Jurisdiction(s):
United Kingdom

EU cybersecurity regime for life sciences: NIS 2, MDR/IVDR, GDPR, AI Act, EHDS and CRA—scope, obligations, incident reporting, sanctions and practical guidance

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note delivers a succinct overview of cybersecurity challenges for life sciences businesses, coupled with practical guidance for EU-based organisations. It charts the EU regulatory landscape for cybersecurity, including the NIS 2 Directive, Medical Devices Regulations (MDR and IVDR), the EU AI Act, the EU Cyber Solidarity Act, the EU Cyber Resilience Act, and the European Health Data Space Regulation (EHDS), and outlines compliance duties alongside the sanctions or enforcement outcomes for non-compliance. It also identifies key regulatory authorities and industry bodies, and closes with insights into legislative trends and the likely direction of travel...

The cybersecurity landscape in the life sciences sector

The life sciences sector—covering R&D of pharmaceuticals, medical devices and biotechnology; clinical trials; and healthcare services—now embeds digital technologies such as telemedicine, health apps and artificial intelligence to enhance operations and drive innovation. This digital shift, however, brings cybersecurity risks. For the purposes of this Practice Note, cybersecurity means protecting data and systems from unauthorised or malicious access, use, disclosure, modification or destruction...

Cybersecurity is vital because life sciences organisations handle vast quantities of sensitive health data, including patient records and clinical trial...

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Web page updated on 21/05/2026

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