New MHRA Guidance on Device Registration Fees 

Following its earlier announcement of the forthcoming annual device registration fee (effective 1 April 2026), the Medicines and Healthcare products Regulatory Agency (MHRA) has now published comprehensive guidance titled “Preparing for the Implementation and Management of the Device Registration Fee.” 

This guidance provides detailed instructions for manufacturers, UK Responsible Persons (UKRPs), and Northern Ireland Authorised Representatives on how to prepare for the new annual fee model and manage their regulatory responsibilities through the Device Online Registration System (DORS). 

For an overview of the fee structure and its background, see our earlier update: 
MHRA’s New Fee Structure: What It Means for Manufacturers 

What the New MHRA Guidance on Device Registration Fees Covers 

The new MHRA document serves as an operational roadmap for organizations ahead of the April 2026 implementation. 

Key Areas Addressed Include:

• New Annual Fee Model and Related Administrative Changes: 
  • Annual Fee Model: Replaces the current one-time registration fee.  
  • Letters of Designation: From 1 April 2026, UK Responsible Persons (UKRPs) and Northern Ireland Authorized Representatives will no longer pay a separate fee to upload new Letters of Designation for represented manufacturers. The current statutory fee applies until 31 March 2026. 
  • Organization Details Updates: From 1 April 2026, organizations will no longer be charged for updating their name or address in DORS. The current statutory fee applies until 31 March 2026. 

• System updates and deadlines: 
  DORS will be unavailable from 5:00 pm on 30 March 2026 while system changes are applied. All updates to device records and draft applications must be completed before this time. 

• Fee calculation details: 
  Annual fees will be based on the number of chargeable Global Medical Device Nomenclature (GMDN®) Level 2 Categories assigned to a manufacturer’s devices (See the GMDN Agency’s Guidance for Manufacturers on Identification of GMDN Level 2 Categories for more information). DORS will automatically calculate the minimum applicable fee based on registered devices as of 31 March each year. These fees are calculated pro rata and are payable at the time of application through DORS. 

• Account and data review: 
  The guidance outlines steps to verify organization and contact details, register obsolete devices, and update product data fields. 

• Estimated fee notifications: 
  The MHRA will begin issuing estimated annual fees to main account contacts from November 2025, allowing organizations to prepare for the first billing cycle. 

• Compliance and payment: 
  Annual fees must be paid within 90 days of 1 April. Non-payment will result in account suspension and removal from the Public Access Registration Database (PARD). 

How MedEnvoy Can Support 

At MedEnvoy, we are already assisting clients in preparing for the transition to the new MHRA guidance on the device registration fee structure. Our goal is to help manufacturers transition smoothly into the new annual fee regime with full regulatory compliance and minimal administrative disruption. We encourage you to contact our team for tailored support.