Coronavirus (COVID-19)

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This subtopic brings together news and other resources regarding the implications of the coronavirus (COVID-19) pandemic for the UK and European life sciences industry.

Regulatory implications for the UK and European life sciences industry

Coronavirus (COVID-19) presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators have provided guidance in response to the crisis, as well as to support research and development (R&D) designed to contain the impact of the pandemic.

For a discussion of the key regulatory implications

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Latest Life Sciences News

Life Sciences weekly highlights—8 January 2026

This week's edition of Life Sciences weekly highlights includes several key analyses: an analysis of the Commission’s Digital Omnibus on AI Regulation Proposal and key considerations for life sciences companies by Hogan Lovells and an MLex analysis of the Commission’s proposal to ease application of the EU AI Act’s high-risk regime for medical devices. Also included are an analysis of the UK Law Commission’s published Terms of Reference for its product liability law review by Freshfields LLP, analysis of the UK government’s announcement of a landmark UK–US pharmaceutical deal by Covington & Burling LLP, an MLex analysis of the Unified Patent Court’s revocation of GXD-Bio’s breast cancer testing patent, an analysis on how to avoid misleading claims in the beauty industry by Mishcon de Reya and analysis of the ASA final guidance on less healthy food and drink advertising by Lewis Silkin. Other stories include news that the Commission has opened a feedback period on its proposal for a regulation to revise EU rules for medical devices and in vitro diagnostics, the Commission has published new MDCG guidance on post-market surveillance and breakthrough devices, the MHRA has opened a call for evidence on the regulation of AI in healthcare, and has updated its guidance on the Health Institution Exemption for medical devices, the International Medical Device Regulators Forum (IMDRF) published its strategic plan for 2026–30, and news that the EU regulation on compulsory licensing for crisis management will enter into force on 19 January 2026, among other stories.

Myriad wins UPC ruling as GXD-Bio breast cancer patent is revoked

MLex: The Unified Patent Court revoked GXD-Bio’s breast cancer testing patent, rejecting infringement claims against Myriad’s EndoPredict breat cancer test and clearing the way for continued European marketing after finding added subject matter.

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.

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