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 devicesMedical Devices
UK Medical Devices Regulations: further changes afoot
By Arnold & Porter & Eleri Abreo on
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 afootVirtual and Digital Health Digest – July 2025
By Arnold & Porter, James Castro-Edwards, Sofia Holmquist, Ana Gonzalez-Lamuno & Eleanor Brittain on
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 June and early July 2025 from the United Kingdom and European Union.
There has been a flurry of new guidance from the Medical Device Coordination Group this month, including guidance on classification of medical device software, on supply of software apps through online platform such as the App Store and Google Play, and on the interaction between the Medical Device Regulation and the EU AI Act. These are welcome guidance documents to provide important clarification for manufacturers as they develop software medical devices, although the guidance documents inevitably cannot cover every situation and leave some questions unanswered.
Continue Reading Virtual and Digital Health Digest – July 2025Revised guidance on classification of Medical Device Software in the EU
By Arnold & Porter & Eftychia Sideri on
The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance) introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance provides more detailed examples, specifically includes software using artificial intelligence (AI), and addresses modular software and interoperability with electronic health records (EHRs) under the European Health Data Space (EHDS).
This blog post outlines these key updates and considers their potential impact on compliance obligations for software manufacturers.
Continue Reading Revised guidance on classification of Medical Device Software in the EUVirtual and Digital Health Digest – June 2025
By Arnold & Porter, Dr Beatriz San Martin, Sofia Holmquist, Ana Gonzalez-Lamuno, Emma Elliston, Zahrah Kazim, George Zografos & Eleanor Brittain on
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 May and early June 2025 from the United Kingdom and European Union.
There has been a lot of focus on AI this month. The European Commission has launched a consultation on high-risk AI systems, which includes medical devices and is therefore highly relevant for digital health companies. The European Medicines Agency has published a workplan on data and AI use, which sets out how the European Medicines Regulatory Network plans to leverage large volumes of regulatory and health data to support regulatory decision-making for better medicines. There has also been international guidance published on the use of AI in pharmacovigilance. However, there has also been controversy as the UK Data Use and Access Bill continues through the parliamentary process, as there is disagreement on its treatment of copyright-protected material in the development of AI systems. As uses of AI continue and authorities seek to put in place relevant legislation and guidance to match the speed of development, expect this focus to continue.
Continue Reading Virtual and Digital Health Digest – June 2025European Commission launches COMBINE pilot to streamline approval of studies involving medicinal products and in vitro diagnostic medical devices
On 13 June 2025, the European Commission launched the first phase of a pilot project under its COMBINE programme (the pilot project), aiming to streamline the authorisation process for combined studies involving both clinical trials of medicinal products and performance studies of in vitro diagnostic medical devices (IVD) (referred to as combined studies below).
The pilot project represents a significant step towards addressing the complex and fragmented regulatory landscape that sponsors currently face when submitting applications for combined studies across multiple EU countries. Although its practical effectiveness remains to be seen, the pilot project represents a positive development that should facilitate the approval of combined studies in the EU.
The pilot project is the first initiative under the COMBINE programme, with additional projects planned to launch in the coming years.
Continue Reading European Commission launches COMBINE pilot to streamline approval of studies involving medicinal products and in vitro diagnostic medical devicesUK Regulations on Medical Device Post-Market Surveillance come into force
By Arnold & Porter on
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…
Virtual and Digital Health Digest – May 2025
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 April and early May 2025 from the United States, United Kingdom, and European Union.
Cybersecurity is a hot topic in the UK and EU this month. In both, cybersecurity plans are developing, with the European Commission conducting a consultation on the EU Action Plan to strengthen cybersecurity within hospitals and health care providers, and the UK Cyber Security and Resilience Bill being published, introduced partly because of cyberattacks on UK hospitals. This is clearly an important area for developers of digital products and services, who should watch the progress of these policies closely.
Continue Reading Virtual and Digital Health Digest – May 2025Virtual and Digital Health Digest – April 2025
By Arnold & Porter, Dr Beatriz San Martin, Ludovica Pizzetti, Emma Elliston, Ana Gonzalez-Lamuno, Heba Jalil, Zahrah Kazim & Joy Wee on
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 March and early April 2025 from the United States, United Kingdom, and European Union.
The biggest change this month is that as of March 25, 2025, the European Health Data Space Regulation (EHDS Regulation) is now in force. This means that, as it is gradually implemented, companies will be able to request access to electronic health data for health care purposes, including for use in scientific research, and may be required to share certain health data that they hold. The implementation of the EHDS Regulation is likely to raise a number of questions, which future European Commission implementing regulations or guidelines may clarify.
Continue Reading Virtual and Digital Health Digest – April 2025LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs
By Mahnu Davar & Philip Desjardins on
In our blog in December 2024, we provided an update on the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs). We noted that two cases had been filed challenging the…