The BioSlice Blog, published by Arnold & Porter Kaye Scholer LLP, focuses on regulatory, legal, and policy developments in the life sciences sector. It covers topics such as medical device regulations, pharmaceutical legislation reforms, intellectual property frameworks in healthcare, and digital health innovations. The blog provides analysis on EU and UK regulatory changes, compliance challenges, and industry impacts, including discussions on breakthrough and orphan device pathways, notified body regulations, NHS IP guidance updates, and antimicrobial resistance measures. It also addresses litigation, transactional, and public policy issues relevant to biotech, medtech, and pharmaceutical companies operating in regulated markets.
On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.
For pharmaceutical, MedTech, and biotech companies,…
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,…
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.…
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…
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…
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…
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…
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…
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)…
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…
