techUK analysis of the MHRA Strategy 2030
The MHRA's five-year strategy commits the agency to becoming "a fast, expert and open regulator" by 2030 and to delivering "the global standard for safe and agile regulation of MedTech and AI in healthcare". Its mission is "health and prosperity for all, through scientific excellence" (MHRA Strategy 2030).
For health tech, this is the most consequential MHRA document since the post-Brexit device reforms began. Three shifts matter most:
From one-off approval to lifecycle oversight. AI as a medical device (AIaMD) moves towards continuous real-world monitoring, expanded Predetermined Change Control Plans (PCCPs) and possible Master Files for foundation models.
From slow and opaque to fast and transparent. Service guarantees (14 days for first-in-human trials, 90 days for first licensing assessment), a "concierge" Customer Relationship Unit and real-time visibility of application progress.
From regulator to convenor. A new Centre for AI and Digital Health, statutory sandboxes, Regulatory Innovation Corridors and joint work with RIO, OLS, NICE, HDRS and CERSIs.
The strategy also positions the MHRA to use AI internally (the ARISE programme) and to rely on linked NHS data for real-time safety surveillance. Several headline reforms, including direct device assessment powers, statutory sandboxes and mandatory unique device identifiers (UDIs), remain subject to Parliament.
Priorities and objectives
The strategy sets eight priorities, each with its own objective, under one mission: "health and prosperity for all, through scientific excellence". It responds to rapid change from AI, genomics, cell and gene therapies and precision medicine, which the MHRA says challenge regulatory models built around static products and one-off approvals.
It is framed as the MHRA's contribution to the Growth Mission, the Life Sciences Sector Plan, the Industrial Strategy, the NHS 10 Year Health Plan and the AI for Science strategy. The long-range marker is the government ambition for the UK to be "a global leader in life sciences regulation by 2035".
Four shifts run through every chapter: real-time surveillance instead of periodic review; more transparency on evidence, benefit-risk judgements and agency performance; faster, more predictable pathways without lowering safety standards; and closer alignment with trusted international regulators. The MHRA describes the regulator it wants to be through six characteristics: patient-centred, high performing, trusted, scientifically excellent, collaborative and pro-innovation.
Impact on the tech industry in health
The net effect for health tech is more certainty and more routes in, something that techUK has advocated for in the past years, in exchange for ongoing post-market obligations.
What changes for health tech companies
AI as a medical device (AIaMD). The MHRA will move from single-point approval to lifecycle regulation, aligned with the National Commission into the Regulation of AI in Healthcare (report published 10 September 2026, 44 recommendations).
Expect:
Continuous real-world performance monitoring, with accountability split across developers, deployers and NHS partners.
Expanded PCCPs so pre-agreed model updates ship "without unnecessary delay".
Exploration of Master Files, letting foundation model providers share safety data once for multiple downstream devices.
Drift detection, performance reporting and supply chain transparency on general-purpose models becoming design requirements, not add-ons.
MedTech market access
Direct MHRA assessment powers would add capacity beyond Approved Bodies, with priority for AI-enabled devices, advanced diagnostics, robotics and novel implantables. Continued CE recognition and new reliance routes, including with the FDA, aim for "prepare once, use across several trusted jurisdictions".
Data and safety. Mandatory UDIs for most devices, upgraded registration systems and a first market surveillance campaign on post-market surveillance compliance raise the bar on device traceability. Real-time surveillance using linked NHS data means safety signals will surface faster.
Service and cost. Bookable submission slots, real-time application tracking and an AI protocol checker reduce uncertainty. Fees for some applications rise, offset for UK SMEs by voucher schemes.
Digital product information. Moving all product information to structured digital content by 2030 creates demand for ePI, interoperability and content management capabilities.
The MHRA as a buyer and user of tech. ARISE, the digital transformation roadmap, Yellow Card integration with the NHS App and EHRs, and tech-enabled inspections all signal procurement and delivery opportunities. Detailed overview of key priorities and commitments.
Patient-centred regulation: move "from regulation done for patients to regulation shaped with them". The MHRA notes that clinical research has not always reflected the diversity of people who use medicines and devices, patient leaflets are still largely paper-based, and Public Assessment Reports are written mainly for specialists.
Key commitments:
Publish a benefit-risk methodological framework by 2027, co-developed with patients and clinicians, starting with medicines and later extending to devices.
Identify and publish evidence gaps and priority research areas, starting with a new women's health programme.
Tackle trial under-representation with HRA, NIHR, the NHS Race and Health Observatory and the UK Clinical Research Delivery Group, using "Areas of Regulatory Interest" to signal where better evidence is needed.
Make all product information available as structured digital content by 2030, keeping paper and braille.
Formalise patient input: continue hosting England's Patient Safety Commissioner, use deliberative sessions and citizens' assemblies, and refresh the Patient and Public Involvement and Engagement Plan in 2026.
Enable more medicines to move to over-the-counter supply where evidence is robust, prioritised on safety, unmet need and outcomes.
Operational excellence: be recognised by 2030 as "a fast, expert and open regulator".
The MHRA commits to combining scientific rigour with high performance and digital innovation, so that applicants get faster, more predictable decisions and can see where their application stands.
Key commitments:
Meet, and exceed where possible, statutory targets over five years, backed by a performance framework and open reporting.
Service guarantees: initial assessment of first-in-human trials within 14 days, first assessment of licensing applications within 90 days, and scientific opinions within 90 days, with fee rebates if missed.
Higher fees for New Active Substances and clinical trial applications, reinvested in capacity, plus a voucher scheme for small UK companies.
A Customer Relationship Unit offering optional "concierge" support and bookable submission slots; an expanded Customer Experience Centre with defined response times.
Broader scientific advice, including lighter-touch options, and tighter coordination with NICE.
A digital roadmap so "companies will have real-time visibility of marketing authorisation application progress".
ARISE: AI for triage, evidence pre-screening and missing-information checks, plus an AI Clinical Trial Protocol Checker for sponsors. Humans keep decision-making.
Faster decisions on generics and biosimilars and action on single-supplier risk; publish the MHRA's own sustainability performance.
World-class safety: move to continuous, real-time safety assurance across the full lifecycle of medicines and devices. Linked hospital data and patient genomics are not yet routinely available for regulatory use. The strategy says "greater access to data must be matched by the capability to analyse it effectively", and responds to a COVID-19 Inquiry recommendation on four-nation data access.
Key commitments:
Work with HDRS, the NHS, devolved governments, industry and academia towards active, real-time surveillance using linked data across care settings; build on CPRD.
Upgrade device registration, reporting and public access systems; make unique device identifiers (UDIs) compulsory for most devices, subject to Parliament.
From 2027, a conversational Yellow Card interface, reporting through common NHS digital tools, and exploration of NHS App and secondary care EHR integration.
In 2026, assess Outcomes Based Cooperative Regulation and behavioural insights for inspections; run a first device market surveillance campaign on manufacturers' post-market surveillance compliance.
By 2030, use technology routinely in compliance and inspection.
Substantially increase criminal enforcement capacity, working with Interpol, social media platforms and online marketplaces; counter misinformation about regulated products on social media and AI platforms.
Regulatory innovation: build a joined-up innovation ecosystem that gets new products to patients sooner, with the MHRA acting as regulator and convenor across all four UK nations. Innovators face a fragmented path from development through regulation, HTA and NHS adoption. The MHRA wants to spot innovations earlier and give clear routes for products that do not fit existing frameworks.
Key commitments:
Stronger horizon scanning using data science and AI, linked to the Science Campus and a CERSI model tied to priority areas.
Support legislation for statutory, time-limited regulatory sandboxes; first focus on AI as a medical device and AI in pre-clinical testing (ADMET).
Regulatory Innovation Corridors for coordinated engagement with international regulators, industry and the health system.
Continue ILAP for transformative medicines and drug-device combinations; the Early Access Service for Devices for time-limited conditional approval where need is unmet; an Innovation Accelerator to navigate the system.
MHRA–NICE aligned pathway, running licensing and value assessment in parallel so some medicines reach patients "three to six months earlier"; integrated scientific advice with one entry point, one meeting and one payment.
Shared horizon scanning with HTA bodies through the Medicines and Medical Devices Access Initiative.
With RIO and OLS: the "Beyond ADMET" sandbox, the AdvanceGxP guidance service, Novel Approach Methodologies, formal Scientific Opinions and an AI Medicines Development Action Plan in 2027.
Advanced manufacturing work, including medicines manufacturing in space with the UK Space Agency, RIO and the Civil Aviation Authority, and neurotechnology research with ARIA.
A targeted voucher scheme giving UK start-ups and SMEs cheaper access to premium regulatory services.
Scientific excellence: be at the forefront of regulatory science by 2030, with expertise in advanced therapies, personalised medicines and AI. New evidence types such as real-world data, in-silico models and digital twins need regulatory frameworks. The UK is currently 5th globally for Phase 1 trials, and more than 3.5 million people in the UK live with a rare disease, only 5% of which have approved treatments.
Key commitments:
Secure linked health data with HDRS for pharmacovigilance, pharmacogenomics and research.
Expand assessment of in-silico evidence, publish guidance on digital twins, develop frameworks through the in-silico CERSI, and enable hybrid trials using digital twins and synthetic data.
Guidance on surrogate endpoints and novel statistical methods; faster, coordinated assessment of new diagnostics.
Prior knowledge platforms so developers reuse core requirements (antisense oligonucleotides, AAVs, CAR-T, mRNA, cancer immunotherapies).
A more flexible framework for rare disease therapies through the Rare Disease Consortium, which includes patients, academia and industry.
Rise from 5th to 3rd globally for Phase 1 trials by 2030 via a stepwise 14-day first review, combined review with HRA, AI-supported document review, and human-relevant methods such as organoids and organ-on-a-chip.
System alignment with HRA, NICE, the NHS, OLS, NIHR and HDRS, including an ILAP review, a dementia pipeline and faster HealthTech access through NHAP.
Maintain NIBSC and WHO standards at the Hertfordshire Science Campus, with a long-term laboratory infrastructure plan.
MedTech and AI: "deliver the global standard for safe and agile regulation of MedTech and AI in healthcare" by 2030. The MHRA has "begun a major programme of MedTech regulatory reform", covering post-market surveillance, proposed pre-market legislation and international reliance. For AI, it recognises that performance can change across time, settings and populations, and that foundation models create new challenges. Its approach aligns with the National Commission into the Regulation of AI in Healthcare.
Key commitments:
Subject to Parliament, powers for the MHRA to carry out device assessments directly (today only Approved Bodies can), prioritising AI-enabled devices, advanced diagnostics, robotics and novel implantables.
A regulatory advice service giving earlier clarity on pathways for novel technologies.
Expanded reliance and recognition routes with trusted regulators, including the FDA, and continued recognition of CE-marked devices.
Limited fee vouchers for UK SMEs, subject to approval.
A modern AIaMD framework: continuous monitoring of real-world performance, with clear accountability across developers, deployers and health system partners.
Expanded Predetermined Change Control Plans, "enabling pre-agreed model updates to be implemented without unnecessary delay".
Explore Master Files so foundation model providers can share safety and performance information for AI-enabled devices built on them.
Establish a Centre for AI and Digital Health bringing together specialist expertise to give developers consistent expectations across the product lifecycle.
As a founding "pioneer" of the Health AI Global Regulatory Network, share safety signals and real-world performance data internationally; strengthen the IMDRF role and join MDSAP.
International partnerships: work globally to deliver locally, so submissions can be "prepared once and used across multiple trusted jurisdictions". Regulators increasingly shape global supply chains and market access. The MHRA aims for convergence with main partners and divergence only where there is a clear purpose. India alone supplies about 25% of UK medicines and a third of generics.
Key commitments:
Chair the Access Consortium (Australia, Canada, Switzerland, Singapore, UK) in 2026 and IMDRF in 2029; strengthen roles in ICH, ICMRA and PIC/S; join MDSAP.
Deepen FDA collaboration under the UK–US Economic Prosperity Deal and the US–UK pharmaceutical partnership, including the MHRA–FDA Pioneer Programme with liaison staff in each agency and greater mutual recognition of device approvals.
Continue EMA collaboration, including the Windsor Framework, and explore greater EU equivalence where it helps patient access.
Build on WHO Listed Authority and Collaborating Centre status; the MHRA develops more than 90% of WHO international standards for biological medicines.
Priority markets: India (manufacturing standards, trials, innovation pathways), China (closer engagement, risk-assessed use of non-OECD data) and MENA (including AI-enabled healthcare).
Scale grant-funded capacity building with the Gates Foundation, CEPI and the African Medicines Agency; launch an annual regulatory science conference.
To learn more about techUK's work in collaboration to the MHRA, please reach out to our team at viola.pastorino@techUK.org
