Primary source: MHRA consultation on statutory fees (2026)
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.
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.
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.
Regulatory Intelligence Lead
Review before 2026-09-25.
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.
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.
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.
Published from the Firecrawl policy change extraction pipeline.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
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Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.
