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 devicesIs change on the horizon for the UK product liability regime? [Updated]
By Libby Amos-Stone on
The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.
Continue Reading Is change on the horizon for the UK product liability regime? [Updated]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 afootUpdates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders
On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 (“Regulation”), updating the EU pharmacovigilance (or “PV”) rules by way of amendments to Implementing Regulation (EU) No 520/2012. The changes aim to clarify and strengthen certain pharmacovigilance obligations (some of which arguably reflect what is already the current practice and expectations of the EU PV inspectors).
The Regulation introduces a number of new compliance expectations and requirements for applicants and marketing authorisation holders (“MAHs”), some of which will start to apply before mid-August.
Continue Reading Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation HoldersVirtual 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 2025The UK Government has plans: what does this mean for the Life Sciences Sector?
By Arnold & Porter, Katya Farkas & Heba Jalil on
The UK Government has recently published plans for the Life Sciences Sector and the NHS in England. In this blog post, we summarise these plans and some of the initial feedback that has been published by ABPI. It is not surprising that there is a large amount of overlap between the two plans, albeit that the NHS 10 Year Plan is more rooted in the public sector. Both plans send a clear message: the Government recognises the vital role that life sciences companies must play in order to improve the UK’s standing as a centre for life sciences. The impact these plans will have on the Life Sciences industry, and whether they are enough to realise the Government’s ambitions, remains to be determined.
Continue Reading The UK Government has plans: what does this mean for the Life Sciences Sector?EU Consults on New GMP Rules for AI in Pharma Manufacturing
By Alexander Roussanov & Anna Pothof on
On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing Practice (GMP) guidelines—specifically Chapter 4 on Documentation, Annex 11 on Computerised Systems, and, for the first time, a new Annex 22 dedicated to AI.
Continue Reading EU Consults on New GMP Rules for AI in Pharma ManufacturingRevised 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 EUThe European Court of Justice rules that Poland’s laws prohibiting pharmacies from advertising are overly restrictive
By Libby Amos-Stone & Katya Farkas on
The European Court of Justice (the “Court”) has ruled that Poland’s law prohibiting advertising by pharmacies and pharmaceutical outlets is overly restrictive and contrary to EU law.
The Polish legislation (Article 94a(1) of the Law on Medicines, as amended) which had been in force since 2012, prohibits pharmacies and pharmaceutical outlets from engaging in any form of advertising or promotional activity other than providing limited information on their location and opening hours. Any person who is found to be in breach of the provisions is liable to a fine of up to 50,000 Polish zloty (PLN) (approximately EUR 12,000).
Continue Reading The European Court of Justice rules that Poland’s laws prohibiting pharmacies from advertising are overly restrictiveVirtual 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 2025