On 5 May 2026, the European Commission published an implementing regulation setting new procedural requirements for Notified Body assessments in medical device and IVD conformity assessment procedures (the “Implementing Regulation”). The Implementing Regulation aims to give manufacturers greater certainty in
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.
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Navigating IVD Regulation in Clinical Trials: A Comparative EU and UK Guide
By Fabien Roy & Eleri Abreo
Introduction
Assays used in clinical trials vary widely in complexity and regulatory status.. They may be fully developed and marketed as in vitro diagnostic medical devices (IVDs), including companion diagnostics (CDx), that clearly fall within the scope of the EU…
Virtual and Digital Health Digest – February 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 February and early March 2026 from the the United Kingdom, and European…
CJEU rules on GDPR access rights and abuse of rights: what the Brillen Rottler judgment means for life sciences companies
On 19 March 2026, the Court of Justice of the European Union (CJEU or Court) issued its judgment in Case C-526/24, Brillen Rottler GmbH & Co. KG v TC. The case concerned a data subject who subscribed to a…
EDPB/EDPS Joint Opinion on the European Biotech Act Proposal: Key Data Protection Implications for Pharma and Life Sciences
On 16 December 2025, the European Commission published its Proposal for a Regulation establishing a framework of measures for strengthening the EU’s biotechnology and biomanufacturing sectors, particularly in the area of health (the “European Biotech Act” or the “Proposal”). The…
Final text of the reform to the EU Regulatory Framework for Medicinal Products published
Virtual and Digital Health Digest – January 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 December 2025 and early January 2026 from the the United Kingdom, and…
EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s…
UK PMCPA publishes revised guidance for the use of social media
The Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.
Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the…
MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical Devices
Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s…