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
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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
Virtual and Digital Health Digest – May 2026
Regulatory activity in the EU and UK over the past month has focused on AI in health care, health data access, and digital innovation frameworks. Recent regulatory developments in the EU and UK point to a decisive shift from high
UK MHRA consults on a new regulatory framework for rare disease therapies
The MHRA’s proposed rare disease therapies regulatory framework (“the Proposed Framework”) represents an ambitious attempt to redesign medicines regulation around the realities of rare disease development.
On 21 May 2026, the MHRA launched its consultation on the Proposed Framework, representing
Virtual and Digital Health Digest – April 2026
Regulatory activity in the EU and UK over the past month has focused on accelerating the alignment of digital, AI, and life sciences regulatory frameworks, alongside increasing scrutiny of data governance and market readiness for emerging technologies. At the EU
MHRA launches consultation on modernising the definition of gene therapy medicinal products
The MHRA has launched a consultation on proposed updates to the definition of gene therapy medicinal products (“GTMPs”) under the UK Human Medicines Regulations 2012 (“HMRs”). The current definition was originally developed in 2007, and was based on a smaller