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 Holders

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 2025

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?

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 Manufacturing

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 EU

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 restrictive

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

On 21 May 2025, the European Parliament and Council reached a provisional agreement on a new Regulation which establishes an EU-level framework on compulsory licensing of patents for any crisis emergency-related products in the EU, including medicinal products. The draft legislation, published in 2023, must now be endorsed and formally adopted by both the Parliament and the Council, expected in the coming months.

Continue Reading One step closer to EU-wide compulsory licences for crisis management

The recently published MDCG 2025-4 guidance provides important clarifications on how Medical Device Software (MDSW) apps should be made available via online platforms and on the role of these online platforms. With digital distribution channels such as the App Store and Google Play playing a central role in healthcare software deployment, the guidance has significant implications for medical device manufacturers operating in the EU.

In essence, the guidance clarifies that digital distribution does not reduce regulatory obligations. Software-based medical devices must be subject to the same level of regulatory scrutiny and compliance as traditional, physical devices.

We set out below some comments on the distinction between platforms acting as intermediary service providers under the Digital Services Act (DSA) and those that may qualify as importers or distributors under the EU Medical Devices Regulations (the MDR and IVDR).

Continue Reading EU Medical Device Software: New guidance on placing software medical devices on the EU market

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 devices