framework will impact annual budgets
2. Audit all device listings for accuracy before 30 March 2026
3. Confirm correct GMDN Term and Category assignments
4. Ensure DORS account information is current and accurate
5. Identify internal workflows for timely annual submissions
6. Monitor MHRA communications and update subscription preferences

The MHRA is inviting feedback on the published guidance and will publish a recorded presentation to clarify common queries.