On 30 June 2026, the UK government introduced the Immigration and Asylum Bill (the Bill), proposing the most significant reforms to the Modern Slavery Act 2015 (the MSA) since its enactment. The MSA’s transparency-in-supply-chains regime relies on voluntary disclosure is
BioSlice Blog
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.
AG Kokott recommends annulment of Urban Wastewater Directive’s pharmaceutical and cosmetics levy
On 3 September 2026, Advocate General Kokott delivered a significant Opinion in Case C‑193/25, Poland v Parliament and Council, recommending the annulment of the provisions of the revised Urban Waste Water Treatment Directive 2024/3019 (UWWTD) that require pharmaceutical and cosmetics…
CJEU ruling clarifies scope of medical device definition
The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising…
Virtual and Digital Health Digest – August 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 July and early August 2026 from the EU and UK.
During July 2026,…
How will the EU Parliament shape the MDR/IVDR revision? Draft report indicates how Parliament may seek to amend Commission’s proposals
On 1 July 2026, the Rapporteur in the European Parliament’s Committee on Public Health (SANT) published his draft report (the Draft Report) in response to the Commission’s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) (the…
The EU Data Act’s Access-by-Design Deadline: What Life Sciences Companies Need to Know Before September 2026
Since 12 September 2025, the EU Data Act (Regulation (EU) 2023/2854, the “EU Data Act”) has required manufacturers of connected products and providers of related services to make in-scope data accessible to users, whether through direct or indirect access mechanisms.…
Virtual and Digital Health Digest – July 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 June and early July 2026 from the United Kingdom and European Union.…
The EU Packaging and Packaging Waste Regulation: Why Life Sciences Companies Should Act Now
On 12 August 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) (the “PPWR”) becomes applicable. It replaces the long-standing Packaging and Packaging Waste Directive with a directly applicable, EU-wide regime governing the design, documentation, labelling and end-of-life…
EDPB Guidelines on Anonymisation: What Life Sciences Companies Need to Know
On 7 July 2026, the European Data Protection Board (“EDPB”) adopted its Guidelines 02/2026 on Anonymisation for public consultation (the “Guidelines”), replacing the Article 29 Working Party’s Opinion 05/2014 that served as one of the primary EU references on the…
Virtual and Digital Health Digest – June 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 May and early June 2026 from the United Kingdom and European Union.
May…