Module 16 2024

22/10/2024

Fault/Negligence Liability (cont.)

For highly technical products, difficult to prove

● unreasonable conduct ● that this caused injury

Must show material contribution to the damage and device was “proximate” cause of injury

Often multiple risk factors, possible causes and uncertain mechanisms

The Organisation for Professionals in Regulatory Affairs

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EC Strict Liability Doctrine

Directive 85/374/EEC

Establishes the principle of no-fault liability for producers in cases of damage caused by a defective product

Currently undergoing revision

● Expanded scope to cover raw materials, software and services integrated into a product

The Organisation for Professionals in Regulatory Affairs

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