The MHRA (Medicines and Healthcare products Regulatory Agency) has recently released updates and announcements regarding medical device registrations and regulations for Great Britain (GB) and Northern Ireland (NI). These changes are expected to impact manufacturers, UK Responsible Persons (UKRPs), and the UK Medical Device Registration processes, with specific implications for both new and existing devices. The updates also highlight the importance of accurate Global Medical Device Nomenclature for proper classification and compliance. This blog will cover these updates in a structured manner to help manufacturers and stakeholders prepare for the changes, ensuring a smooth MHRA Device Registration process and continued compliance with the evolving Medical Device Registration requirements.
1. MHRA DEVICE REGISTRATION TIMELINE
The MHRA Device Registration updated guidance has set several key deadlines for manufacturers and UK Responsible Persons (UKRPs) to track. These deadlines affect the registration renewal process and the introduction of the new annual fee structure.
Critical Deadlines:
- March 30, 2026 – The “Clean-Up” deadline, marking the final date for reviewing and submitting registration renewals under the current zero-fee process. After this date, accounts that remain suspended will be permanently closed.
- April 1, 2026 – The introduction of the new annual fee regime. Manufacturers will be charged annually based on the number of Level 2 GMDN (Global Medical Device Nomenclature) categories their devices fall under. The old one-off registration fee system will be discontinued.
- April 1, 2026 – System Changes, where the “Renew Registration” function will be removed, and continuous account maintenance will be required for accurate fee calculation.
Manufacturers are advised to ensure timely renewals and account updates before the deadlines to avoid penalties.
2. IMPACTED MHRA DEVICE REGISTRATION REQUIREMENTS
The updated regulations introduce a host of changes aimed at improving market access, data integrity, and regulatory compliance. One of the key requirements is the appointment of a UK Responsible Person (UKRP) for manufacturers based outside the UK.
Key Changes:
- UKRP Appointment – Manufacturers based outside the UK must appoint a UKRP who will act as their exclusive representative. A formal Letter of Designation is now required.
- Fee Changes – The new fee structure introduces an annual charge based on the number of Level 2 GMDN categories rather than a one-off fee. The estimated cost per category is approximately £300 annually. Additionally, administrative updates like address changes will be free of charge after April 2026.
Custom-made Devices: A significant change includes the registration of custom-made devices. These devices must be registered within 28 days of being made available in Northern Ireland, and in Great Britain, devices previously registered under EU MDD/AIMDD must meet UK MDR 2002 requirements.
3. MHRA’S NEW ANNUAL DEVICE MHRA DEVICE REGISTRATION FEE
A pivotal update for medical device manufacturers and UKRPs is the new annual MHRA device registration fee effective from April 1, 2026. The revised fee system aims to promote sustainable cost recovery and supports enhanced post-market surveillance.
Key Features of the New Fee System:
- Annual Fee – Manufacturers will pay a recurring fee based on the number of GMDN Level 2 categories their devices fall under. This shift from a one-off payment to an ongoing annual fee will affect budget planning for manufacturers.
- Pro-Rata Fees – If a chargeable category is added during the year, the MHRA will calculate a pro-rata fee based on the number of days remaining until the next billing cycle.
- No Fees for Administrative Changes – Starting in April 2026, updating organizational details like Letters of Designation or company addresses will no longer incur a charge.
This new system will simplify registration management but will require manufacturers to maintain up-to-date records and track their GMDN categories to avoid overbilling.
4. STREAMLINED PROCESS FOR COMPANION DIAGNOSTICS (CDX)
The MHRA has unveiled plans to introduce a streamlined pathway for Companion Diagnostics (CDx) in 2026. This move aims to reduce bottlenecks in the industry and facilitate faster approval for drug-diagnostic combinations.
Expected Changes:
- Integrated Application Pathway – By Q2 2026, MHRA will implement a new pathway to streamline performance studies and clinical trials for CDx.
- Risk-Based Approach – The guidance will introduce a risk-based approach to clinical evidence requirements for various types of CDx.
This change will significantly enhance market access for manufacturers of IVD and diagnostic devices by simplifying approval procedures and aligning them with international standards.
5. AI AND MEDICAL DEVICE REGULATIONS: THE MHRA AI AIRLOCK PILOT
The MHRA has launched an innovative pilot program to regulate AI in Medicine known as the AI Airlock Sandbox Pilot. This project, launched in May 2024, tests AI systems in controlled environments to ensure safety and efficacy before being deployed in hospitals.
Key Insights:
- AI System Testing – The program tested AI systems in simulation, virtual, and real-world hospital environments, examining data bias, model drift, and human-AI interactions.
- Real-Time Monitoring – A major focus of the AI Airlock Pilot is the real-time monitoring of AI models in hospitals to track performance over time, providing valuable data on AI’s real-world efficacy and safety.
- Future Plans – The MHRA has committed to expanding the AI Airlock to include more AI cohorts, such as wearable devices and diagnostic algorithms, with Phase 2 running through March 2026.
The pilot represents a critical step in developing an effective regulatory framework for AI in healthcare, ensuring patient safety and performance monitoring.
6. THE FUTURE OF CE MARKED DEVICES IN GREAT BRITAIN
The MHRA is considering proposals for the indefinite recognition of CE-marked medical devices in Great Britain, including active implantable devices and in vitro diagnostics (IVDs). This consultation is significant for manufacturers who rely on CE marking for market access.
Proposals:
- Indefinite Recognition of EU MDR and IVDR – The MHRA plans to indefinitely recognize devices that comply with the EU Medical Device Regulation (EU MDR) and IVDR, reducing supply disruptions and eliminating the need for duplicate UKCA assessments.
- International Reliance Route – The MHRA is exploring an international reliance route for higher-risk CE-marked devices, particularly active implantable devices, allowing faster market entry without compromising safety.
This recognition would provide stability for manufacturers and healthcare providers by ensuring uninterrupted access to vital medical devices.
CONCLUSION
The MHRA’s updates for 2026 reflect a shift towards a more streamlined, efficient, and cost-effective regulatory system for medical devices. Manufacturers must familiarize themselves with these changes to ensure compliance and avoid penalties. The introduction of annual fees, new pathways for Companion Diagnostics, and the regulation of AI in medicine represent significant steps forward for the UK medical device sector. By staying ahead of these regulatory updates, manufacturers can ensure their products remain compliant and accessible in the evolving healthcare landscape.