EU Regulatory Framework

Subscribe to EU Regulatory Framework via RSS

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

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 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 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 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

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

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 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