Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Requirements definition

What does Requirements mean? In Development Consent Order (DCO) practice, Requirements are the binding conditions that regulate how, when and on what detailed terms the authorised development may proceed. They typically oblige the undertaker to submit and secure approval of detailed design, construction, and environmental management documents (for example, CEMP, traffic, landscape, contamination and archaeology plans) before commencement, phased works or operation. The term is used in legislation: section 120 of the Planning Act 2008 permits a DCO to impose “requirements”. In most DCOs they are set out in a schedule (often Schedule 2) and function similarly to planning conditions under the Town and Country...

Life sciences product liability under UK CPA 1987 and the EU Revised Product Liability Directive, including AI/software, off‑label use, clinical trials, causation, defences and limitation

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note looks at product liability in the life sciences sector

It centres on the Strict liability framework in Directive 85/374/EEC (the Product Liability Directive (PLD)), its update by Directive (EU) 2024/2853 taking effect from December 2026, and the Consumer Protection Act 1987 (CPA 1987), and explores how these interact with the pharmaceutical and medical devices regulatory regimes. The proposed EU AI Liability Directive (AILD) and its implications are addressed. The Note outlines the statutory elements for establishing liability for defective products, the statutory defences available, and the forms of redress open to an injured party. It further examines responsibility arising from off‑label use of medicines and medical devices, and liability issues in the context of clinical trials. The UK’s product liability architecture predominantly originates in EU law. Numerous EU-derived principles and obligations have been carried over into UK domestic law, unless particular provisions state otherwise. Accordingly, the EU and UK positions are treated side by side: points on EU legal Requirements should generally be read as applicable to the UK approach, save where UK rules diverging from EU legislation are described separately. “Assimilated law” is the term used for retained EU law (REUL) that remains in force...

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Web page updated on 21/05/2026

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