This week's edition of Life Sciences weekly highlights includes analysis from partners of Hogan Lovells on the key takeaways from new MDCG 2025-6 guidance on the interplay between the Medical Device Regulation/In Vitro Diagnostic Medical Device Regulation and the EU AI Act. Also included, is news that the MHRA opened applications for an expanded AI Airlock programme following last year’s pilot and published the much-anticipated guidance to support implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28 April 2026; the European Commission adopted new rules allowing all medical devices used by professionals to include electronic instructions for use; the DHSC announced the development of an AI system to monitor NHS patient safety in real time; and the European Notified Bodies industry group (TEAM-NB) released an updated version of its position paper on software classification under the IVDR, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Bristows on the new 2024 Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice governing the advertising of medicines and healthcare sector interactions with the UK pharmaceutical industry which will be enforced from 1 January 2025. Also included, is news that the EMA adopted a reflection paper on using AI and machine learning (ML) in drug development, the European pharmaceutical industries body (EFPIA) has issued a critical position paper on the European Health Data Space (EHDS) Regulation’s opt-out mechanism providing important recommendations and it published an article highlighting issues caused by the narrow definition of ‘unmet medical needs’ in the EU General Pharmaceutical Legislation reform package, and news that the UK government stopped commencement of section 6 of the Retained EU Law (Revocation and Reform) Act 2023, involving a new legal test to diverge from EU High Court case precedent as part of its work on a UK-EU ‘reset’.

This week's edition of Life Sciences weekly highlights includes news that the MHRA has tabled three amendments to the Health Bill aimed at modernising the legislative framework for the regulation of medicines and medical devices. Also included is news that NICE will update its value set for the calculation of quality-adjusted life years used to assess whether treatments are cost-effective for the first time since 2012, the MHRA has updated its pharmacovigilance procedures guidance concerning periodic safety update reports and the EU Reference Dates (EURD) list, and that the EMA and Heads of Medicines Agencies have launched a consultation on a draft framework for managing data standards across the European medicines regulatory network.

This week’s edition of Life Sciences weekly highlights includes news that the Tobacco and Vapes Bill has received Royal Assent, introducing measures to create a smoke-free generation, restrict the advertising and promotion of vapes and strengthen enforcement against illicit sales. This week also saw the entry into force of the new UK clinical trial regulations, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, introducing a fast-track pathway for lower-risk trials, mandating trial registration and results publication, and streamlining approval processes. Further news included is that Medicines for Europe released a detailed factsheet with graphics on the proposed EU Biotech Act, highlighting structural challenges and setting out key pillars to support innovation and manufacturing in the biosimilars sector. It and its member industries also have issued a statement explaining its appeal to the European Court of Justice against a decision rejecting their standing to challenge the Urban Wastewater Treatment Directive calling for a review of its Extended Producer Responsibility (EPR) scheme, raising concerns about disproportionate and discriminatory financial burdens and potential impact on medicines supply. In the medical devices space, the MDCG has published updated guidance on the European Medical Device Nomenclature, clarifying code use and device classification.

This week's edition of Life Sciences weekly highlights includes news that the European Commission introduced the competitiveness compass, which will guide the Commission’s work for the next five years and summarises the key legislation to be introduced to achieve these objectives for IP and life sciences. Also included, is news that the Court of Appeal dismissed an appeal by Merck in a case that questions the interplay of patents for second medical uses and the SPC regime and the CJEU precedent set by Neurim Pharmaceuticals, final guidelines setting international standards for good machine learning and risk characterisation for medical device software has been published, and Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for joint scientific consultations for medical devices under the Health Technology Regulation was published in the Official Journal of the EU. Other stories include news that the European Commission launched a new Biotech and Biomanufacturing Hub to foster innovation and support the European biotech sector, the EU Borderline Manual on Cosmetic Products was updated, the European Shortages Monitoring Platform (ESMP) has fully launched before becoming mandatory on 2 February 2025, new EU guidelines on the use of specific adverse reaction follow-up questionnaires were released, and international guidelines for good clinical practice under ICH E6(R3) were published; among other stories.

This week’s edition of Life Sciences weekly highlights includes news that the Digital Omnibus on AI has entered into force, amending the EU AI Act and related sectoral legislation to simplify the implementation of harmonised rules on AI. Also included is news that the MHRA has published guidance on ambient voice technologies, clarifying the scope within medical device regulatory determinations. Further news includes the MHRA updating its AI Airlock Phase 2 programme report and publishing candidate-led case study reports addressing regulatory issues for AI as a medical device (AIaMD), as well as news that the Court of Appeal has dismissed the appeals of Auden Mckenzie, Actavis and Allergen and Instas against the Competition Appeal Tribunal’s judgment affirming the Competition and Market Authority’s infringement decision for excessive and unfair pricing, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis on ESG trends emerging from the UK’s commitments to tackle antimicrobial resistance (AMR) by Freshfields Bruckhaus Deringer LLP. Also included is news that the Council of the EU formally approved the Regulation on Substances of Human Origin (SoHO) to expand and improve the safety and quality of blood, tissues and cells for use in humans and their cross-border movement, the European Commission adopted new rules for joint clinical assessment of medicines for the implementation of the new Regulation (EU) 2021/2282, Health Technology Assessment (HTA Regulation), WIPO Member States approved the world’s first Treaty about intellectual property based on genetic resources and associated traditional knowledge, NICE and NHS England have jointly opened a consultation on a new fast-track for MedTech developers to access NHS funding, the first UK Government Champion for Personalised Prevention published his report, the Data Protection and Digital Information Bill has been lost in the ‘wash-up’ period ahead of the UK general election, the Council of the EU adopted new rules revising the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent shortages of medical devices and enhance transparency and accessibility to information and, Moderna has successfully defended a key patent underpinning its coronavirus (COVID-19) vaccine, among other news.

This week's edition of Life Sciences weekly highlights includes a Law360 analysis of the Court of Justice upholding a €60.5m fine against Teva and Cephalon in a long-running pay-for-delay case involving a generic version of a blockbuster narcolepsy treatment, and an MLex analysis reporting that the European Commission is considering changes to how the EU AI Act applies to products regulated under sector-specific legislation, such as medical devices, as part of a wider digital ‘omnibus’ package expected on 19 November 2025. Also included is news that MedTech Europe has called for EU rules changes to permit electronic instructions for use (eIFUs) for near-patient testing devices, also known as point-of-care (POC) testing, the MHRA announced a new AI-driven project to predict drug interaction side effects, and together with the Health Research Authority (HRA) outlined preparations for clinical trials reform due to take effect from 28 April 2026, including the establishment of an advisory group on simplified arrangements for consent in low intervention clinical trials, the EMA opened a consultation on the use of non-human primates in safety testing and implementation of the 3Rs (replacement, reduction and refinement) principles, as well as news that the Health Economics Methods Advisory (HEMA) has published its first draft report for public comment on the factors that should be considered in health technology assessment (HTA) and the MHRA Criminal Enforcement Unit dismantled the UK’s first major illicit manufacturing facility distributing unlicensed weight loss jabs, among other stories.

This week's edition of Life Sciences weekly highlights includes a Law360 report on the Court of Appeal’s decision against generic-drug makers to set aside remaining protections for Astellas Pharma’s blockbuster prostate cancer treatment and analysis by Freshfields of the European Commission’s Guidelines on the scope of obligations for general-purpose AI (GPAI) models. Further news stories this week include news that EU Notified Bodies have published a detailed position paper proposing reforms to medical device governance, the European pharmaceutical industry expressed concerns about the impact of the US-EU trade deal setting a 15% tariff on pharmaceuticals, the DSIT published guidance detailing the implementation timeline for the Data (Use and Access) Act 2025, the European Parliament has recommended a strict liability regime for high-risk AI systems in its study examining the EU’s regulatory approach to civil liability for AI systems and MedTech Europe has published a position paper calling for guidance reform of the sampling requirements for diagnostic devices to be changed to a risk-based model. Also included, is news that the EMA intends to draft a reflection paper on the use of external controls in clinical trials to support regulatory decisions, amending Regulation (EU) 2025/788 has been adopted delaying the application date of the Master UDI-DI solution for contact lenses one year until 9 November 2026, the BioIndustry Association’s Q1 2025 finance report reflects healthy UK biotech venture capital investment raising £1.23bn and the MHRA opened a consultation on the effectiveness of the Medicines and Medical Devices Act 2021; among other stories.

This week's edition of Life Sciences weekly highlights includes news that the UK government announced its Autumn Budget which featured several funding initiatives to boost innovation and improve infrastructure to support the life sciences, the European Parliament has passed a resolution acknowledging the urgent need to revise the medical device regulations and calling on the Commission to propose delegated and implementing acts to achieve these reforms by end of Q1 2025, the European Association of Medical devices Notified Bodies (Team-NB) has aligned on a strategy to address challenges encountered with the implementation of the medical devices regulations, the European pharmaceutical industry issued its position on AI use in the lifecycle of a medicinal product broadly supporting the EMA’s AI/ML reflection paper, and news that the Commission has adopted an Implementing Regulation that sets out the rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations under the Health Technology Assessment Regulation and it launched a consultation on a draft implementing act on joint scientific consultations on medical devices, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis of the Court of Justice’s decision overturning the earlier judgment of the General Court in Debrégeas et associés Pharma SAS (D&A Pharma) regarding the conflict of interests of EMA experts when examining an application for a marketing authorisation by Arnold & Porter. Also included is news that the House of Lords’ Science and Technology Committee launched a call for evidence on engineering biology, the European pharmaceutical industry (EFPIA) have requested reforms for the incoming joint clinical assessments (JCA) system as part of the Health Technology Assessment (HTA) Regulation and released the 2024 first quarterly edition of the Navigating Innovation & Research Opportunities (NIRO), and the Health Research Authority (HRA) has released a draft Investigator Initiated Study Agreement for use between non-commercial sponsors and commercial organisations, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Bird & Bird of new MDCG guidance on the interplay between the Medical Devices Regulation (MDR) and the EU AI Act for AI-enabled medical devices, providing both EU and UK perspectives, and analysis by Mishcon de Reya of recent ASA decisions on misleading claims in the beauty industry. Also included is news that the Commission announced that the first four European Database on Medical Devices (EUDAMED) modules will become mandatory from 28 May 2026, and has published results of its second survey on EU medical device market availability, as well as news that the government has announced a UK-US pharmaceuticals deal, establishing a preferential tariff framework for medicinal products, NICE announced that cost-effectiveness thresholds for new medicines will rise from April 2026, the EU Member State Coordination Group on Health Technology Assessment (HTACG) adopted its 2026 Health Technology Assessment Work Programme. Further news includes the Council of the EU’s agreed position on the Critical Medicines Act and EFPIA’s response and news that International Council for Harmonisation (ICH) has adopted three final pharmaceutical guidelines and endorsed three draft guidelines, the ABPI published its annual clinical trials report showing a 25% decline in UK commercial clinical trial recruitment, the Science, Innovation and Technology Committee launched an inquiry into the potential harms associated with hair and beauty products, and the EU has launched new health crisis preparedness and response plan, among other stories.