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GMDN Fee Hike? MHRA Releases Latest Statutory Fee Proposals!

Time：2026-08-19 11:19:54

On 17 August 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published its 2026 consultation paper on statutory fees. The document invites industry feedback on proposed regulatory service charges scheduled to take effect from 1 April 2027. The consultation period closes on 25 September 2026. Covering pharmaceuticals, medical devices, blood products and clinical research, the fee revision follows MHRA’s full‑cost‑recovery policy. It also introduces service‑speed improvements, guaranteed timelines and support measures for small‑and‑medium‑sized enterprises (SMEs), aiming to strengthen the global competitiveness of the UK life‑science sector.

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https://www.gov.uk/government/consultations/mhra-consultation-on-statutory-fees-2026

一、Index‑Linked 8.93 % Increase for Routine Services

Under the baseline proposal, 62 % of MHRA statutory fees will rise by an index‑linked rate of 8.93 %. This uplift offsets rising payroll, national insurance and operational costs; service scope and review workflows remain unchanged. Medical‑device‑related fees affected fall into two main groups:

（一）Combination Product Regulatory Services

All assessment and consultation fees for drug‑device combination products will increase by 8.93 %, including:

Scope‑extension applications for Conformity Assessment Bodies (CABs)
Initial and follow‑up consultations for devices containing new active substances
Consultations for devices incorporating medicinal substances from new sources or from approved manufacturers

For example, the initial consultation fee for a device with a new active substance will rise from £50,644 to £55,167.

（二）Medical‑Device Clinical Investigation Fees

Notification and assessment fees for clinical investigations across all risk classes will apply the same 8.93 % uplift:

Initial / resubmission notifications for Class I, IIa and non‑implantable / non‑long‑term‑invasive Class IIb devices
Initial / resubmission notifications for implantable or long‑term‑invasive Class IIb, Class III and active implantable devices
Statistical review for clinical investigations

As an illustration, the initial‑submission fee for high‑risk Class III device clinical investigations will increase from £32,016 to £34,875.

二、Key Change: Post‑Market Surveillance (PMS) Annual Registration Fee

The proposed annual post‑market surveillance (PMS) registration fee for medical devices draws the greatest industry attention. It funds MHRA’s end‑to‑end lifecycle oversight of marketed medical devices.

（一）Background

In June 2025, the UK amended its Post‑Market Surveillance Requirements Regulations, enforcing stricter safety oversight covering adverse‑incident reporting, field‑safety corrective actions and vigilance‑data evaluation. The PMS annual fee first launched in April 2026 at a subsidised rate of £300 per GMDN Level 2 category. Originally MHRA planned to shift to full‑cost‑recovery in 2027.

（二）Proposed New Fee from April 2027

Under the consultation proposal, the PMS annual registration fee would increase to £511 per GMDN Level 2 category, representing a 70 % rise inclusive of the baseline 8.93 % index adjustment.

（三）Phased Transition (Subsidy Retained)

To mitigate financial pressure on industry — especially SMEs — MHRA will defer full‑cost‑recovery. Government subsidies totalling £8.45 million will remain in place for FY 2027/28 and FY 2028/29, allowing a gradual transition to full‑cost‑recovery and giving manufacturers adequate adaptation time.

（四）Industry Impact Estimate

MHRA data indicates around 60 % of device manufacturers (predominantly SMEs) register products under only one GMDN Level 2 category and will therefore pay a single annual charge. Large‑volume manufacturers with multiple product categories will face substantially higher recurring compliance expenditure.

三、Structural Fee Adjustments

Apart from index‑linked rises and the PMS revision, several device‑related charges are being structurally revised to align fees with actual regulatory workload.

The most striking adjustment applies to Device Regulatory Advice Meetings: the fee jumps from £987 to £2,245, a 127 % increase. This service supports manufacturers seeking early regulatory guidance on development pathways and compliance strategy, so the cost growth will directly affect R&D budgeting.

General oversight services including GMP/GDP inspections and desk‑based risk assessments will also go up, with increases ranging from 13 %‑17 %.

四、Service Enhancements for Medical‑Device Stakeholders

Several cross‑cutting improvements within the fee consultation will also benefit medical‑device sponsors and manufacturers.

Tiered Scientific‑Advice Service：MHRA will restructure its scientific‑advice offering into four complexity tiers (High / Medium / Low / Simple). Standard reviews will take 90 working days. An expedited 45‑working‑day track will open for medium‑ and high‑complexity enquiries. Device developers may select routes according to project urgency.

SME Support Scheme：MHRA proposes a £2 million‑per‑annum waiver / voucher scheme for eligible UK‑based innovative SMEs. Qualifying companies can apply for fee relief for registration, scientific‑advice and clinical‑investigation activities. Innovative medical‑device SMEs satisfying eligibility criteria may access this support.

五、Practical Recommendations for Non‑UK Medical‑Device Exporters

Recalculate recurring compliance costs：Companies with broad UK product portfolios should reassess total projected PMS expenditure. Optimise registration, renewal and product‑withdrawal schedules to contain category‑holding costs.

Budget for pre‑submission consulting：Allocate sufficient budget for regulatory‑advice and scientific‑advice services given steep fee inflation, to avoid costly rework from unclear regulatory strategies.

Monitor transition arrangements and SME incentives：Take advantage of the phased‑implementation window. UK‑based SMEs should follow forthcoming detailed eligibility guidance for potential fee waivers.

Participate in the consultation：The consultation closes 25 September 2026. Organisations may submit feedback via MHRA’s official survey to influence the final fee regulations.

六、Conclusion

Overall, MHRA’s fee proposals implement cost‑recovery while softening industry impact through phased‑increases and continued public subsidies. Associated service improvements are expected to boost review predictability and efficiency.Chinese medical‑device companies targeting the UK market are advised to track the finalised policy closely and advance compliance planning and budget forecasting aligned with product pipelines.

For further consultation, please contact Wiselink.

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