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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 2026

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 proposals

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 June and early July 2026 from the United Kingdom and European Union.

AI continues to be at the top of the agenda for regulators in Europe. The European Commission (EC) has been focused on preparing for the majority of the provisions in the AI Act to come into force this August. Among those provisions are the transparency requirements, and to assist organizations with compliance, the EC has published a voluntary Code of Practice on the marking and labeling of AI-generated content. Further, a Scientific Panel and an Advisory Forum have been appointed to advise the EC’s AI Office and national competent authorities on implementation and enforcement of the AI Act.

In the UK, we are seeing a continued commitment to regulating AI through guidance and codes of practice, as well as the provision of regulatory support through sandbox programs. The Information Commissioner’s Office (ICO), the data protection regulator, has published its plan for upcoming work in relation to AI, which sets out various plans for guidance and codes of practice. The Medicines and Healthcare products Regulatory Agency (MHRA) continues its focus on regulatory sandboxes and recently reported the outcome of the second phase of the AI Airlock. It has also announced further AI sandboxes in order to accelerate the development of medicines and to allow innovators to test AI tools that have the potential to predict how medicines behave in the body, and another, which will be London-focused.

The key legislative development this month is that the EU Council has adopted its position on the first part of the Biotech Act, which, together with the European Commission’s draft, will form the basis of the trilogue discussions between the European Union (EU) institutions, hopefully leading to agreement on a finalized text. 

Continue Reading Virtual and Digital Health Digest – July 2026

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 and re-certifications, as well as aiming to avoid inconsistent practices between Notified Bodies.

To achieve these objectives, the Implementing Regulation sets maximum timelines for Notified Body assessments, provides for standardised rules around quotes by Notified Bodies for carrying out assessments and standardises certain information and verification requirements. The Implementing Regulation also requires each Notified Body to monitor and report on the duration and costs of its assessment activities. Manufacturers will, therefore, have better oversight of the performance of each Notified Body when selecting one to carry out an assessment.

The Implementing Regulation has been developed in response to the inconsistent and divergent interpretation of the procedures for Notified Body assessments under the EU Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), which makes the processes unpredictable for manufacturers.

The European Commission had previously published the implementing regulation in draft form in December 2025 and opened a consultation, which closed in January 2026.

Continue Reading EU implements new rules on uniform procedural requirements for Notified Body assessments

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

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

Introduction

The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and a call for evidence in September 2025 (see our blog here). The proposals respond to industry concerns over complexity, cost, and delays which have been substantially hammering the MedTech industry since the implementation of the MDR and IVDR.

The proposals aim to streamline regulatory processes, reduce administrative burden, and enhance predictability, while maintaining patient safety and public health. From adaptive pathways for breakthrough and orphan devices to leaner conformity assessments, stronger notified body (NB) governance, and changes to classification, these changes are designed to future-proof the regulatory framework and foster innovation. For manufacturers, healthcare institutions, innovators, and industry stakeholders, the proposals signal a shift toward a more proportionate, risk-based system that supports timely access to critical technologies without compromising quality.

Below, we have set out an overview of some of the key proposals.  Additionally, while not released with the proposals, the European Commission published a draft Implementing Regulation on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies – see our separate blog on this here.

The proposals have now been submitted to the European Parliament and Council for review. Once the Parliament and Council have adopted their own positions on the text, there will be negotiations to agree a final text which can be formally adopted by the Council and the Parliament. At this stage, it is challenging to anticipate what would be the result of the political negotiations and unclear when the new rules will start to apply.

A feedback period has been opened, running from 7 January to 5 March 2026. All feedback received will be summarised by the Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.

Continue Reading From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR

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

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.

This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s  proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).

The provisional agreement must now be formally adopted by both the Parliament and the Council.

Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products

The EU Commission has published its proposal for the “Digital Omnibus” aimed to simplify and streamline the EU rules governing artificial intelligence, data protection, cybersecurity, and data use more broadly. The proposal seeks to amend several cornerstone EU regulations, including Regulation (EU) 2016/679 (GDPR), Regulation (EU) 2024/1689 (AI Act), Regulation (EU) 2023/2854 (Data Act), Directive 2002/58/EC (e-Privacy Directive) and Directive (EU) 2022/2555 (NIS2). The proposal also foresees the repeal of the fairly recent Regulation (EU) 2022/868 (Data Governance Act).

Below is a high-level snapshot of the proposal, ahead of a more detailed advisory we will publish.

The proposal will now moves through what is expected to be a challenging legislative procedure and policy and political discussions with the European Parliament and the Council.

Below we set out a quick overview of the most relevant elements for companies, including medical device manufacturers and other Life Sciences companies – e.g., changes to the AI Act, updates to the GDPR, reform of the EU cookie and tracking rules, data-sharing rules, and the new single-entry point for cybersecurity and data protection incidents reporting.

Continue Reading Digital Omnibus: The European Commission published its proposal to amend the GDPR, AI Act, Data Act and other related frameworks