Introduction
As the days grow shorter and the year comes to a close, we’re delighted to bring you a festive winter edition of Vital Signs —your seasonal guide to the legal developments shaping the life sciences and healthcare sector. This time of year invites reflection as well as anticipation, and the industry is no exception: regulatory updates, policy shifts, and emerging technologies continue to evolve at a brisk pace, even as the world slows down for the holidays.
In this edition, we unwrap the latest insights on the UK Government proposal to create a new HDRS, including its potential impact on the sector, key milestones for 2026 and issues around privacy and cybersecurity. We also look back on the initial impact of the Procurement Act 2023, since it came into force in February 2025, and further changes expected for next year. For those with a focus on real estate, we offer practical tips and considerations for constructing life sciences facilities, given their complex design and technical requirements.
The New EU Product Liability Directive: What it Means for Life Sciences Companies
The EU’s new Product Liability Directive1 (“new EU PLD”) marks the most significant overhaul of Europe’s strict liability regime since 1985. It will apply to products placed on the market or put into service from 9 December 2026 and fully harmonises core rules across Member States. For Life Sciences companies and suppliers across increasingly digital and data‑driven care pathways, the new EU PLD materially widens potential risk exposure, eases Claimants’ evidential hurdles, and expands the pool of potential Defendants. These changes are likely to drive higher claim volumes, including follow‑on and collective actions, and increase defence costs and early settlement pressures.
Scope: products, components, software and related services
The new EU PLD expressly brings software, including AI systems and embedded or stand‑alone software applications, within the definition of a “product,” alongside digital manufacturing files, raw materials, and electricity. It also treats certain digital services as “components” where their absence would prevent a product from performing one of its functions, provided they are within the manufacturer’s control. In practice, a wide range of Life Sciences offerings now fall squarely within strict liability, including software as a medical device, device firmware and connectivity layers, clinical decision support tools, digital therapeutics, and cloud‑connected monitoring services integrated with wearables.
To read the articles in full, please click here: Vital Signs Winter 2025/26.
