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 a significant step in the UK’s ambition to become a global leader in the development…
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 level, work to simplify and streamline EU AI-related legislation has advanced, with the Council of…
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 range of technologies. It is no longer considered to reflect the full range of modern…
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 Regulations 2002 (“2002 Regulations”). The proposals are set out in the newly published draft Medical…
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 to make compliance more workable, while maintaining its main provisions and risk-based approach. The agreed…
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 in England and Wales. While independent, the Law Commission’s project is sponsored by the Department…
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 their interactions with Notified Bodies during the initial conformity assessment process and in post-market modifications…
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 In Vitro Diagnostic Regulation (IVDR) and/or the UK Medical Devices Regulations 2002 (UK MDR). Alternatively,…
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 Union.
February 2026 saw a period of substantial regulatory activity across both the UK and…
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 German optician’s newsletter and, thirteen days later, submitted an access request under Article 15 GDPR.…
