Medical Devices

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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 management of virtually all packaging placed on the EU market. Some in the life sciences field may assume that medical device, IVD and pharmaceutical packaging sits outside general packaging rules. That assumption is misguided: the PPWR applies broadly, and the sector-specific exemptions it contains are narrow and conditional.

Non-compliance is not a minor administrative matter. Packaging that does not meet PPWR requirements cannot lawfully be placed on the EU market, and life sciences companies that fail to act risk losing EU market access for their products, regardless of whether those products themselves hold valid CE Certificates of Conformity under the MDR, IVDR or marketing authorisation under applicable pharmaceutical legislation.

Continue Reading The EU Packaging and Packaging Waste Regulation: Why Life Sciences Companies Should Act Now

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 2026 saw continued momentum across the European Union (EU) and United Kingdom (UK) toward modernizing and streamlining the regulatory landscape for digital health, with a particular focus on accommodating AI-enabled technologies while reducing unnecessary complexity. A central development was the provisional agreement on the Digital Omnibus package, which seeks to simplify the application of the EU AI Act by clarifying overlaps with sector-specific legislation, deferring key obligations, and introducing more proportionate requirements.

In parallel, regulators on both sides of the Channel are advancing reforms to ensure that medical device frameworks remain fit for purpose in an increasingly software-driven and data-centric environment. In the EU, the activation of key European Database on Medical Devices (EUDAMED) modules marks a major step toward enhanced transparency and traceability, while ongoing discussions on the Medical Devices Regulation 2017/745 (MDR)/In Vitro Diagnostic Regulation 2017/746 (IVDR) revisions highlight a strong policy drive toward simplification and better integration of AI. In the UK, the Medicines and Healthcare products Regulatory Agency’s (MHRA) proposed pre-market reforms and broader thinking on AI regulation signal a shift toward more flexible, lifecycle-based oversight, with greater emphasis on post-market monitoring and innovation support.

Data governance and cybersecurity also remain high on the agenda. Industry and regulators alike are emphasizing the need for coherent, proportionate frameworks that avoid duplication while enabling innovation, particularly in light of expanding AI use cases and global supply chains. Together, these developments reflect a broader trend toward risk-based, innovation-friendly regulation, coupled with increasing expectations around transparency, accountability, and data protection in digital health.

Continue Reading Virtual and Digital Health Digest – June 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 level policy ambition to the practical mechanics of enabling AI driven health care, with particular emphasis on health data governance, regulatory pilots, and institutional readiness.

At the EU level, attention is increasingly focused on building durable frameworks to support innovation while maintaining regulatory confidence. The European Medicines Agency is preparing to pilot enhanced regulatory support for breakthrough medical devices and in vitro diagnostics (IVD), an initiative expected to shape future reforms of the EU medical device and IVD regimes. In parallel, the European Commission has taken further steps to operationalize the European Health Data Space (EHDS) through new implementing rules on the governance of the European Health Data Space Board, signaling a move from legislation to execution. The European Data Protection Board (EDPB) has also issued draft guidelines on the application of the General Data Protection Regulation (GDPR) to scientific research, offering long awaited clarification on lawful bases, consent models, and secondary use of data, issues that are central to data intensive research and AI development and likely to influence practice across Member States once finalized.

In the UK, scrutiny has centered on whether existing data and regulatory structures are capable of supporting personalized medicine and AI at scale. Evidence to the House of Lords Science and Technology Committee highlighted the UK’s rich but underexploited health data assets and the persistence of access barriers since the pandemic, with witnesses pointing to fragmented governance and delays in data access as ongoing constraints. At the same time, the expansion of the Medicines and Healthcare products Regulatory Agency’s (MHRA) AI Airlock program, continued work by the National AI Commission, and targeted support for AI driven drug discovery reflect a more iterative, test and learn approach to AI regulation, focused on post market oversight rather than wholesale reform.

Continue Reading Virtual and Digital Health Digest – May 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 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

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 Devices (Amendment) Regulations 2026 (“Amending Regulations”). This call for evidence forms a critical part of the UK government’s process for assessing the real‑world implications of a major reform of GB’s medical devices regulatory framework.

These long awaited proposals, as referred to in the MHRA Roadmap published in December 2024, follow previous amendments made to the 2002 Regulations in June 2025, relating to post-market surveillance. Read about these amendments in our previous blog.

Below, we explain what the call for evidence is, why it matters, and provide an overview of some of the key regulatory proposals that stakeholders are being asked to comment on.

Continue Reading Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence

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 text has not yet been published, and the agreement remains provisional pending formal adoption by both institutions, which co-legislators intend to complete before 2 August 2026, the date on which the AI Act’s original high-risk system obligations were due to become applicable.

This blog post sets out what the press release describes as having been agreed, and flags the points most relevant to pharmaceutical and MedTech companies. As we noted in our earlier analysis, the Digital Omnibus on AI Proposal carries significant implications for life sciences companies. We will provide a fuller assessment once the agreed text is available and adopted.

Continue Reading EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections for Life Sciences Companies

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, they may be bespoke assays created specifically for use in a given clinical trial or in connection with an investigational medicinal product (IMP).

Continue Reading Navigating IVD Regulation in Clinical Trials: A Comparative EU and UK Guide

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

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 ongoing efforts to refine its post‑Brexit regulatory landscape and ensure continued patient access to safe, effective medical technologies. The consultation invites feedback from a broad range of stakeholders, including manufacturers, distributors, clinicians, procurement bodies, trade associations, regulatory specialists, and patient organisations. It follows the UK government’s response in July 2025 to its consultation on routes to market for medical devices and IVDs, which outlined, among other initiatives, details of a future international reliance scheme – see our previous blog post on this for more information.

Continue Reading MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical Devices

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