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Latest Life Sciences News

Commission opens feedback period on medical device regulation proposal

The European Commission has opened an eight-week feedback period on its proposal for a regulation to revise EU rules for medical devices and in vitro diagnostics. The proposal (COM(2025)1023) aims to simplify existing regulations and make safety requirements more cost-efficient and proportionate, whilst ensuring availability of safe and innovative devices to maintain patient safety and public health standards. The initiative seeks to enhance competitiveness of the EU medical device sector in internal and global markets, support innovation and reduce dependencies. All feedback received will be summarised by the Commission and presented to the European Parliament and Council to inform legislative debate. The consultation runs from 7 January 2026 to 4 March 2026.

IMDRF publishes strategic plan 2026-2030

The International Medical Device Regulators Forum (IMDRF) has published its strategic plan for 2026–2030, outlining measures to accelerate global regulatory convergence for medical devices and strengthen governance. The plan sets out five strategic focus areas: (1) modernising governance to support sustainable and transparent growth; (2) reinforcing foundational regulatory principles by converting legacy Global Harmonization Task Force (GHTF) documents into updated IMDRF guidance; (3) addressing regulatory challenges posed by innovative technologies through the development of new technical documents and joint workshops with the IMDRF Industry Group; (4) expanding stakeholder engagement through new and enhanced mechanisms for participation and outreach; and (5) strengthening support for the implementation of IMDRF documents through training and practical guidance. To support consistent application across jurisdictions, the plan also calls for a more systematic and structured approach to IMDRF training programmes. The plan builds on progress made during the 2021–2025 strategic period, which was marked by rapid technological innovation, increased use of regulatory reliance mechanisms and significant regulatory disruption arising from the coronavirus (COVID-19) pandemic. During this time, regulators faced accelerating technological developments, including artificial intelligence (AI), machine learning (ML) and digital therapeutics, while adapting regulatory systems to pandemic-related pressures. IMDRF responded by issuing guidance on personalised medical devices, Software as a Medical Device (SaMD), AI-enabled medical devices and cybersecurity, and by developing the Reliance Playbook to promote more efficient and coordinated regulatory cooperation.

New terms of reference for UK product liability reform project

Life Sciences analysis: On 8 December 2025, the UK Law Commission published its Terms of Reference (ToR) for its product liability law review, providing some further insight into the project. As we anticipated earlier in the year, the scope of the project is broad and the trend may well be towards a more claimant-friendly regime, as in the EU. The Life Sciences team at Freshfields LLP considers the issues.

Compulsory licensing regulation for crisis management to come into force in EU on 19 January 2026

The European Commission's Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs has announced that the regulation on compulsory licensing for crisis management, amending Regulation (EC) No 816/2006, will come into force on 19 January 2026 following its publication in the Official Journal of the European Union. The regulation establishes an EU-wide framework for granting compulsory licences in cross-border crisis or emergency situations, enabling the Commission to issue EU-wide compulsory licences for protected inventions related to crisis-relevant products once a crisis has been declared under relevant EU crisis instruments. Compulsory licensing under the regulation is intended as a measure of last resort, subject to strict conditions, including limits on the scope and duration of licences and obligations to provide fair and adequate remuneration to rights holders in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).