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 MHRA has confirmed that the indicative annual fee is approximately £300 per chargeable GMDN Level 2 category (or Level 1 category where Level 2 is not available). Importantly, the fee is not charged per individual device model, but per registered GMDN category. Where multiple devices are registered under the same chargeable category, only one annual fee should apply for that category.

Estimated fees currently being issued to manufacturers are indicative only. Final payable fees will not be confirmed until after 31 March 2026, based on registration data held at that point.

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 AND AVOIDING UNNECESSARY FEES

Given the new £300-per-category annual fee, we strongly advise all members to review exactly what devices and GMDN categories they currently have registered.

In practice, some manufacturers may have multiple GMDN terms or categories registered unnecessarily, including:

• Duplicate registrations covering essentially the same device
• Legacy or obsolete device listings that are no longer placed on the market
• Slight variants or model updates that could potentially be grouped under a single appropriate GMDN category

Such duplication can artificially inflate annual fees under the new structure. Manufacturers are therefore encouraged to streamline their registrations, ensuring that:

•  Only active, relevant devices remain listed
• Devices are registered under the minimum number of appropriate GMDN categories
• Duplicate or redundant entries are removed prior to the fee assessment date

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, as these determine the number of chargeable categories. Incorrect or overly broad classification may increase fees and may also have wider implications, as GMDN data is increasingly used by NHS stakeholders for procurement and market oversight.

"PSEUDO" GMDN CODES

MHRA is currently contacting some medical device manufacturers regarding outdated “pseudo” GMDN codes that remain on their registration accounts. These codes were applied automatically when accounts were migrated to a new MHRA registration system several years ago, because older generic device descriptions were no longer supported. Under current UK medical device regulations, these temporary codes are no longer acceptable. Manufacturers who intend to continue placing devices on the Great Britain market must update their registrations by no later than 01 March 2026. This requires re-registering each device using an official GMDN® term, now a mandatory requirement, followed by removal of the legacy “pseudo” GMDN entries. Failure to take action may result in account suspension or closure, loss of visibility on the public MHRA database, and the inability to obtain Certificates of Free Sale.

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

You do not need to know the code in advance, the system lets you search by plain words (e.g. “splint”, “denture”, “mouthguard”)

ACTIONS REQUIRED FOR MANUFACTURERS OF CUSTOM-MADE DENTAL DEVICES

Manufacturers should now:

1. Audit all registered devices and GMDN categories before 30 March 2026
2. Remove duplicate, obsolete, or unnecessary registrations to avoid inflated fees
3. Confirm correct GMDN term and category assignments
4. Ensure DORS account information is current and accurate
5. Review MHRA fee guidance and assess the potential budget impact of the new annual charges
6. Establish internal processes for timely annual review and payment
7. Monitor MHRA communications and forthcoming recorded guidance