PLD Article 7. Defectiveness

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.

The assessment of defectiveness should take into account the presentation of the product. However, warnings or other information provided with a product cannot be considered sufficient to make an otherwise defective product safe, since defectiveness should be determined by reference to the safety that the public at large is entitled to expect. Therefore, liability under this Directive cannot be avoided simply by listing all conceivable side effects of a product. When determining the defectiveness of a product, reasonably foreseeable use also encompasses misuse that is not unreasonable under the circumstances, such as the foreseeable behaviour of a user of machinery resulting from a lack of concentration or the foreseeable behaviour of certain user groups such as children.

In order to reflect the increasing prevalence of inter-connected products, the assessment of a product’s safety should take into account the reasonably foreseeable effects of other products on the product in question, for example within a smart home system. The effect on a product’s safety of any ability to learn or acquire new features after it is placed on the market or put into service should also be taken into account to reflect the legitimate expectation that a product’s software and underlying algorithms are designed in such a way as to prevent hazardous product behaviour. Consequently, a manufacturer that designs a product with the ability to develop unexpected behaviour should remain liable for behaviour that causes harm. In order to reflect the fact that in the digital age many products remain within the manufacturer’s control after being placed on the market, the moment in time a product leaves the manufacturer’s control should also be taken into account in the assessment of a product’s safety. A product can also be found to be defective on account of its cybersecurity vulnerability, for example where the product does not fulfil safety-relevant cybersecurity requirements.

In order to reflect the nature of products whose very purpose is to prevent damage, such as a warning mechanism like a smoke alarm, the assessment of the defectiveness of such a product should take into account its failure to fulfil that purpose.

In order to reflect the relevance of product safety and market surveillance legislation for determining the level of safety that a person is entitled to expect, it should be clarified that relevant product safety requirements, including safety-relevant cybersecurity requirements, and interventions by competent authorities, such as issuing product recalls, or by economic operators themselves, should be taken into account in the assessment of defectiveness. Such interventions should, however, not in themselves create a presumption of defectiveness.