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Home > News Center > Major Shake‑up in UK Medical Device Market Access! MHRA May Issue Medical Device Licences Directly in Future

Major Shake‑up in UK Medical Device Market Access! MHRA May Issue Medical Device Licences Directly in Future

Time：2026-09-02 11:23:49

On 1 September 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released an official announcement: the UK Government has tabled three regulatory‑reform amendments to the Health Bill in Parliament to modernise the legislative framework governing medicines and medical devices in the United Kingdom. As a key milestone of post‑Brexit independent regulatory reform, these amendments will reshape compliance rules for medical‑device access to the UK market from three dimensions: information‑sharing powers, streamlined legislative updates, and underlying medical‑device licensing architecture.Please note that these amendments are merely legislative proposals. They will not trigger immediate changes to existing regulatory requirements for medicines and medical devices. All provisions must go through parliamentary scrutiny, policy development, public consultation and impact assessment before implementation.

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https://www.gov.uk/government/news/mhra-regulatory-reform-amendments-tabled-in-governments-health-bill

一、Fundamental Overhaul of the Medical Device Licensing Regime

The third amendment provides statutory empowerment for the MHRA to develop a future medical‑device licensing system. It amends the Medicines and Medical Devices Act 2021 to establish the legal foundation for the domestic licensing framework.

（一）Core Directions for the Future Licensing Regime

For medical devices placed on the Great Britain market, the future regime may move away from third‑party conformity‑assessment pathways toward direct licensing issued by the MHRA, strengthening domestic regulatory capacity and system resilience.
Risk‑based review will be retained: review intensity will correspond to product risk levels to allocate regulatory resources proportionally.
The framework will be specially adapted for emerging technologies such as software as a medical device (SaMD) and AI‑enabled medical devices to deliver a modern, forward‑looking regulatory system.

（二）Transitional and Regional Regulatory Clarifications

While the new regime is being developed, the UKCA marking system will remain valid for Great‑Britain‑placed devices. The UK’s policy on international regulatory reliance and recognition stays unchanged.
Under the Windsor Framework, Northern Ireland continues to apply EU Medical Device and In‑Vitro Diagnostic Regulations, maintaining dual‑market access to both the EU Single Market and the UK internal market.

二、Empowerment Granted to the MHRA

The core objective of the third amendment is to deliver a statutory legal basis for building a future medical‑device licensing system for Great Britain (England, Scotland and Wales).

Current market‑access logic for Great Britain:

Manufacturer → EU Notified Body conducts conformity assessment → CE certificate issued → registration with MHRA → market placement (applies during transition periods).

Proposed future‑system direction:

Market access for medical devices in Great Britain may shift toward licences granted directly by the MHRA. The regulatory authority will assume direct responsibility for medical‑device market‑approval decisions, while the certification role of third‑party Notified Bodies will be reduced. This strengthens state‑level regulatory sovereignty and risk control.

Official documents set out these foundational design principles:

Risk‑based stratification remains：Review stringency aligns with device risk classes; high‑risk devices undergo rigorous assessment while low‑risk products follow simplified pathways.

Adaptation to new technologies：Dedicated mechanisms for fast‑evolving SaMD and AI medical devices will address limitations of traditional conformity assessment for frequently updated algorithms and software.

International‑reliance policy preserved：The UK will not adopt a closed‑door approach; acceptance of approvals from trusted overseas regulators will continue.

Distinction between Great Britain and Northern Ireland：Northern Ireland falls outside the scope of this new licensing regime. It will keep following EU MDR/IVDR with CE marking. Two separate regulatory systems will operate in parallel long‑term.

Key clarification：The amendment text neither repeals UKCA marking nor abolishes Notified Bodies. It only authorises the MHRA to design a new licensing regime. Future functions of Notified Bodies, transition arrangements for existing UKCA certificates and potential grace periods will be defined in subsequent consultations and implementing legislation.

三、Drivers Behind the Regulatory Reform

This reform marks a landmark step in the evolution of the UK’s independent post‑Brexit medical‑device regulation.

Reduce reliance on Notified‑Body certification capacity：Current UK Approved‑Body capacity is limited, creating bottlenecks for high‑risk‑device evaluations. Transferring licensing authority to the MHRA allows the regulator to directly control market‑gate‑keeping for patient safety and mitigate uncertainties associated with third‑party assessments.

Accommodate AI‑driven and software‑centric medical technologies：The existing UKCA framework is built on conventional conformity‑assessment workflows, which struggle to cope with frequent algorithm and software iterations. The future licensing regime aims to introduce flexible licensing‑variation and version‑control mechanisms suited to digital‑health products.

Strengthen the UK’s global regulatory standing：Building an in‑house licensing system aligns the MHRA with peer direct‑approval regulators such as FDA and TGA. It facilitates cross‑jurisdictional mutual recognition and information‑sharing and elevates UK influence in global medical‑device governance.

Close the full‑cycle regulatory loop combining pre‑market authorisation and post‑market surveillance：The UK has already strengthened post‑market controls via updated post‑market surveillance (PMS) rules and annual registration fees. The proposed licensing reform completes the pre‑market approval pillar to form an integrated end‑to‑end regulatory system.

四、The First and Second Amendments

（一）First Amendment

The first amendment grants clearer legal powers to the MHRA to share specific medicines‑ and medical‑device‑related information with trusted UK governmental bodies and global regulatory partners. This power is exercisable to advance public‑health objectives, patient safety, innovation access and regulatory effectiveness.

Robust safeguards are embedded：

Existing data‑protection safeguards remain intact; information‑sharing must satisfy statutory criteria and proportionality requirements.
Commercially‑confidential data and patient‑identifiable information continue to be protected under data‑protection law and patient‑consent rules. Safety standards will not be relaxed for regulatory‑collaboration purposes.

This change will deepen the MHRA’s integration within global regulatory networks, accelerate cross‑border safety‑signal exchange and expedite review collaboration for innovative products. It also raises requirements for global consistency in compliance data submitted by manufacturers.

（二）Second Amendment

The second amendment addresses the gap between static regulation and fast‑moving scientific‑technological progress, aiming to make medicines‑and‑medical‑device regulation more responsive to innovation, especially for AI medical devices and SaMD.

Three key mechanisms are proposed:

Automatic alignment with standards：Legislation can automatically reflect future revisions to technical standards and international guidance documents, enabling real‑time regulatory updates for smarter, more agile oversight.

Tiered‑consultation model：Targeted stakeholder engagement may apply for minor technical or administrative adjustments; full public consultation will only be required for material‑policy reforms to improve rule‑making efficiency.

Default‑into‑legislation mechanism：Specific technical, administrative or minor regulatory changes take legal effect unless Parliament objects. This ensures the UK regulatory system keeps pace with advances in medical science and healthcare technologies.

五、Industry‑wide Impacts & Compliance Guidance

For manufacturers targeting the UK market, these amendments send clear long‑term signals of regulatory transformation.

Manufacturers with ongoing UKCA projects：There is no immediate need to suspend or revise existing UKCA‑compliance plans. Valid UKCA certificates remain legally enforceable, and ongoing UKCA projects may proceed as scheduled. Organisations should add the new licensing regime to long‑term risk‑monitoring workflows and pay close attention to future public‑consultation outputs covering transition arrangements. When the future regime comes into force, certificate conversion, re‑submission of technical documentation and adjustments to compliance costs and timelines can be expected. Sufficient budget and time buffers should be reserved.

Manufacturers of AI‑enabled medical devices and SaMD：This reform carries the highest impact for your product portfolio. Future dedicated review pathways and variation‑control rules will be developed for software‑based devices. Continuous tracking of MHRA digital‑health‑related policy outputs is strongly recommended.

Manufacturers supplying both Great Britain and Northern Ireland：Maintain dual‑path compliance strategies. Track the new MHRA licensing reform for Great‑Britain‑market products, while keeping EU‑MDR‑based CE compliance for Northern Ireland. The two regimes will not merge in the short‑to‑medium term and must not be conflated.

Cost‑and‑timeline outlook：Should the direct‑licensing model be implemented, official licensing fees and revised review timelines are anticipated alongside modified technical‑documentation submission requirements. Appointment of a UK Responsible Person remains mandatory for non‑UK manufacturers and cannot be waived.

六、Conclusion

The amendments are still under parliamentary consideration. Final implementing timelines and detailed provisions remain subject to revision. Relevant enterprises are advised to monitor parliamentary progress and subsequent public consultations closely and prepare compliance contingency plans in advance. Should you require further insights, please consult Wiselink.

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