Disputes and regulatory enforcement

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Regulatory enforcement and actions against regulators

The highly regulated nature of the life sciences industry gives rise to the potential for a myriad of regulatory enforcement action for breach of the strict rules governing the sector. Similarly, organisations affected by decisions taken by the regulators responsible for regulating the sector may also wish to take action against those decisions. Regulatory enforcement and action against regulators is possible at both at UK and EU level, depending on the nature of the issue in dispute.

Disputes arising out of the EMA’s approach to transparency

Article 15 of the Treaty on the Functioning of the European Union (TFEU) requires EU institutions, bodies, offices, and agencies to conduct their work as openly as possible and extends the public right of access to documents of all the Union institutions, bodies, offices and agencies. This is often referred to as the principle of transparency. Transparency can be pursued by institutions either by granting access to documents or information upon request (reactive disclosure) or by making documents and information publicly available on their own motion, mainly by publishing it on their websites (proactive disclosure).

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Latest Life Sciences News

Life Sciences weekly highlights—3 July 2025

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.

DHSC and NHS England announce new 'innovator passport' system for healthcare technology

The Department of Health and Social Care (DHSC) and NHS England have announced plans to introduce an 'innovator passport' system over the next two years. The digital system, delivered through the MedTech Compass platform, will enable healthcare technology assessed by one NHS organisation to be implemented across other NHS bodies without requiring repeated compliance assessments. The initiative forms part of the government's 10 Year Health Plan and aims to streamline technology adoption processes across the NHS. The system will operate as a centralised platform for NHS organisations to access information about assessed healthcare technologies and their supporting evidence.

DHSC announces legislation for NHS single patient record system

The Department of Health and Social Care (DHSC) has announced plans for new legislation requiring healthcare providers to contribute to a single patient record system, classified as Critical National Infrastructure. The legislation will mandate all health and care providers to make patient information available in the unified system and give patients default access to their records. The system, due to launch in 2028, will be built to security standards equivalent to vital national infrastructure systems. Healthcare professionals will have secure access to patient records, with patients maintaining control over additional access permissions and receiving audit trails of record access.

New MDCG guidance on the interplay between the MDR/IVDR and the EU AI Act

Life Sciences analysis: Hélène Boland, senior associate and Fabien Roy, partner of Hogan Lovells, consider the key takeaways from the MDCG 2025-6 guidance on the interplay between the MDR/IVDR and the EU AI Act.

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