EU Legislation

Subscribe to EU Legislation via RSS

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 European Union and European Parliament having adopted their positions on the European Commission’s (EC) Digital Omnibus reforms, and now entering trilogue negotiations on the final text. In parallel, MedTech Europe published its response to the EC consultation on the simplification of the EU AI rules as part of the Digital Omnibus, calling for clearer integration between the AI Act and other sectoral legislation, as well as extended implementation timelines. Separately, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed European Biotech Act, emphasizing the need for clearer safeguards, harmonized legal bases for processing clinical data, and strong protections when health and genetic data are used in biotech and AI contexts. In the UK, developments have focused on the role of AI-enabled innovation within the health care system. A new parliamentary inquiry into personalized medicine and AI will examine ongoing challenges and barriers to National Health Service (NHS) adoption of new technologies, including procurement, digital infrastructure limitations, and system fragmentation. At the same time, the Medicines and Healthcare products Regulatory Agency (MHRA) has secured multi year funding to expand its AI Airlock Program to support the development of more ambitious AI medical devices. These initiatives signal a continued policy commitment to embedding digital and AI driven innovation into health care delivery and to strengthening the regulatory environment required to support safe deployment at scale.…

Continue Reading Virtual and Digital Health Digest – April 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 Union.

February 2026 saw a period of substantial regulatory activity across both the UK and EU, particularly in relation to AI governance, medical technologies, and data protection. In the UK, the policy landscape continued to evolve with initiatives affecting the regulation of medical devices, clinical research, and AI deployment. Key developments included the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on the indefinite recognition of CE-marked medical devices, record levels of medical device testing, and the Prescription Medicines Code of Practice Authority’s (PMCPA) revised guidance on the use of social media. AI remained a major focus in the UK, with the UK government’s response to the consultation on the AI Management Essentials tool, increased industry involvement in the UK AI Security Institute’s alignment program, and feedback relating to governmental research on AI adoption across UK businesses. Additional international collaboration efforts included UK engagement at the India AI Impact Summit and an expanded science and technology partnership with Japan, as well as the launch of the first-ever AI Strategy for UK Research and Innovation.

Continue Reading Virtual and Digital Health Digest – February 2026

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 Proposal is ambitious in scope: it amends several major pieces of EU health legislation, including the Clinical Trials Regulation (“CTR”), the Veterinary Medicines Regulation, the Food Law Regulation and the Substances of Human Origin Regulation (“SoHO”), while also introducing a new framework for EU strategic projects, AI-enabled biotechnology, and biodefence.

On 10 March 2026, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) adopted Joint Opinion 3/2026 on the Proposal (the “Joint Opinion”). While broadly supportive of the Proposal’s objectives, the EDPB and EDPS identified a number of significant data protection concerns, and issued recommendations. Although not legally binding, the Joint Opinion carries significant weight as it reflects the views of the EU’s primary data protection authorities and will directly shape the legislative debate ahead.

In this blog we examine the key data protection implications of the Proposal and the Joint Opinion for pharma and life sciences companies.

Continue Reading EDPB/EDPS Joint Opinion on the European Biotech Act Proposal: Key Data Protection Implications for Pharma and Life Sciences

Today, 6 March 2026, the Council of the European Union (“Council”) published the provisional agreement on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European Parliament and the Council is expected in the coming months. 

Continue Reading Provisional text of the political agreement on the reform to the EU Regulatory Framework for Medicinal Products is published

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 European Union.

January 2026 saw significant activity as UK and EU authorities advanced major initiatives affecting the use of AI, digital technologies, data governance, and cybersecurity in healthcare and life sciences. Notable developments include EMA’s and FDA joint principles on the use of AI across the medicinal product lifecycle, the European Commission’s call for evidence on the proposed amendments to the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), proposals to strengthen the EU Cybersecurity Act, and important data protection interventions. In parallel, UK and EU regulators continued to focus on the safe deployment of digital tools in healthcare, including new Medicines and Healthcare products Regulatory Agency (MHRA) guidance on mental health technologies and ongoing work to refine AI governance. These updates, alongside developments in Intellectual Property (IP) and product liability, signal a rapidly evolving regulatory environment that will help to shape digital innovation and compliance expectations throughout 2026.

Continue Reading Virtual and Digital Health Digest – January 2026

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 digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range of instruments, including the EU AI Act (Regulation (EU) 2024/1689), the GDPR (Regulation (EU) 2016/679), the ePrivacy Directive (2002/58/EC), the NIS2 Directive ((EU) 2022/2555), and the EU Data Act (Regulation (EU) 2023/2854).

Continue Reading EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech

Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.

Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare For

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 European Union.

Continue Reading Virtual and Digital Health Digest – December 2025

On 12 December 2025, the European Commission published a draft Implementing Regulation (“the Regulation”) on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies (“NBs”), introducing detailed requirements for NBs operating under the Medical Device Regulations (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (“IVDR”).

The recitals describe serious systemic challenges that have emerged since the implementation of the MDR/IVDR and the proposals aim to set out a structured resolution to these challenges. An overview of these proposals is set out below. Overall, the Regulation aims to create a harmonised NB landscape that is predictable, transparent, and fair – supporting patient safety while easing unnecessary administrative burdens for manufacturers. Whether this goes far enough to address the challenges identified will have to be seen.

The Regulation is open for public consultation until 23 January 2026. Once feedback has been reviewed by the Commission, it will be published. The Commission  anticipates adoption of the Regulations in the first quarter of 2026, following which it will be sent to the European Parliament and Council for consideration. The timing of the formal adoption of the Regulation is not yet clear.

Continue Reading A Deep Dive into the EU’s New Implementing Regulation for Notified Bodies