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The MHRA’s proposed rare disease therapies regulatory framework (“the Proposed Framework”) represents an ambitious attempt to redesign medicines regulation around the realities of rare disease development.

On 21 May 2026, the MHRA launched its consultation on the Proposed Framework, representing a significant step in the UK’s ambition to become a global leader in the development of therapies for rare diseases.

The initiative reflects the scale of unmet need: around 1 in 17 people will be affected by a rare disease during their lifetime, equating to over 3.5 million people in the UK, yet only around 5% of rare diseases have an approved treatment.

The consultation acknowledges that traditional regulatory approaches, designed for common diseases with large patient populations and well‑established trial paradigms, are often unsuitable for rare disease therapies.  Against this backdrop, the Proposed Framework aims to enable earlier patient access to promising therapies, reduce development burden, and incentivise innovation, while maintaining the UK’s standards of safety, quality and efficacy.

The MHRA requests responses from industry, patient organisations and other stakeholders. The consultation closes on 30 July 2026.

… Continue Reading UK MHRA consults on a new regulatory framework for rare disease therapies

Regulatory activity in the EU and UK over the past month has focused on accelerating the alignment of digital, AI, and life sciences regulatory frameworks, alongside increasing scrutiny of data governance and market readiness for emerging technologies. At the EU level, work to simplify and streamline EU AI-related legislation has advanced, with the Council of the European Union and European Parliament having adopted their positions on the European Commission’s (EC) Digital Omnibus reforms, and now entering trilogue negotiations on the final text. In parallel, MedTech Europe published its response to the EC consultation on the simplification of the EU AI rules as part of the Digital Omnibus, calling for clearer integration between the AI Act and other sectoral legislation, as well as extended implementation timelines. Separately, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed European Biotech Act, emphasizing the need for clearer safeguards, harmonized legal bases for processing clinical data, and strong protections when health and genetic data are used in biotech and AI contexts. In the UK, developments have focused on the role of AI-enabled innovation within the health care system. A new parliamentary inquiry into personalized medicine and AI will examine ongoing challenges and barriers to National Health Service (NHS) adoption of new technologies, including procurement, digital infrastructure limitations, and system fragmentation. At the same time, the Medicines and Healthcare products Regulatory Agency (MHRA) has secured multi year funding to expand its AI Airlock Program to support the development of more ambitious AI medical devices. These initiatives signal a continued policy commitment to embedding digital and AI driven innovation into health care delivery and to strengthening the regulatory environment required to support safe deployment at scale.…

Continue Reading Virtual and Digital Health Digest – April 2026

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