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The MHRA has launched a consultation on proposed updates to the definition of gene therapy medicinal products (“GTMPs”) under the UK Human Medicines Regulations 2012 (“HMRs”). The current definition was originally developed in 2007, and was based on a smaller range of technologies. It is no longer considered to reflect the full range of modern gene therapy technologies now available, including therapies involving synthetic genetic material, new forms of genome editing, and highly engineered cells and tissues. This means there may not be a clear path to market for these technologies under the current legislation.

The proposals aim to address these limitations and align the regulatory framework with current scientific developments. The proposed reforms represent a targeted shift towards a more technology-neutral and mechanism-based approach. The proposals do not change the approval process, classification of existing products, or applicable safety and efficacy standards.

The MHRA is seeking input from stakeholders on whether the proposals are appropriate, proportionate and workable, including whether the revisions cover the correct categories of products, and whether these would cause any unintended consequences or operational challenges. The consultation is open until 22 June 2026 and feedback is requested in the form of a survey. Responses can be submitted online here.

Below, we outline the background, the key proposed changes, and the regulatory considerations that have shaped MHRA’s proposals.

Continue Reading MHRA launches consultation on modernising the definition of gene therapy medicinal products

On 11 May 2026, the Medicines and Healthcare products Regulatory Agency (“MHRA”) opened a call for evidence on proposed changes to pre-market medical device and in vitro diagnostic medical device (“IVD”) requirements in Great Britain (“GB”) under the Medical Device Regulations 2002 (“2002 Regulations”). The proposals are set out in the newly published draft Medical Devices (Amendment) Regulations 2026 (“Amending Regulations”). This call for evidence forms a critical part of the UK government’s process for assessing the real‑world implications of a major reform of GB’s medical devices regulatory framework.

These long awaited proposals, as referred to in the MHRA Roadmap published in December 2024, follow previous amendments made to the 2002 Regulations in June 2025, relating to post-market surveillance. Read about these amendments in our previous blog.

Below, we explain what the call for evidence is, why it matters, and provide an overview of some of the key regulatory proposals that stakeholders are being asked to comment on.

Continue Reading Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence

Introduction

Assays used in clinical trials vary widely in complexity and regulatory status.. They may be fully developed and marketed as in vitro diagnostic medical devices (IVDs), including companion diagnostics (CDx), that clearly fall within the scope of the EU In Vitro Diagnostic Regulation (IVDR) and/or the UK Medical Devices Regulations 2002 (UK MDR). Alternatively, they may be bespoke assays created specifically for use in a given clinical trial or in connection with an investigational medicinal product (IMP).

Continue Reading Navigating IVD Regulation in Clinical Trials: A Comparative EU and UK Guide

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 February and early March 2026 from the the United Kingdom, and European Union.

February 2026 saw a period of substantial regulatory activity across both the UK and EU, particularly in relation to AI governance, medical technologies, and data protection. In the UK, the policy landscape continued to evolve with initiatives affecting the regulation of medical devices, clinical research, and AI deployment. Key developments included the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on the indefinite recognition of CE-marked medical devices, record levels of medical device testing, and the Prescription Medicines Code of Practice Authority’s (PMCPA) revised guidance on the use of social media. AI remained a major focus in the UK, with the UK government’s response to the consultation on the AI Management Essentials tool, increased industry involvement in the UK AI Security Institute’s alignment program, and feedback relating to governmental research on AI adoption across UK businesses. Additional international collaboration efforts included UK engagement at the India AI Impact Summit and an expanded science and technology partnership with Japan, as well as the launch of the first-ever AI Strategy for UK Research and Innovation.

Continue Reading Virtual and Digital Health Digest – February 2026

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.

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 – January 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

Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.

Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare For

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

Introduction

The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and a call for evidence in September 2025 (see our blog here). The proposals respond to industry concerns over complexity, cost, and delays which have been substantially hammering the MedTech industry since the implementation of the MDR and IVDR.

The proposals aim to streamline regulatory processes, reduce administrative burden, and enhance predictability, while maintaining patient safety and public health. From adaptive pathways for breakthrough and orphan devices to leaner conformity assessments, stronger notified body (NB) governance, and changes to classification, these changes are designed to future-proof the regulatory framework and foster innovation. For manufacturers, healthcare institutions, innovators, and industry stakeholders, the proposals signal a shift toward a more proportionate, risk-based system that supports timely access to critical technologies without compromising quality.

Below, we have set out an overview of some of the key proposals.  Additionally, while not released with the proposals, the European Commission published a draft Implementing Regulation on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies – see our separate blog on this here.

The proposals have now been submitted to the European Parliament and Council for review. Once the Parliament and Council have adopted their own positions on the text, there will be negotiations to agree a final text which can be formally adopted by the Council and the Parliament. At this stage, it is challenging to anticipate what would be the result of the political negotiations and unclear when the new rules will start to apply.

A feedback period has been opened, running from 7 January to 5 March 2026. All feedback received will be summarised by the Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.

Continue Reading From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR