MHRA’s New Fee Structure: What It Means for Manufacturers 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant changes to its statutory fee structure, set to take effect on 1 April 2026. These changes, particularly the introduction of a new annual fee for post-market surveillance (PMS) activities, mark a pivotal shift in how medical device regulation is funded—and they carry important implications for manufacturers across the sector. 

Why the Change? 

Historically, PMS activities—critical for monitoring the safety of medical devices once they are on the market—have been funded by grants from the Department of Health and Social Care. This model, however, was deemed inconsistent with HM Treasury’s “Managing Public Money” guidance, which mandates full cost recovery for regulatory services. 

The MHRA is transitioning to a predictable, manufacturer-funded model to ensure: 

• Financial sustainability 

• Enhanced patient safety 

• Support for innovation and faster market access 

Key Changes

1. Replacement of One-Off Registration Fee 

The current one-time registration fee will be replaced with an annual fee based on the number of GMDN Level 2 categories a manufacturer’s products fall under (See the GMDN Agency’s Guidance for Manufacturers on Identification of GMDN Level 2 Categories for more information.).  

Transition period: Subsidies will remain in place for 2025–26, with full cost recovery expected by 2027–28 

2. More Equitable Cost Distribution 

Originally the MHRA new fee structure was based on the more granular GMDN Level 5, which disproportionately impacted manufacturers with diverse product lines. Following consultation feedback, the MHRA revised the model to Level 2, ensuring less of a burden on manufacturers and more evenly spread costs across the sector.  

3. Data Cleansing Initiative 

To ensure accurate billing, the MHRA will support manufacturers in de-registering obsolete products free of charge. This will help refine the final fee calculation and reduce unnecessary costs. 

The Impact on Manufacturers 

For Small and Medium Sized Enterprises 

• Lower financial impact due to fewer product categories 

• Predictable annual costs aid in long-term budgeting 

• Opportunity to streamline product portfolios through data cleansing 

For Larger Manufacturers 

• Higher fees due to broader product ranges 

• Increased regulatory obligations under expanded PMS requirements 

• Need for strategic planning to manage compliance and costs 

For the Industry at Large 

• Improved safety monitoring through better-funded PMS systems 

• Faster approvals and updates via real-world data insights 

MHRA Fee Structure: Current vs. New
Aspect	Current Model (up to March 2026)	New Model (from April 2026)
Basis of Fee	Per application (one-off)	Per GMDN Level 2 category (recurring)
Frequency	One-time at point of registration	Annual, applied every year
Coverage	Covers all products listed in that application	Applies once for each category where a manufacturer has products (regardless of number of products within the category)
Cost Level	£240 per application (subsidized system; PMS funded by government grant)	Estimated ~£300 per category/year
Impact on Manufacturers	Low ongoing costs; only pay again if submitting new applications	Regular, predictable costs; higher burden for those with products in multiple categories
Deregistration	Not emphasized; obsolete products may remain on register	Data cleansing exercise will support deregistration (free for obsolete devices) to avoid unnecessary fees
Transition Period	The current system continues for 2025 to 1 April 2026	Annual fee applies from 1 April 2026

The Future of MHRA’s New Fee Structure

The MHRA’s fee reform is more than a financial adjustment—it is a strategic move to modernize the UK’s medical device regulatory framework. By investing in robust post-market surveillance, the UK aims to: 

• Protect patients 

• Foster innovation 

• Position itself as a global leader in MedTech development 

Important Next Steps and Deadlines for Manufacturers 

Manufacturers should begin preparing for the changes by reviewing their product registrations and engaging with the MHRA guidance. The current registration model with a 261 per application registration fee will apply until March 2026. The MHRA will now begin their data cleaning exercise and will confirm the final unit cost after the completion of the exercise.

How Manufacturers Should Prepare

• Map all products against GMDN Level 2 categories to understand potential annual fees. 

• Identify obsolete or discontinued devices. 

• Plan to deregister them at no cost to avoid unnecessary fees. 

• Ensure completing this activity before April 2026. 

What will Happen 1 April 2026 

• The new proposed annual fee is introduced: approximately £300 per GMDN Level 2 category. 

• MHRA moves to a full cost recovery model, with PMS fully funded by annual manufacturer fees. 

How MedEnvoy Can Support You 

At MedEnvoy, we recognize the extra burden that MHRA’s new regulatory fee structure places on manufacturers. Our team is here to guide you through the transition and will ensure the management of the removal of obsolete products during MHRA’s data cleansing exercise, to ensure your registrations remain accurate. Through our regulatory intelligence process, we continuously monitor MHRA developments and provide timely insights, so you are always informed of new requirements, upcoming deadlines, and potential impacts on your business. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.