Publication date: October 15, 2025
On October 23, 2024, the European Union adopted new regulations on liability for defective products in the form of Directive 2024/2853 (entered into force on November 18, 2024). Ultimately, the new regulations are intended to ensure a higher level of safety for consumers’ health and property and guarantee them appropriate compensation. Furthermore, the preamble to the act anticipates the need to facilitate innovation and research, and recognizes the upcoming challenges related to the growing popularity of digital services. However, this does not mean that the previous EU legal act on this matter (Directive 85/374/EEC of July 25, 1985) will automatically become null and void, as the new regulations stipulate that it will continue to apply to defective products placed on the market or put into service before its repeal date (December 9, 2026). What other changes has the new directive introduced?
First, it is worth addressing the concepts themselves (especially those introduced by the new directive) that will be used in the document under discussion. As already mentioned, its distinctive element is its discussion of issues related to digitization, hence the concept of “digital production files”, defined as a digital version or template of a movable item containing the necessary information to produce a tangible item through the automated operation of machines or tools.
Also noteworthy are the concepts of “components”, meaning an object (including intangibles), raw material, or service integrated with or interconnected with a given product, and the “distributor”, meaning a natural or legal person making a product available on the market without being its manufacturer or importer.
Newly defined concepts also include: “related service”, “manufacturer’s control”, “data”, “market availability”, “putting into service”, “authorized representative”, “order fulfillment service provider”, “economic operator”, “online platform”, “trade secret”, and “significant modification”. The “product” itself has been defined primarily as a movable item, but in addition to this, electricity, digital production files, raw materials and software are also considered a product.
Damage and defect
The fundamental right guaranteed by this act is the right to compensation for damage caused by a defective product. But how is the concept of “damage” itself defined? According to the directive, the aforementioned right to compensation applies in strictly defined cases: death and personal injury, damage to or destruction of property (excluding the defective product itself, a product damaged by a defective component, and property used exclusively for professional purposes), and, similarly, destruction or damage to data used exclusively for professional purposes.
Furthermore, the right to compensation covers all pecuniary losses resulting from the aforementioned damage, including non-pecuniary losses, but only to the extent that such losses are eligible for compensation under national law. Unlike its predecessor, Directive 2024/2853 does not introduce a monetary limit on damages, which was previously set at €500.
A product should be considered defective if it fails to provide the safety that a person reasonably expects and is required by Community or national law. Several circumstances should also be considered when assessing whether a product is defective, including those that could reasonably be foreseen under normal use, the time the product was introduced into the market, and the specific needs of the users for whom it was intended. However, an item cannot be considered defective simply because a product with better properties is already available on the market.
It is worth emphasizing that the new regulations will cover not only typical property damage, but also personal injury, such as health damage, and more specific damage related, for example, to the irreversible deletion of files from a hard drive.
Who is liable for the damage?
The Directive requires Member States to ensure that the entities listed therein are held liable. These include: the manufacturer of the defective product (in this case, liability also covers damage caused by a defective component part of the product when it was integrated or interconnected with the product under the manufacturer’s control and caused the product’s defect. A manufacturer is also considered a natural or legal person who significantly alters the product outside the manufacturer’s control and then makes it available or puts it into service), the importer of the defective product or component part, the manufacturer’s authorized representative (if the manufacturer is based outside the EU), and the order fulfillment service provider (if there is neither an EU-based importer nor an authorized representative).
Therefore, it can be concluded that manufacturers based outside the EU have identical liability to EU manufacturers. If none of the above-mentioned individuals can be identified, each distributor of the defective product is liable if the injured party contacts them to identify one of the above-mentioned entities or another distributor from whom they received the defective item (if the distributor to whom the request is addressed fails to comply with the request within one month, then the distributor will be liable).
Finally, when compensation cannot be obtained from any of the above-mentioned entities, responsibility for providing appropriate compensation shifts to the state, which should provide appropriate funds from existing sectoral compensation mechanisms or create new ones for this purpose (however, these should not be financed from public funds).
Furthermore, under Article 12 of Directive 2024/2853, if several economic operators are liable for damage, they are jointly and severally liable. Regarding internal settlements between such entities, the directive stipulates that a manufacturer who has previously integrated software as a component of a product has no recourse against the creator of the software itself if that creator is a microenterprise or a small enterprise (as defined in Recommendation 2003/361/EC of the European Commission) or if the entity that integrated the software has waived this claim in a contract.
Evidence in court
On the one hand, Article 10(1) of the new regulations stipulates that the injured party bears the burden of demonstrating the damage suffered and the product’s defect. On the other hand, they provide numerous solutions favorable to consumers. This primarily concerns the presumption of product defect, which applies when the plaintiff demonstrates that the product fails to meet the legally required requirements for minimizing the risk of damage, the damage was caused by the product’s normal, intended use, and the defendant fails to provide appropriate evidence. The same presumption applies to the causal link between the product’s defect and the damage, which may be applied when the product’s defect has already been established in the proceedings, and the damage is consistent with damage typically incurred in similar circumstances.
Furthermore, the injured party encounters certain difficulties in proving such a link, stemming from technical or specialized issues inherent in the product, and when the injured party demonstrates a high probability of such a link. However, it should be noted that the presumption itself is inconclusive and can be easily rebutted by the defendant’s arguments.
Article 9 of the Directive also provides for general obligations regarding the evidence provided, including that it should be limited to what is necessary and proportionate and that it should be presented in an accessible and understandable manner.
Exclusions
Despite many beneficial solutions for the injured party, the directive does not introduce absolute producer liability for damage. Certain circumstances are envisaged that reduce the producer’s liability for damage caused, including when the damage is caused by both a defective product and the fault of the injured party or another person for whom the injured party is responsible.
The party responsible for the damage may also be exempted from liability by demonstrating one of the circumstances listed in Article 11(1) of Directive 2024/2853. In the case of a distributor, this is the failure to make the product available on the market, and in the case of a manufacturer or importer, the failure to put into service or place on the market. Such a circumstance also includes the probability that the defect that caused the damage did not exist at the time the product was placed on the market, put into service, or, in the case of a distributor, made available on the market, or that the defect arose after that time, unless the defect resulted from a related service or a significant modification of the product. At the same time, in accordance with Article 15 of the Directive, the liability of an economic operator under the Directive cannot be excluded either by national law or by an agreement between the injured party and the perpetrator.
The directive also introduces a 10-year limitation period for pursuing damages. This period begins to run from the date the defective product that caused the damage was placed on the market or put into service, or, in the case of a significant modification of the product, from the date it was made available on the market or put into service after such modification. In exceptional cases, if the injured party was unable to pursue their claim due to the hidden nature of the personal injuries, provided that no compensation proceedings were initiated in the meantime.
Implementation in Poland
Under Article 22 of the Directive, Member States are required to take the necessary steps to implement the new Directive by December 9, 2026. Currently, there is no information on the actions taken in this regard in Poland, but it is emphasized that the provisions of the Polish Civil Code will be amended, particularly Title VI, which addresses the issue of liability for dangerous products. Changes will be necessary, in particular, to the concept of “product” itself, as the Civil Code limits it only to movable property, animals, and electricity, and to the definition of “damage” in Article 449[2], which does not address the issue of immaterial damage. At the same time, there should be no changes in personal data protection, liability for reasons other than product defects, or entitlement to legal protection. It is also debatable whether liability under the new regulations would apply to an insurer offering insurance online.
Impact on entrepreneurs
The impact of the new regulations on the legal situation of businesses is widely emphasized. Their liability has been significantly expanded through the introduction of the principle of objective liability. In principle, the obligation to compensate for damage will therefore depend solely on the occurrence of the damage, not on the manufacturer’s fault. It is also worth mentioning the many potential practical consequences: increased operating costs (more stringent measures regarding product testing and traceability, investments in a new quality management system and personnel), the need to adapt business processes (to comply with the new regulations, businesses may be forced to redesign products or change production methods). However, companies will have an opportunity to comply with the new regulations, and customers will be more likely to trust companies that actually meet the new requirements, particularly in terms of safety and transparency. To maintain this, it is also recommended to create and maintain comprehensive product documentation, including detailed description, safety measures, test results, and updates, as well as provide employees with appropriate training.
Summary
The new EU Directive 2024/2853 is certainly a response to the changing conditions in our daily lives, primarily those related to new digital services. This act addresses these challenges by defining the concept of “digital production files” and no longer limiting compensable damage solely to financial losses. Benefits for injured parties have been introduced (abolishing the previously applicable €500 threshold for damage and presuming product defects; liability may also extend beyond the manufacturer). While this does not completely discredit producers, who can still be exempt from liability by demonstrating appropriate circumstances, the new regulations do pose further challenges for them in terms of staff training and possibly requiring changes to their production systems.