UK MHRA 2026 Regulatory Overhaul: CE Mark Recognition, DORS Fees, Clinical Trials Framework, and What Manufacturers Must Do

The Most Significant UK Regulatory Shift Since Brexit

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is implementing multiple concurrent regulatory changes in 2026 that will reshape how medical devices access the Great Britain market. These changes are not incremental adjustments — they represent a fundamental reconsideration of the UK's post-Brexit regulatory framework.

At the center of these changes is the MHRA's consultation on whether to indefinitely recognize CE marked devices in Great Britain, a proposal that could eliminate the long-anticipated mandatory transition to UKCA marking. Alongside this, the MHRA has introduced annual device registration fees, a new clinical trials framework, and published draft Medical Devices (Amendment) Regulations 2026 for public comment.

For any manufacturer currently selling or planning to sell medical devices in Great Britain, understanding these changes is essential for market access planning, regulatory budgeting, and compliance strategy.

Change 1: Indefinite CE Mark Recognition Consultation

Background

Since Brexit, CE marked devices have been accepted in Great Britain under transitional provisions. The current timeline:

After those deadlines, full UKCA conformity assessment was expected to become mandatory — meaning manufacturers would need a UK Approved Body assessment and UKCA marking, duplicating the CE marking process for EU market access.

The Consultation

On February 16, 2026, the MHRA launched a targeted consultation on the long-term recognition of CE marked medical devices in Great Britain. The consultation closed on April 10, 2026, and the outcome is pending.

The MHRA proposed two options:

Option 1: Indefinite recognition for all MDR/IVDR-compliant devices All CE marked devices compliant with EU MDR or IVDR would be accepted in Great Britain indefinitely, without requiring UKCA marking. EU conformity assessment decisions would effectively determine access to the GB market without additional UK Approved Body review.

Option 2: Recognition limited to devices classified the same or lower risk CE marked devices would be recognized indefinitely only if the device classification under UK MDR 2002 rules is the same or lower than under EU classification rules. Devices classified higher in the UK would still require UKCA assessment.

What Manufacturers Would Still Need to Do

Even under indefinite CE recognition, manufacturers would be required to:

• Register devices with the MHRA through the DORS system
• Appoint a UK Responsible Person (UKRP) if the manufacturer is outside the UK
• Comply with UK post-market surveillance (PMS) obligations
• Notify the MHRA of certificate suspension or withdrawal in the EU
• Comply with UK-specific vigilance and incident reporting requirements

Industry Response

Industry bodies have broadly supported indefinite recognition. The Faculty of Pharmaceutical Medicine (FPM) responded supporting Option 2 (same or lower classification), noting that while indefinite recognition is pragmatic and beneficial for patient access, it must be supported by strengthened MHRA oversight and proactive post-market surveillance. MedTech Europe encouraged all impacted stakeholders to respond, emphasizing the importance of a predictable regulatory framework for integrated EU-UK supply chains.

Extension of MDD Transitional Periods

The consultation also proposes extending the current transitional arrangements for MDD-compliant devices by an additional six months, aligning with EU timelines for the MDD-to-MDR transition. This would extend the acceptance of MDD-compliant devices beyond the current June 30, 2028 deadline, giving manufacturers more time to achieve MDR certification for the EU market without risking GB market access.

The Scale of CE Mark Dependence

The MHRA notes that approximately 90% of medical devices currently used in Great Britain carry CE marking. This statistic underscores why the agency is considering indefinite recognition: forcing a transition to UKCA-only marking would create massive supply disruption for a market overwhelmingly served by EU-certified products.

Change 2: New DORS Annual Registration Fees

The Shift from One-Off to Annual Fees

Effective April 1, 2026, the MHRA replaced its one-off device registration fee with an annual fee model under the Devices Online Registration System (DORS). This is a fundamental change in how manufacturers are charged for maintaining their medical device registrations in the UK.

Fee Structure

The new annual fee is £300 per GMDN Level 2 category registered. Key details:

How DORS Fee Payment Works

To pay fees via DORS, manufacturers must ensure a payment billing address is included in their DORS account. If the billing address differs from the original account address, manufacturers must update their organization details before proceeding to payment. Changes to conformité assessment evidence and new model additions are auto-approved and do not require MHRA review.

Impact on Manufacturers

The shift to annual fees means that manufacturers with large device portfolios registered across many GMDN categories will face significantly higher ongoing costs. For example:

• A manufacturer with 20 GMDN Level 2 categories registered would pay £6,000 per year
• Under the previous one-off fee model, that cost was incurred only once at initial registration

Practical Steps

1. Audit your DORS registrations — Review all registered GMDN categories and remove any that are no longer relevant. Each unnecessary category adds £300 per year.
2. Verify registration accuracy — The MHRA requires manufacturers to update and verify registrations. Ensure all device information is current before the fee calculation date.
3. Budget for annual costs — Factor the recurring DORS fees into your UK market regulatory budget.
4. Consolidate where possible — If multiple devices fall under the same GMDN Level 2 category, they share a single £300 fee. Ensure your GMDN coding is not unnecessarily fragmented.

Change 3: New UK Clinical Trials Framework

Effective Since April 28, 2026

On April 28, 2026, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 took full effect after a 12-month transition period. These reforms represent the most significant update to UK clinical trials regulation in over two decades, bringing the UK framework into closer alignment with the EU Clinical Trials Regulation.

Key Changes

Important Distinction: CTIMPs vs. Device Clinical Investigations

The CTR amendments apply specifically to clinical trials of investigational medicinal products (CTIMPs) — drug trials, not medical device clinical investigations. Medical device clinical investigations in the UK are regulated separately under the UK Medical Devices Regulations 2002.

However, the Health Research Authority (HRA) has introduced parallel updated expectations for non-CTIMPs — including clinical trials of medical devices — to support transparency, patient safety, and research integrity. Device manufacturers conducting clinical investigations should:

• Align with HRA's updated expectations for non-CTIMP research governance
• Note the 5-business-day standard review time for device clinical investigation applications (this is not new but remains the MHRA target)
• Monitor for future convergence between the CTIMP and device investigation frameworks, as the MHRA has indicated interest in harmonizing processes over time

MHRA Fee Updates for Clinical Investigations

The MHRA has also updated fees for clinical investigation applications, which vary by device class:

Change 4: Draft Medical Devices (Amendment) Regulations 2026

Overview

In May 2026, the MHRA published the draft Medical Devices (Amendment) Regulations 2026 for public comment. These regulations closely align the device regulatory framework in Great Britain with the EU MDR, EU IVDR, and the International Medical Device Regulators Forum (IMDRF) framework.

Key Provisions

International Reliance Pathway

The draft regulations confirm that international reliance will operate as a standalone route to market, allowing eligible devices to obtain a Certificate of International Reliance without UKCA marking. The pathway is limited to devices authorized in the US, Canada, and Australia. The EU is not included.

This is significant because it creates a new market access route for manufacturers who have FDA, Health Canada, or TGA approval but may not have CE marking or UKCA marking. However, the pathway's scope is limited and does not replace the need for CE or UKCA marking for most manufacturers already serving the EU market.

Alignment with EU MDR/IVDR

The draft regulations track EU MDR and IVDR requirements closely in areas including:

• Classification rules
• Essential safety and performance requirements
• Technical documentation expectations
• Post-market surveillance obligations
• Vigilance and incident reporting
• UDI requirements

Timeline

Adoption of the final regulations is anticipated in late 2026. The MHRA's impact survey (launched alongside the draft regulations) is collecting data on the practical implications for industry. The survey closes on Friday, June 19, 2026, and manufacturers are encouraged to respond to ensure their perspectives are reflected in the final regulations.

Implanting Healthcare Organization Requirements

The draft regulations introduce requirements for healthcare organizations that implant medical devices to report implant data. This is a new obligation that extends beyond manufacturers to the healthcare providers using their devices, and manufacturers should be aware that their devices may be tracked through this system.

Change 5: Faster Incident Reporting and Updated MHRA Fees

Accelerated Vigilance Requirements

The MHRA has reminded manufacturers to update their vigilance procedures to reflect faster incident reporting expectations. While the fundamental reporting obligations remain aligned with EU vigilance requirements under MDR Article 87, the MHRA is expecting more timely submissions.

Updated Fee Schedule

The MHRA has updated its comprehensive fee schedule for 2026, including:

Northern Ireland: A Different Framework

A critical distinction that manufacturers often overlook: Northern Ireland follows different rules than Great Britain (England, Scotland, and Wales).

This means manufacturers selling in both Great Britain and Northern Ireland must maintain compliance with two regulatory frameworks simultaneously. The MHRA's proposed indefinite CE mark recognition for Great Britain would simplify this significantly, as CE marking would be accepted in both regions.

Practical Strategy for Manufacturers

If You Currently Sell in the UK

1. Monitor the CE mark consultation outcome — If indefinite recognition is adopted, you may not need UKCA marking at all. But do not wait — maintain your UKCA readiness as a contingency.
2. Audit and optimize DORS registrations — Remove unnecessary GMDN categories before annual fees are calculated.
3. Update your UKRP agreements — Ensure your UK Responsible Person is prepared for the post-market surveillance obligations that will accompany indefinite CE recognition.
4. Budget for annual DORS fees — Factor the new recurring costs into your UK market financial model.
5. Review clinical investigation plans — If you are conducting device studies in the UK, align with the new clinical trials framework for faster approvals.

If You Are Planning UK Market Entry

1. Use the International Reliance Pathway — If you have FDA, Health Canada, or TGA approval but no CE marking, the new reliance pathway offers a potential route to the Great Britain market without full UKCA assessment.
2. Register via DORS early — Start the registration process well before your planned market entry to avoid delays.
3. Engage a UKRP — This is mandatory for manufacturers based outside the UK. Choose a UKRP who understands the evolving regulatory landscape.
4. Separate Northern Ireland strategy — Plan your Northern Ireland approach separately, as CE marking and EU requirements apply there.

If You Are an EU Manufacturer

1. Indefinite CE recognition would be a major simplification — Your existing CE marking would continue to provide access to the Great Britain market without UKCA duplication.
2. But UK PMS obligations remain — You must still register with MHRA, appoint a UKRP, and comply with UK-specific vigilance requirements.
3. Watch the final regulations — The draft 2026 regulations may introduce UK-specific requirements that go beyond EU MDR, particularly in post-market surveillance and clinical evidence.

Key Takeaways

1. The MHRA is considering indefinite CE mark recognition in Great Britain, which could eliminate the mandatory UKCA transition. The consultation closed April 10, 2026; the outcome is pending.
2. DORS annual registration fees of £300 per GMDN Level 2 category took effect April 1, 2026. Audit your registrations to avoid unnecessary costs.
3. The new clinical trials framework has been live since April 28, 2026, offering faster approvals and enhanced transparency for device investigations.
4. The International Reliance Pathway in the draft 2026 regulations allows market access for FDA/Health Canada/TGA-approved devices without UKCA marking, but the EU is not included.
5. Northern Ireland follows EU rules, not the GB framework — plan separately for each region.
6. Draft Medical Devices (Amendment) Regulations 2026 are expected to be adopted in late 2026, closely aligning the GB framework with EU MDR/IVDR and IMDRF.
7. MHRA fees have been updated across all service categories, including approved body audits and clinical investigation applications.