On 27 November 2025, the European Commission published a notice in the Official Journal confirming that the first four modules of the European database on medical devices (EUDAMED) are fully functional. The notice starts a 6 month transition period at the end of which companies in the medical devices supply chain, as well as Notified Bodies and competent authorities, will need to comply with a range of new obligations regarding registrations and data submission under the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), as applicable. These include mandatory registration of devices and of economic operators.

Continue Reading New Medical Device and IVD Registration and Transparency Requirements to Apply in 2026

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

On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).

Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?

A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.

Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

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 September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.

Continue Reading Virtual and Digital Health Digest – October 2025

[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.

Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]

Following a two year investigation, the UK’s Competition and Markets Authority (“CMA”) has issued its provisional findings in which it proposes to impose significant obligations on veterinary business.

Continue Reading The Dog That Barks: The UK’s CMA is proposing major reforms to Veterinary Businesses

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.

Continue Reading MHRA and NICE launch aligned approvals pathway

On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law.  The request follows an order for a preliminary reference made by the BVerwG in March 2025.  Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.

Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines

Article 22 and the Pharma Context

Competition authorities in Europe have for years grown increasingly concerned about so-called “killer acquisitions,” particularly in life sciences where targets often have high innovation potential but little or no turnover. These are transactions where the acquired company’s competitive significance lies in its pipeline, R&D or intellectual property rather than its financials. Such deals can escape traditional turnover-based merger control thresholds, yet – the authorities argue – may still raise serious concerns about future (i.e., potential) competition and innovation. That said, the label “killer acquisition” is something of a misnomer. In practice, transactions undertaken solely to eliminate innovation from a smaller rival are exceedingly rare.

To address this risk, the European Commission has encouraged greater use of Article 22 of the EU Merger Regulation (EUMR), which allows Member States to refer cases for EU review even if they do not meet EU thresholds. Subject to potential further developments, two recent judgments, the Court of Justice’s ruling in Illumina/GRAIL and the General Court’s decision in Brasserie Nationale, now provide the leading interpretation of how Article 22 operates in practice, particularly in relation to call-in powers and timing of referrals.

Continue Reading Article 22 Trends in Pharma M&A: Call-In Powers and Timing