GMDN Code Selection Under the 2026 Annual Fee Regime

1. Key takeaways

Under the annual fee structure established by SI 2026/197, the GMDN code is no longer a neutral data item: it is the direct unit of fee calculation. Fees are charged per registration category — that is, the applicable GMDN Level 2 category on the first day of the relevant fee period, or the Level 1 category where no Level 2 applies. Additional devices within the same category are not charged again. The practical consequence is that code selection directly determines the number of categories in the annual fee: two registrations of near-identical products can carry very different annual costs if their GMDN codes fall into different Level 2 categories, while a broad product family mapped carefully into shared categories can be held at a single annual fee. Registration teams that used to pick GMDN terms as a formality now need to understand the category structure of the GMDN hierarchy, the tie-breaking rules that apply when codes overlap, and the sequencing rules that apply when devices are replaced. This article explains the charging unit, the official minimising rules, the risks of mis-selection and the deregistration order.

2. Legal basis

• The Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197, made 25 February 2026, in force 1 April 2026): reg 3(2), reg 3(3), reg 3(7) (definitions of fee period, Global Medical Device Nomenclature, maintenance and registration category).
• Official guidance: MHRA, DORS Fees Guidance — New fee structure from 1 April 2026 (version 3.0): where a single GMDN code appears in multiple Level 2 categories it is charged only once; where registrations overlap, the charge is calculated under the category containing the most GMDN entries; under a Level 1 category, all GMDN codes attract a single charge.

The statutory layer and the guidance layer do different jobs. Reg 3(2) and reg 3(3) fix the charging principle — an annual fee per registration category, with additional devices in the same category not charged — and reg 3(7) supplies the definitions that make the principle determinate, including the definition of registration category by reference to GMDN Level 2, falling back to Level 1. The fees guidance then resolves the edge cases the definitions leave open: a code spanning several Level 2 categories, portfolios whose registrations overlap between categories, and portfolios registered under a Level 1 category. Because MHRA calculates the minimum fee payable automatically in DORS, the guidance rules are largely self-executing; the company’s leverage lies in choosing accurate codes whose category placement keeps the portfolio compact.

3. Expert insights

Insight 1: there are three official rules for fee minimisation. The official fees guidance sets out: (1) where a GMDN code and term appear in multiple Level 2 categories, it is charged only once; (2) MHRA reviews all registered Level 2 categories to ensure charging is based on the fewest possible number of categories; and (3) where a registered GMDN overlaps with an existing category, the charge is calculated under the category with the most GMDN entries. DORS calculates the minimum fee payable automatically. Read together, these rules mean the system already works in the registrant’s favour on overlaps — the residual risk comes not from the calculation but from imprecise code choices that scatter the portfolio across categories in the first place.

Insight 2: codes must not be mis-selected to save fees. The official fees guidance also notes that, to ensure fees are only paid for devices actually manufactured and placed on the market, the guidance should be followed. Conversely, selecting a broad but inaccurate GMDN term in order to reduce the fee creates risk in data verification and in later regulatory oversight — the GMDN code is a key field MHRA uses for monitoring and for safeguarding patient safety. The saving from a looser category mapping is rarely worth the exposure: a code that does not describe the device undermines adverse event analysis, misstates the portfolio to the regulator, and can unravel precisely when the account is examined. Accuracy is the defensible baseline; sharing categories legitimately comes afterwards.

Insight 3: the order of deregistration affects the fee. The official guidance notes that where the only device in a category is to be replaced, the new device should be registered before the old device is deregistered; if the deregistration is done first, the category is emptied and subsequently registering a device in that same category will attract a new pro-rated fee. This sequencing detail is easy to miss during a product changeover, when registration actions are often handled by different people at different times. A simple operating rule — register first, deregister second, both within the same fee period wherever possible — avoids paying twice for continuity the company never actually interrupted.

4. Practical recommendations

GRZAN recommends building a GMDN selection to fee mapping table: record, SKU by SKU, the preferred GMDN code and term, the Level 2 category it falls into, whether that category is shared with other SKUs, and the annual fee attribution. The table turns fee conversations from estimates into arithmetic, and it exposes at a glance which SKUs drive categories that nothing else uses. The selection principle should be accuracy first, sharing second: first ensure the term accurately describes the device, then reduce the fee by consolidating SKUs into shared categories — never the reverse. Where two candidate terms are both accurate, prefer the one whose category is shared, and document the reasoning. Review the mapping table whenever a new SKU is launched, whenever GMDN terms are updated, and before each fee period begins, so the category count and the budget stay aligned.

5. Verification checklist

Before the next fee period, confirm each of the following items.

• □ An accurate GMDN code and term has been determined for every SKU
• □ The number of Level 2 categories covered has been counted
• □ Groups of SKUs that can share categories have been identified
• □ The register-before-deregister order has been used for device replacements
• □ Situations where codes were mis-selected to reduce fees have been excluded

Regulatory information verified as of 29 October 2026.

• Appointment of the UK responsible person (UKRP) and support for signing the letter of designation
• End-to-end MHRA registration (DORS) filing and account lifecycle management
• Device classification assessment, GMDN code selection and annual registration fee calculation
• Dual-pathway design for Great Britain and Northern Ireland, including the UK(NI) option
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance report submission
• Emergency handling of serious adverse events and field safety corrective actions (FSCA)
• Monitoring of UK regulatory changes and compliance gap assessment

Working with GRZAN. GRZAN Global supports manufacturers entering the United Kingdom market with the full scope of UKRP and fee-budgeting services described above: GMDN code and term selection for every SKU, category consolidation analysis, fee mapping and annual registration fee forecasting, and sequencing support for device replacements. For a consultation, contact us at info@grzanglobal.com.