The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising of a product is not necessarily decisive in determining whether it has a “medical purpose” within the definition of “medical device” under the MDR, and that the product must also objectively perform one (or more) of those medical purposes to fall within that definition. The judgment also provides guidance on what constitutes a solely administrative function that does not fall within those medical purposes. The decision has the potential to guide other classification decisions of borderline products used in the healthcare sector.
Continue Reading CJEU ruling clarifies scope of medical device definitionMedical Devices
Virtual and Digital Health Digest – August 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 July and early August 2026 from the EU and UK.
During July 2026, regulators in the EU and UK continued to focus on the practical implementation of AI and digital health regulation.
In the EU, the Digital Omnibus on AI introduced the first substantive amendments to the AI Act, while policymakers and industry groups turned their attention to how AI requirements will interact with existing frameworks. This included new principles on the use of AI in Joint Clinical Assessment dossiers under the Health Technology Assessment Regulation, the European Federation of Pharmaceutical Industries and Association’s (EFPIA) call for trusted AI testing environments and proportionate AI governance in its response to the Biotech Act consultation, and further debate on the treatment of software and AI-enabled technologies in the ongoing Medical Device Regulation (MDR)/In Vitro Diagnostic Regulation (IVDR) revision. Together, these developments reflect a growing focus on ensuring that AI-specific requirements integrate effectively with existing regulatory frameworks.
In the UK, regulators published a series of guidance documents addressing questions about when AI-enabled products qualify as medical devices and how they should be regulated. New Medicines and Healthcare products Regulatory Agency (MHRA) guidance on ambient voice technologies and updated guidance on digital mental health technologies provide greater clarity on the medical device boundary, while additional outputs from the AI Airlock program highlight the challenges associated with qualification, intended purpose, and lifecycle management of AI systems. These developments suggest that regulators are increasingly focused on addressing practical implementation questions.
Continue Reading Virtual and Digital Health Digest – August 2026How will the EU Parliament shape the MDR/IVDR revision? Draft report indicates how Parliament may seek to amend Commission’s proposals
On 1 July 2026, the Rapporteur in the European Parliament’s Committee on Public Health (SANT) published his draft report (the Draft Report) in response to the Commission’s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) (the Commission Proposal). The details of the Commission Proposal are discussed in our December 2025 BioSlice blog post. The Draft Report contains over 130 suggested amendments to the Commission Proposal, giving an indication of what amendments the Parliament may target in the legislative process for the MDR/IVDR revision. The Report is therefore informative reading for industry on what amendments may ultimately be made to the MDR and IVDR.
The Draft Report, and the discussion of it in the SANT Committee, highlights that the Parliament is broadly supportive of the Commission’s attempts to promote a more proportionate regulatory framework. However, the proposed amendments would provide further simplification in some areas, while reintroducing obligations for manufacturers in others.
We discuss some of the key amendments proposed in the Draft Report below.
Continue Reading How will the EU Parliament shape the MDR/IVDR revision? Draft report indicates how Parliament may seek to amend Commission’s proposalsThe EU Data Act’s Access-by-Design Deadline: What Life Sciences Companies Need to Know Before September 2026
Since 12 September 2025, the EU Data Act (Regulation (EU) 2023/2854, the “EU Data Act”) has required manufacturers of connected products and providers of related services to make in-scope data accessible to users, whether through direct or indirect access mechanisms. On 12 September 2026, a further dimension of that obligation becomes applicable: new connected products and related services placed on the EU market after that date must be designed with direct access capabilities built in by default, where relevant and technically feasible. Because the obligation to provide direct access is explicitly not absolute, manufacturers that already offer users indirect access through a portal or account may find that the practical change is limited.
The September 2026 date is nonetheless a valuable opportunity for companies, including those in the life sciences sector, to review their compliance position: not only on access by design, but across the broader set of EU Data Act obligations that have been applicable for almost a year and are now increasingly attracting scrutiny from marketplaces, customers, and emerging national enforcement bodies.
Continue Reading The EU Data Act’s Access-by-Design Deadline: What Life Sciences Companies Need to Know Before September 2026The EU Packaging and Packaging Waste Regulation: Why Life Sciences Companies Should Act Now
By Fabien Roy, Tom Fox & Camille Vermosen on
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 NowVirtual and Digital Health Digest – June 2026
By Alexander Roussanov, Fabien Roy, Dr Beatriz San Martin, Eleri Abreo, Emma Elliston, Ana Gonzalez-Lamuno, Shama Aktar & Heba Jalil on
Posted in AI, AIMD, CJEU, Cybersecurity, Data protection, Digital Health, EU Legislation, Eudamed, GDPR, Health Research Authority (HRA), IP Law, IVDR, MDR, Medical Devices, software
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 2026Virtual and Digital Health Digest – May 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 2026Virtual and Digital Health Digest – April 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
Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence
By Eleri Abreo on
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 EvidenceEU 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 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