On 11 May 2026, the Medicines and Healthcare products Regulatory Agency (“MHRA”) opened a call for evidence on proposed changes to pre-market medical device and in vitro diagnostic medical device (“IVD”) requirements in Great Britain (“GB”) under the Medical Device
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EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections for Life Sciences Companies
On 7 May 2026, the European Parliament and Council announced a provisional political agreement on the AI Act portion of the Digital Omnibus package. According to the European Parliament’s press release and the Council’s press release, the agreement aims…
The Law Commission of England & Wales announces a review of a potential new class actions regime
Background
On 20 April 2026, the Law Commission, an independent organisation established to keep the law of England and Wales under review and recommend reform, announced a new project to consider the potential introduction of a consumer class actions regime…
EU implements new rules on uniform procedural requirements for Notified Body assessments
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…
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…