The new Product Liability Directive (“PLD”) replaced the old Product Liability Directive (Directive 85/375/EEC) and aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global supply chains. It also focuses on improving the harmonisation of the common rules on liability for defective products and tackling the difficulties faced by victims when gathering evidence to prove product liability. This blog focuses on the main changes the PLD brings.
Entry into force
The PLD entered into force on 8 December 2024. The PLD applies to products placed on the market or put into service after 9 December 2026 (Article 2). As a result, the PLD should be transposed into Belgian law by this date.
The rules on product liability can be found in Articles 6.41 to 6.55 of the Belgian civil code. Book 6 of the civil code entered into force on 1 January 2025. Articles 6.41-6.55 of the Belgian civil code have not yet been brought into line with the PLD.
The PLD’s main principles
The PLD is based on two main principles: (i) the manufacturer must compensate for the damage caused by a defective product, and (ii) the victim (a natural person) must prove that the product was defective, that he/she has suffered damage and that the damage was caused by the defective product.
The PLD’s main changes
Listed below are the PLD’s most noteworthy changes:
1) The definition of “product” is expanded to digital manufacturing files, software (such as AI), digital services that are integrated into, or inter-connected with, a product in such a way that the absence of the service would prevent the product from performing one of its functions (e.g. navigation systems) (Article 4(1) PLD). This means that companies that develop, for instance, health-tracking apps designed to treat or diagnose specific diseases will fall within the PLD’s scope.
2) The scope of “damage” is no longer limited to damages caused by death, personal injury or damage to property items (except for the defective product itself). It now also includes corruption of data (such as content deleted from a hard drive), the cost of recovering and restoring the data (irrespective of any damages due under other EU instruments, such as the GDPR) and medically recognised damage to psychological health (a term that the PLD Proposal has not defined but, in its preambles, the PLD refers to the International Classification of Diseases of the World Health Organization). Moreover, the 500 EUR minimum threshold for property damage is removed.
3) The PLD includes a non-exhaustive list of circumstances that may be relevant in assessing the defectiveness of a product (Article 7(2)), such as the moment in time when the product was placed on the market. The PLD also refers to the moment when the product was put into service or, where the manufacturer retains control over the product after that moment, the moment in time when the product left the manufacturer’s control. In other words, not only the time of placing the product on the market will be considered, but also the period during which the product remains under the manufacturer’s control.
4) Burden of proof. The PLD introduces, in certain situations, a rebuttable presumption of defectiveness (Article 10(2)) and the existence of a causal link (Article 10(4)). The defectiveness of a product will be presumed in three situations:
- (i) The defendant fails to disclose relevant evidence (see point 5 below);
- (ii) the claimant demonstrates that the product does not comply with mandatory product safety requirements laid down in Union or national law that are intended to protect against the risk of the damage suffered by the injured person;
- (iii) the claimant demonstrates that the damage was caused by an obvious product malfunction during reasonably foreseeable use or under ordinary circumstances.
The existence of a causal link will be presumed where it has been established that the product is defective and that the damage caused is of a kind typically consistent with the defect in question.
The defendant can rebut these presumptions.
Moreover, the product’s defectiveness or the causal link between its defectiveness and the damage, or both, will be presumed, despite the disclosure of evidence (see point 5 below), and taken into account in all of the case’s circumstances if:
- (i) the claimant faces excessive difficulties, in particular due to technical or scientific complexity, in proving the product’s defectiveness or the causal link between its defectiveness and the damage, or both; and
- (ii) the claimant demonstrates that it is likely that the product is defective or that there is a causal link between the product’s defectiveness and the damage, or both.
In the context of medical devices, the CJEU ruled, under the old Product Liability Directive that “where it is found that products belonging to the same group or forming part of the same production series, such as pacemakers and implantable cardioverter defibrillators, have a potential defect, such a product may be classified as defective without there being any need to establish that that product has such a defect.” (joined cases C-503/13 and C-504/13, paragraph 43). In this scenario, the burden of proof is made considerably easier for the claimant. There is no (recent) CJEU case law in which this principle has been applied to other types of products or groups of products. So, it is currently unclear whether this principle can be successfully applied in other sectors.
5) The introduction of a disclosure obligation. Manufacturers are obliged to disclose necessary information in court when the injured person has presented facts and evidence sufficient to support the “plausibility of the claim for compensation” (Article 9(1)). The manufacturer’s disclosure obligation is limited to relevant evidence that is at its disposal, and to what is necessary and proportionate. The PLD underscores that Member States must ensure that the legitimate interest of all parties concerned is considered (including third parties) and in particular regarding the protection of confidential information and trade secrets.
National courts can require that the evidence is presented in an easily accessible and understandable manner (if such is deemed proportionate by the national court regarding the costs and effort for the required party). This could be necessary in situations that involve AI software.
The PLD leaves it up to the member states to determine penalties for non-compliance with this obligation (preamble 43).
Conclusion
As the burden of proof for consumers has become easier because of the rebuttable presumptions and disclosure obligations for manufacturers, we expect consumers to initiate more product liability claims.
Manufacturers of products that fall within the PLD’s scope should be aware of this change and might consider (i) updating their insurance policies and (ii) developing a process for collecting information that might need to be disclosed under the PLD.