Module 5 Presentations

19/07/2024

Strict Liability: EU Product Liability Directive 85/374/EEC

• Various defences available including:

– That the defect was not present when the product was put into circulation (Article 7(b)). – “That the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered” *(Article 7(e)). – “In the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or the instructions given by the manufacturer of the product” (Article 7(f)).

* Defence optional – i.e not implemented by all Member States

The Organisation for Professionals in Regulatory Affairs

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• Likely to be approved imminently and effective within 2 years of coming into force • Aimed to ensure application of legislation to modern products including software and AI • Explicitly includes provision for compensation for psychological injuries • Liability additionally imposed on “fulfilment service providers” • Defect presumed in certain circumstances • Provides for liability for latent damage – up t0 25 years New Product Liability Directive

The Organisation for Professionals in Regulatory Affairs

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