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Last Updated on 20/10/2026 by Sarah Sarsby
Plans to reduce duplication in medical device regulation, improve product traceability, and provide targeted support for SMEs are among the commitments most relevant to BHTA members in the MHRA’s newly published 2030 strategy.
The ‘MHRA Strategy 2030’ sets out how the Medicines and Healthcare products Regulatory Agency intends to modernise regulation while strengthening patient safety. For members manufacturing, importing, or distributing medical devices, key points include changes to routes to market, proposed data requirements, and access to regulatory support.
MHRA Chief Executive Lawrence Tallon said: “Our 2030 Strategy sets out how, working with our partners across health and life sciences, we will translate scientific and technological innovation into better health outcomes for people across all four nations of the UK.”
Several measures remain proposals or depend on parliamentary approval; the strategy does not, by itself, introduce these changes.
Following its 2026 consultation, the MHRA is considering indefinite recognition in Great Britain of devices compliant with the EU Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation.
For members sourcing devices from the EU or supplying both British and EU markets, this could reduce duplicated regulatory work and support continuity of supply. However, indefinite recognition remains under consideration; the strategy does not confirm that all CE-marked devices will be recognised indefinitely.
The MHRA also plans to explore mutual recognition of medical devices with the US Food and Drug Administration and join the Medical Device Single Audit Program. This programme allows a single audit of a manufacturer’s quality management system to address the requirements of participating regulatory authorities, potentially reducing repeated audits for businesses operating internationally.
The strategy places greater emphasis on monitoring device performance and managing risks once products are in use.
Subject to the parliamentary process, proposed regulations would require unique device identifiers (UDIs), or an equivalent system, for most devices. The strategy specifies exceptions for non-implantable custom-made devices and non-implantable investigational devices.
The purpose is to enable precise identification and traceability throughout a device’s lifecycle. For manufacturers and suppliers, consistent identifiers could make it easier to link product records with reported safety concerns and identify affected devices. Depending on the final requirements, members may need to adapt how identifiers are recorded and shared across the supply chain.
The MHRA also plans to upgrade or replace systems for device registration, reporting, and public access to information. These changes are intended to improve data quality and transparency, giving businesses and healthcare organisations access to more reliable device information.
Greater use of health data, AI-enabled analysis, and targeted market surveillance will support earlier identification of potential risks. Improvements to Yellow Card reporting, including a more conversational interface from 2027, are intended to make reporting concerns easier for patients and healthcare professionals.
The MHRA plans targeted vouchers to help UK start-ups access premium regulatory services at lower cost. Its medical device commitments also include limited fee vouchers for UK SMEs, subject to approval.
For eligible BHTA members, this could make specialist advice more accessible. The strategy does not specify voucher values, discount levels, or detailed eligibility criteria.
The agency also intends to broaden scientific advice, including lighter-touch options for focused questions, and introduce formal Scientific Opinions providing a documented MHRA view on specific regulatory issues. These services are intended to help businesses make development decisions with greater confidence.
Subject to parliamentary approval, proposed new powers would allow the MHRA to undertake regulatory assessments directly. The strategy notes that these assessments can currently only be undertaken by Approved Bodies.
For manufacturers, this could provide an additional assessment route through the MHRA. However, the strategy does not establish that all devices could use this route or that Approved Bodies would cease to be needed. It highlights innovative technologies, including AI-enabled devices, advanced diagnostics, robotics, and novel implants.
The strategy also carries forward plans for an Early Access Service for Devices, first outlined in 2025. This would provide time-limited, conditional access for innovative devices addressing unmet clinical needs ahead of full regulatory assessment. For members developing eligible products, it would offer an opportunity to gather evidence in real-world settings while progressing towards full regulatory approval.
The MHRA plans closer coordination with national partners, including the National Institute for Health and Care Excellence (NICE), the NHS, and the Office for Life Sciences (OLS), to better connect regulation, research, assessment, and adoption.
Members developing digital or AI-enabled medical devices should note plans for an MHRA Centre for AI and Digital Health, intended to provide clearer and more consistent regulatory expectations.
The strategy envisages continuous monitoring of real-world performance, staged authorisation, and expanded Predetermined Change Control Plans. These plans would support the management of anticipated changes to AI-enabled devices, reflecting the challenges of regulating technologies whose performance can evolve over time.
The MHRA intends to strengthen patients’ contributions to regulatory decisions and publish a refreshed Patient and Public Involvement and Engagement Plan.
For assistive technology businesses, this is relevant to how users’ experiences and priorities inform the assessment of products. Greater patient involvement could help regulatory decisions reflect the outcomes that matter to people using devices in everyday life.
Read the full strategy and the MHRA’s guidance on what it means for medtech and the life sciences industry.
