PV Bulletin

MHRA Statutory Fee Changes for 2027

The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on updates to statutory fees effective from April 2027, including significant increases for post-market surveillance and other services.

Primary source: MHRA consultation on statutory fees (2026)

PV Impact Brief

MonitoringConfidence: high

What changed

The consultation outlines proposed updates to statutory fees, including increases and a refund mechanism for delayed services, with a consultation deadline of September 25, 2026.

Why it matters

Manufacturers and sponsors of medical devices must prepare for the potential financial impact of increased fees, especially the post-market surveillance fee rising from £300 to £511, as these changes could affect operational budgets and regulatory timelines.

Action needed

Stakeholders should assess the proposed changes to the fee structure and provide feedback by September 25, 2026. This includes understanding the implications of the new fee levels and service standards on their compliance efforts.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-09-25.

Policy change details

Document type
Consultation
Policy status
Consultation
Publication date
2026-08-17
Consultation deadline
2026-09-25
Policy change
The MHRA is seeking feedback on proposed updates to its statutory fees for 2027, aimed at recovering the costs of regulatory services. Significant proposals include a phased update to the medical devices post-market surveillance (PMS) fee and adjustments to scientific advice and service standards.

Key changes

Proposed indexation-based increase for most fees. Introduction of a phased update to the medical device post-market surveillance fee. Enhanced service standards and timeline guarantees for selected services. Improvements to the MHRA's scientific advice service.

Affected workflows

Country Compliance

Responsible groups

Regulatory AffairsPV OperationsFinance

PV impact

Medical device manufacturers and sponsors should assess the impact of the proposed post-market surveillance fee changes on their operational budgets. The enhanced service standards may lead to more predictable timelines for device vigilance and regulatory interactions in the UK.

View regulator source

Source document details

Exact policy details

Consultation Close Date
25 September 2026
Applies to: All stakeholders involved in the regulatory fee change process.
This consultation closes at 11:59pm on 25 September 2026. · p. 1 · High · Source
Proposed Fee Update Effective Date
1 April 2027
Applies to: All fees regulated by the MHRA applicable from this date.
The proposals are intended to come into force on 1 April 2027. · p. 3 · High · Source
Increase Percentage for Most Fees
8.93%
Applies to: 62% of MHRA’s statutory fees which will increase by indexation.
The proposed indexation increase is 8.93%. · p. 6 · High · Source
Targeted Increase for Higher-Value Services
Approximately 27%
Applies to: 9% of MHRA’s statutory fees where higher-value, time-sensitive services are required.
These fees will increase by around 27%, including the 8.93% indexation increase. · p. 7 · High · Source
Regulatory Refund Mechanism
Rebate for Not Meeting Guaranteed Timelines
Applies to: Applicable to selected high-value, time-sensitive services.
If the MHRA does not meet the guaranteed timeline, the performance-related part of the targeted fee increase will be returned to the applicant. · p. 8 · High · Source
SME Support Scheme Cap
£2 million annually
Applies to: For eligible small and medium-sized enterprises accessing MHRA services.
The new SME support scheme will be subject to an annual cap of £2 million. · p. 10 · High · Source
Post-Market Surveillance Fee Increase
From £300 to £511
Applies to: For medical devices annual post-market surveillance registration from 1 April 2027.
The proposed fee from 1 April 2027 is an increase from £300 to £511. · p. 13 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 17, 2026

Full briefing

Practical implication

Stakeholders should assess the proposed changes to the fee structure and provide feedback by September 25, 2026. This includes understanding the implications of the new fee levels and service standards on their compliance efforts.

The MHRA is conducting a consultation to gather feedback on proposed updates to its statutory fees from April 2027. Key proposals include an 8.93% increase in most fees and a targeted increase of approximately 27% for certain higher-value services. Additionally, a new regulatory refund mechanism is proposed for cases where the MHRA fails to meet guaranteed timelines. The consultation is open until September 25, 2026.

What changed: The consultation outlines proposed updates to statutory fees, including increases and a refund mechanism for delayed services, with a consultation deadline of September 25, 2026.

Why it matters: Manufacturers and sponsors of medical devices must prepare for the potential financial impact of increased fees, especially the post-market surveillance fee rising from £300 to £511, as these changes could affect operational budgets and regulatory timelines.

Practical implication: Stakeholders should assess the proposed changes to the fee structure and provide feedback by September 25, 2026. This includes understanding the implications of the new fee levels and service standards on their compliance efforts.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Medicines and Healthcare products Regulatory Agency (MHRA)#policy-change#consultation#Guidance#firecrawl-policy-agent#Regulatory Changes

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Atellica CH Revised C-Reactive Protein (RCRP) Safety Information - Siemens Healthcare Diagnostics

Urgency: High

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward