Data & Privacy
- Data Act
- Data Governance Act
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
Product Liability Directive
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 4
CHAPTER II
SPECIFIC PROVISIONS ON LIABILITY FOR DEFECTIVE PRODUCTSArticles 5 — 11
CHAPTER III
GENERAL PROVISIONS ON LIABILITYArticles 12 — 17
CHAPTER IV
FINAL PROVISIONSArticles 18 — 24
ANNEXES
PLD Article 4. Definitions
- For the purposes of this Directive, the following definitions apply:
- (1)‘product’ means all movables, even if integrated into, or inter-connected with, another movable or an immovable; it includes electricity, digital manufacturing files, raw materials and software;
- (2)‘digital manufacturing file’ means a digital version of, or digital template for, a movable which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;
- (3)‘related service’ means a digital service that is integrated into, or inter-connected with, a product in such a way that its absence would prevent the product from performing one or more of its functions;
- (4)‘component’ means any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;
- (5)‘manufacturer's control’ means that:
(a)
the manufacturer of a product performs or, with regard to actions of a third party, authorises or consents to:(i)the integration, inter-connection or supply of a component, including software updates or upgrades; or(ii)the modification of the product, including substantial modifications;(b)
the manufacturer of a product has the ability to supply software updates or upgrades, themselves or via a third party;
- (6)‘data’ means data as defined in Article 2, point (1), of Regulation (EU) 2022/868 of the European Parliament and of the Council ;
- (7)‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
- (8)‘placing on the market’ means the first making available of a product on the Union market;
- (9)‘putting into service’ means the first use of a product in the Union in the course of a commercial activity, whether in return for payment or free of charge, in circumstances in which that product has not been placed on the market prior to its first use;
- (10)‘manufacturer’ means any natural or legal person who:
(a)
develops, manufactures or produces a product;(b)
has a product designed or manufactured, or who, by putting their name, trademark or other distinguishing features on that product, presents themselves as its manufacturer; or(c)
develops, manufactures or produces a product for their own use;
- (11)‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer's behalf in relation to specified tasks;
- (12)‘importer’ means any natural or legal person who places a product from a third country on the Union market;
- (13)‘fulfilment service provider’ means any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching of a product, without having ownership of that product, excluding postal services as defined in Article 2, point (1), of Directive 97/67/EC of the European Parliament and of the Council , parcel delivery services as defined in Article 2, point (2), of Regulation (EU) 2018/644 of the European Parliament and of the Council , and any other postal services or freight transport services;
- (14)‘distributor’ means any natural or legal person in the supply chain who makes a product available on the market, other than the manufacturer or importer of that product;
- (15)‘economic operator’ means a manufacturer of a product or component, a provider of a related service, an authorised representative, an importer, a fulfilment service provider or a distributor;
- (16)‘online platform’ means online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;
- (17)‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;
- (18)‘substantial modification’ means a modification of a product after it has been placed on the market or put into service:
(a)
that is considered substantial under relevant Union or national rules on product safety; or(b)
where relevant Union or national rules on product safety lay down no threshold on what is to be considered a substantial modification, that:(i)changes the product’s original performance, purpose or type, without that change having been foreseen in the manufacturer’s initial risk assessment; and(ii)changes the nature of the hazard, creates a new hazard or increases the level of risk.
Relevant Recitals for this Article
In order to ensure that the Union’s product liability regime is comprehensive, no-fault liability for defective products should apply to all movables, including software, including when they are integrated into other movables or installed in immovables.
Decision No 768/2008/EC of the European Parliament and of the Council lays down common principles and reference provisions intended to apply in all sectoral product legislation. In order to ensure consistency with that Decision, certain provisions of this Directive, in particular the definitions, should be aligned therewith.
Products in the digital age can be tangible or intangible. Software, such as operating systems, firmware, computer programs, applications or AI systems, is increasingly common on the market and plays an increasingly important role for product safety. Software is capable of being placed on the market as a standalone product or can subsequently be integrated into other products as a component, and it is capable of causing damage through its execution. In the interest of legal certainty, it should be clarified in this Directive that software is a product for the purposes of applying no-fault liability, irrespective of the mode of its supply or usage, and therefore irrespective of whether the software is stored on a device, accessed through a communication network or cloud technologies, or supplied through a software-as-a-service model. Information is not, however, to be considered a product, and product liability rules should therefore not apply to the content of digital files, such as media files or e-books or the mere source code of software. A developer or producer of software, including AI system providers within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council , should be treated as a manufacturer.
Whereas digital files as such are not products within the scope of this Directive, digital manufacturing files, which contain the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools, such as drills, lathes, mills and 3D printers, should be considered to be products in order to ensure the protection of natural persons in cases where such files are defective. For example, a defective computer-assisted-design file used to create a 3D-printed good that causes harm should give rise to liability under this Directive, where such a file is developed or supplied in the course of a commercial activity. For the avoidance of doubt, it should be clarified that raw materials, such as gas and water, and electricity are products.
It is becoming increasingly common for digital services to be 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. While this Directive should not apply to services as such, it is necessary to extend no-fault liability to such integrated or inter-connected digital services as they determine the safety of the product just as much as physical or digital components. Those related services should be considered components of the product into which they are integrated or with which they are inter-connected where they are within the control of the manufacturer of that product. Examples of related services include the continuous supply of traffic data in a navigation system, a health monitoring service that relies on a physical product’s sensors to track the user’s physical activity or health metrics, a temperature control service that monitors and regulates the temperature of a smart fridge, or a voice-assistant service that allows one or more products to be controlled by using voice commands. Internet access services should not be treated as related services, since they cannot be considered as part of a product within a manufacturer’s control and it would be unreasonable to make manufacturers liable for damage caused by shortcomings in internet access services. Nevertheless, a product that relies on internet access services and fails to maintain safety in the event of a loss of connectivity could be found to be defective under this Directive.
Related services and other components, including software updates and upgrades, should be considered to be within the manufacturer’s control where they are integrated into, or inter-connected with, a product, or supplied, by the manufacturer or where the manufacturer authorises or consents to their integration, inter-connection or supply by a third party, for example where the manufacturer of a smart home appliance consents to the provision by a third party of software updates for the manufacturer’s appliance or where a manufacturer presents a related service or component as part of the product even though it is supplied by a third party. A manufacturer should not be considered to have consented to integration or inter-connection merely by providing for the technical possibility of integration or inter-connection or by recommending certain brands or by not prohibiting potential related services or components.
Once a product has been placed on the market, it should be considered to remain within the manufacturer’s control where the manufacturer retains the ability to supply software updates or upgrades itself or via a third party.
This Directive should apply to products placed on the market or, where relevant, put into service in the course of a commercial activity, whether in return for payment or free of charge, for example products supplied in the context of a sponsoring campaign or products manufactured for the provision of a service financed by public funds, since that mode of supply nonetheless has an economic or business character. The concept of ‘putting into service’ is relevant for products that are not placed on the market prior to their first use, as can be the case for lifts, machinery or medical devices.
In so far as national law so provides, the right to compensation for injured persons should apply both to direct victims, who suffer damage directly caused by a defective product, and to indirect victims, who suffer damage as a result of the direct victim’s damage.