Product Liability Directive (PLD)

(30) In order to protect the health and property of natural persons, the defectiveness of a product should be determined by reference not to its fitness for use but to the lack of the safety that a person is entitled to expect or that is required under Union or national law. The assessment of defectiveness should involve an objective analysis of the safety that the public at large is entitled to expect and not refer to the safety that any particular person is entitled to expect. The safety that the public at large is entitled to expect should be assessed by taking into account, inter alia, the intended purpose, reasonably foreseeable use, presentation, objective characteristics and properties of the product in question, including its expected lifespan, as well as the specific requirements of the group of users for whom the product is intended. Some products, such as life-sustaining medical devices, entail an especially high risk of causing damage to people and therefore give rise to particularly high safety expectations. In order to take such expectations into account, it should be possible for a court to find that a product is defective without establishing its actual defectiveness, where it belongs to the same production series as a product already proven to be defective.