Module 17 2024

04/12/2024

Product Safety – v- Product liability

Legal duties on those who market products enforced via injured persons, (e.g. patients) bringing compensation claims before the civil law courts

Legal duties on those who market products enforced via public law regulatory authorities, (e.g. MHRA) – often via criminal law

Claims by persons injured by a product are based on: • Breach of a contract for sale of goods • Negligent design, manufacture or marketing • Damage caused by a defect in a product (revised EU PLD / Consumer Protection Act 1987) • Medicines & Medical Devices Act 2021 • Draft AI Liability Directive

Legislation setting out acceptable health & safety levels for products : •“New Approach” legislation (e.g. EU MDR) •“New Legislative Framework” (NLF) 2008 – 2019, e.g. RAMS (Regs

765/2008/EC & 2019/2010/EU) • EU AI Act 2024

3

3

Product liability

4

TOPRA MSc Module 17

4

2