The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance to help people safely choose and use mental health apps and digital technologies, amid the growing use of digital tools to support wellbeing and mental health care. The guidance is intended for anyone who uses digital mental health technologies (DMHTs), as well as parents and carers, and professionals who may recommend or support their use, including teachers, nurses, GPs and mental health practitioners. The guidance was developed in partnership with NHS England’s MindEd Technology Enhanced Learning (TEL) programme and forms part of an ongoing project supported by the Wellcome Trust, aimed at promoting the safe and effective use of DMHTs and strengthening the regulatory framework governing them. The MHRA highlights that some DMHTs are classified as medical devices, including those that claim to diagnose, treat or manage a mental‑health condition. In such cases, products must meet relevant safety standards and display a Conformité Européene (CE) or UK Conformity Assessed (UKCA) mark and users can verify whether a product is registered via the MHRA’s online public register, which provides additional reassurance that the product meets UK safety standards and is monitored once in use. However, MHRA notes that not all DMHTs fall within medical device regulation. Some are instead categorised as wellbeing or lifestyle products, which does not mean they are unsafe, but that they may not have undergone the same regulatory checks as medical devices. It adds that if a regulated DMHT causes harm or distress, concerns can be reported through the Yellow Card scheme.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on 16 April 2025 detailing requirements for risk minimisation measures for medicines. The guidance outlines how Marketing Authorisation Holders must implement both routine and additional risk minimisation measures, including patient guidance, controlled access programmes, and pregnancy prevention programmes. It explains MHRA's decision-making process for requiring additional measures and specifies that all materials must be MHRA-approved before distribution. The guidance aims to ensure safe medicine use through clear protocols for healthcare professionals and patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Statement of Policy Intent outlining plans to establish an Early Access service for innovative medical devices. The service will provide time-limited, conditional access to promising technologies ahead of full regulatory approval where clinical need and evidence of patient benefit exist. Initial focus will be on innovative diagnostic devices addressing urgent NHS needs. The Early Access service will build on experience from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP). This forms part of MHRA's contribution to the UK Government's Life Sciences Sector Plan and 10-Year Health Plan.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a statement and proposed framework on the draft policy for recognition by the UK of international regulators’ approvals of medical devices, which would apply to medical devices in Great Britain. The proposed framework would provide a certificate of international recognition that will grant devices access to the Great Britain market but would not provide a UKCA marking or UKCA certification. The statement includes proposed access routes. This proposed draft framework is expected to come into force in 2025, and MHRA is testing the proposed framework with a range of devices across all classifications to establish the process and associated guidance.

Life Sciences analysis: On 31 July 2025, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (Early Access Service). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval—in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025). Sarah Cowlishaw & Dan Spivey of Covington & Burling LLP consider the issues at hand.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a statement confirming that it has raised concerns about the safety and wellbeing of participants in the PATHWAYS clinical trial of puberty-suppressing hormones and has initiated a scientific dialogue with the trial’s sponsor, King's College London.  In response, the Department of Health and Social Care announced that the Clinical Trial of an Investigational Medicine Product (CTIMP) has been paused. MHRA’s concerns relate to the implementation of minimum age restrictions, safety monitoring procedures and withdrawal criteria. MHRA has written to the trial sponsor outlining these issues and a scientific dialogue will now take place. Meanwhile, the Health Research Authority (HRA) confirmed that it will review the study in accordance with its standard operating procedures before the trial can resume. The HRA is working closely with the MHRA to address and manage the concerns raised about the trial.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the selection of five innovative AI technologies for its AI Airlock pilot scheme. This regulatory sandbox aims to test and improve rules for AI-powered medical devices, facilitating quicker and safer access to these technologies for the NHS and patients. The pilot, set to conclude in 2025, will inform future UK AI Medical Device guidance and addresses the need for robust regulatory frameworks highlighted in Lord Darzi's recent report on AI in healthcare. Selected technologies focus on areas including COPD risk prediction, radiology reporting efficiency, AI performance monitoring, cancer care management, and clinical decision support.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox to test artificial intelligence (AI) tools for medicines development and safety assessment, as well as the prediction of potential side effects. Funded by the Regulatory Innovation Office, the sandbox will provide a controlled testing environment in which companies and researchers can work with regulators to explore AI tools capable of predicting how medicines behave, including how they are absorbed, processed and whether they may cause harm. The programme will also consider how better use of clinical data could improve understanding of how medicines work across underrepresented patient groups, including children, older people and those from diverse backgrounds. Up to five AI-driven approaches will be tested in the first phase. The MHRA will begin working with industry and academic partners from summer 2026 to shape how the sandbox operates. It will use this work to assess the reliability of these tools and whether they could support decisions on the safety of new medicines.

The MHRA has launched a consultation on adopting International Council for Harmonisation (ICH) guideline Q3E for Extractables and Leachables. The guideline draws from the principles of risk management in ICH Q9 to establish a holistic framework for the assessment and control of leachable impuritie. Leachables are chemical entities that migrate from manufacturing components/systems, packaging or delivery device components into a drug product under the established manufacturing and labelled storage conditions. Extractables are chemical entities that are intentionally extracted from manufacturing components/systems, packaging or delivery device components under specified laboratory test conditions and thus are potential leachables. The draft guideline expands the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7) to assist in future-proofing these principles as rapid advances continue for therapeutic modalities.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched its 2024–2025 business plan, extending its three-year corporate plan initiated in 2023 to account for work done and upcoming aims. The plan is centred on four strategic priorities, namely maintaining public trust, enabling access to safe and effective medical products, delivering scientific and regulatory excellence through strategic partnerships, and becoming an agency where people flourish alongside a responsive customer service culture. Notably, under the third priority to improve MHRA's regulatory science and data strategies, it announced that it will establish a network of Centres of Excellence in Regulatory Science and Innovation across all priority areas by the end of Q4 2025. Additionally, the MHRA aims to enhance workplace diversity and inclusivity while implementing two new regulatory IT systems to bolster UK life sciences.

The Medicines and Healthcare (MHRA) products Regulatory Agency has launched an open call for evidence to inform the work of the National Commission into the Regulation of AI in Healthcare, seeking views on how artificial intelligence used in healthcare should be regulated in the UK. The MHRA established the Commission to advise on the development of a regulatory framework for AI as a medical device that is safe, effective, proportionate and trusted, with recommendations to be published in 2026. It seeks views on whether the current regulatory framework is sufficient, how it may need to be improved to support timely access to safe and effective AI medical devices, how safety and performance should be monitored once such technologies are in use, and how responsibility and liability should be allocated across those involved in their development and deployment, in order to address emerging regulatory challenges while supporting innovation and maintaining public trust . The call for evidence will run until 2 February 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation seeking views on proposed amendments to introduce common specification requirements for manufacturers of high-risk in vitro diagnostic (IVD) devices to the Medical Devices Regulations 2002. Additionally, the MHRA is seeking views on removing the Coronavirus Test Device Approval process. The deadline for response is 14 June 2024.