UK MHRA 2026 Guidance on Medical Device Registration Fees

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued its 2026 DORS Fees Guidance, introducing an annual device registration fee for medical device manufacturers placing products on the UK market. This update replaces one-off registration fees with a sustainable yearly model based on GMDN Level 2 categories. Understanding these changes is critical for maintaining MHRA compliance, managing regulatory budgets, and ensuring uninterrupted UK medical device registration under the new framework.

Key Changes in MHRA DORS Fees Guidance 2026

The 2026 update changes how registration fees are calculated and paid:

• Annual fees replace single application charges.

• Fees are based on GMDN Level 2 categories (or Level 1 where applicable).

• Manufacturers pay one fee per category, even with multiple devices.

• MHRA will calculate fees automatically each year on 1 April.

• The DORS portal will close for updates on 30 March 2026 before the new system goes live.

Official MHRA DORS Fees Guidance (PDF)

Impact on UK Medical Device Manufacturers

This change shifts cost planning from a one-time process to an annual budgeting cycle. Manufacturers with large or diverse portfolios may face higher recurring costs but gain predictable fees aligned with ongoing MHRA oversight.

Key operational impacts:

• Annual invoices must be paid within 90 days (no instalments).

• Non-payment leads to account suspension and removal from the Public Access Registration Database (PARD).

• Suspended accounts cannot place devices on the UK market or request Certificates of Free Sale.

How to Prepare Before March 2026

To avoid compliance disruption, MHRA advises early preparation:

1. Review and Clean Up Registrations

• Unregister obsolete or inactive devices.

• Update GMDN codes, UDI data, and product details.

2. Confirm Organisational Information

• Check company name, address, and contact info in DORS.

• After April 2026, such updates will no longer incur a fee.

3. Finalize Draft Applications

• Submit or delete draft DORS entries before 5:00 pm, 30 March 2026.

• The DORS system will be offline for transition until April 1.

Fee Calculation and Payment Details

• MHRA determines annual fees using GMDN Level 2 categories per manufacturer.

• Invoices are visible in DORS starting 1 April each year.

• Accepted payments: WorldPay, BACS, or CHAPS via DORS.

• Payments outside DORS are not accepted.

If a device is added mid-year, a pro-rata fee applies based on the remaining days in the annual period.

Administrative Simplifications

From April 2026, the following fees are removed:

• No fee for changing organisation details (name or address).

• No fee for uploading Letters of Designation for UK Responsible Persons or NI Authorised Representatives.

These changes streamline compliance for international manufacturers managing multiple entities or locations.

Key Takeaways for Manufacturers

Strategic Implications for Regulatory Teams

The DORS annual fee structure marks MHRA’s transition to a lifecycle funding model that reflects post-market responsibilities and device surveillance.
For manufacturers, this underscores the need to:

• Integrate registration maintenance into annual compliance cycles.

• Streamline device portfolios for cost efficiency.

• Track MHRA communications for fee estimation and category updates.

Learn more about MHRA UK Medical Device Registration & Approval.

Conclusion

The MHRA DORS Fees Guidance 2.0 introduces predictable annual costs but demands more active portfolio management. Manufacturers who prepare early — by auditing device data, cleaning up registrations, and budgeting for annual payments — will ensure seamless compliance and uninterrupted market access in the UK from April 2026 onward.

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