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January 2026 saw significant activity as UK and EU authorities advanced major initiatives affecting the use of AI, digital technologies, data governance, and cybersecurity in healthcare and life sciences. Notable developments include EMA’s and FDA joint principles on the use of AI across the medicinal product lifecycle, the European Commission’s call for evidence on the proposed amendments to the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), proposals to strengthen the EU Cybersecurity Act, and important data protection interventions. In parallel, UK and EU regulators continued to focus on the safe deployment of digital tools in healthcare, including new Medicines and Healthcare products Regulatory Agency (MHRA) guidance on mental health technologies and ongoing work to refine AI governance. These updates, alongside developments in Intellectual Property (IP) and product liability, signal a rapidly evolving regulatory environment that will help to shape digital innovation and compliance expectations throughout 2026.Continue Reading Virtual and Digital Health Digest – February 2026

Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s ongoing efforts to refine its post‑Brexit regulatory landscape and ensure continued patient access to safe, effective medical technologies. The consultation invites feedback from a broad range of stakeholders, including manufacturers, distributors, clinicians, procurement bodies, trade associations, regulatory specialists, and patient organisations. It follows the UK government’s response in July 2025 to its consultation on routes to market for medical devices and IVDs, which outlined, among other initiatives, details of a future international reliance scheme – see our previous blog post on this for more information.Continue Reading MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical Devices

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – December 2025

Growth in UK clinical trials

The UK’s ambition to strengthen its position as a leading destination for global clinical research is beginning to show results. According to a recent MHRA publication, clinical trial applications submitted between January and November 2025 were 9% higher than during the same period in 2024, with particularly notable increases in:

  • Trials in healthy volunteers (+16%)
  • First‑in‑human studies (+5%)
  • Trials being run in the UK for the first time (+7%)

The publication notes that “growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.”Continue Reading UK Clinical Trials Reform: Early Growth Indicators and Key MHRA Guidance

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – November 2025

A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.Continue Reading MHRA and NICE launch aligned approvals pathway

On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.  It is hoped this will lead to quick market access of such devices, by addressing challenges associated with generating sufficient evidence to obtain regulatory approval.Continue Reading UK proposes Early Access Service for innovative medical devices

The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the UK. Changes are aimed at closer alignment with international best practice and to ensure that Great Britain has risk proportionate regulations. Changes are not intended to introduce the EU Medical Devices Regulations into UK law, although there are of course similarities, which has been welcomed by those responding to the consultation.

There were four key areas under consultation: (1) International reliance, (2) UKCA marking, (3) IVD devices, and (4) Assimilated EU law. We have set out a summary on each of these below.Continue Reading UK Medical Devices Regulations: further changes afoot

On 16 June 2025, the UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force, marking the first step in the reform of the UK legislation for medical devices. The regulations apply to Great Britain (England, Wales and Scotland), and medical devices placed on the market in Northern Ireland must follow…