The new EU Product Liability Directive 2024/2853

Extensive legal changes on the horizon

On November 18, 2024, the long-awaited Product Liability Directive 2024/2853 was published in the Official Journal Part L. The long title is:

Directive (EU) 2024/2853 of the European Parliament and of the Council of October 23, 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Text with EEA relevance).

The Directive must be transposed into national law by the Member States by December 9, 2026 and the new provisions must be applied from this date. On this date, the previous Directive 85/374/EEC will be repealed.

There are 64 recitals on 11 pages, which are well worth reading in order to better understand the background to the new version of EU product liability law. The operative part of the directive is 11 pages long.

This directive applies to all products placed on the market after December 9, 2026. It does not apply to free and open source software that is developed or made available outside of a business activity.

It is important in the context of harmonization - unless this Directive provides otherwise (see Article 18 regarding development risks) - that Member States neither maintain nor introduce national law that deviates from the provisions of this Directive. This also applies to more stringent or less stringent provisions to achieve a different level of protection for consumers and other natural persons.

A product is any movable item, even if it is integrated into or connected to another movable or immovable item: it also includes electricity, digital design documents, raw materials and software (Art. 4 No. 1). The bolded terms have been added.

The new legal term "control of the manufacturer" is of great importance. This refers to the fact that

  1. the manufacturer of a product performs the following actions or - in the case of actions by third parties - authorizes or consents to them:
    1. the integration, connection or provision of a component, including software updates or upgrades; or
    2. the modification of the product, including substantial modifications;
  2. the manufacturer of a product is in a position to provide software updates or upgrades itself or to have them provided by a third party.

The exclusions of liability pursuant to Art. 11 (1) are important in this context. For this purpose, the respective economic operator concerned must prove one of the circumstances listed in letters a) to g) in paragraph 1 in order to avoid a claim for liability by an injured party.

By way of derogation from point (c) of paragraph 1 ("the probability of the defectiveness which caused the damage not having existed at the time when the product was placed on the market, put into service or, in the case of a supplier, made available on the market, or that such defectiveness arose after that time"), no exclusion of liability may be invoked if the defectiveness of a product is due to one of the following causes, provided that it is under the control of the manufacturer:

  1. an associated service,
  2. software, including software updates or upgrades,
  3. a lack of software updates or upgrades required to maintain safety,
  4. a material change to the product.

The next important point in connection with an exclusion of liability is development risks (Art. 18). By way of derogation from Article 11(1)(e) ("defectiveness could not have been detected by the objective state of the art at the time the product was placed on the market or put into service or during the period when the product was under the control of the manufacturer"), Member States may maintain existing measures in their national legal systems, according to which an economic operator is liable even if he proves that the defect could not have been detected according to the objective state of the art at the time the product was placed on the market or put into service or during the period when the product was under the control of the manufacturer.

Similarly, Member States may adopt or amend measures in their legal systems whereby an economic operator is liable even if he proves that the defect could not have been detected according to the objective state of the art at the time the product was placed on the market or put into service or during the period when the product was under the control of the manufacturer.

According to Art. 18 (3), these provisions must be

  1. limited to certain categories of products,
  2. justified by objectives in the public interest and
  3. be proportionate in so far as they are appropriate to enable the achievement of the objectives pursued and do not go beyond what is necessary to achieve those objectives.

These national provisions must be notified to the Commission in accordance with Art. 18 (4). Therin, the reasons for the measure and the extent to which it is compatible with Art. 18 (3). must be stated.

The significance of the definition of manufacturer (Art. 4 No. 10), which has been amended compared to the previous directive, should not be underestimated:

A manufacturer is any natural or legal person who

  1. develops, manufactures or produces a product,
  2. designs a product or has a product designed or manufactured, or acts as a producer by affixing its name, trademark or other distinctive sign to that product, or
  3. develops, manufactures or produces a product for its own use;

Specifically, the economic operators "authorized representative, importer, supplier and fulfilment service provider" have been added. These economic operators can be held liable with this new legal provision in the case of a non-EU manufacturer with Art. 8 (1) letter c).

A component manufacturer can also be held liable under Art. 8 (1) (b) Manufacturer for a defective component if this component was integrated into or connected to a product under the manufacturer's control and caused the defectiveness of this product.

Where neither the manufacturer nor any other economic operator referred to above can be identified, any supplier of a defective product shall be liable if

  1. the injured person requests the supplier to identify an economic operator referred to in paragraph 1 established in the Union or his own supplier who supplied him with that product, and
  2. that supplier does not designate an economic operator or its own supplier referred to in point (a) within one month of receipt of the request referred to in point (a).

It will certainly be interesting to see how the 27 Member States implement this new directive. It is completely unclear to what extent the UK will adopt this directive.

It is clear that the new product liability legislation contains a number of tightening measures that make the implementation of a Product Compliance Management System (PCMS) essential.

If you would like an initial discussion or in-house training on this topic, please contact the author.

 

Author

Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist

 




DEFINITIONS AND ABBREVIATIONS

EEA: The European Economic Area

 

Published on 04.12.2024
Category: Focus Industry, Focus Consumer Goods & Retail, Fokus Electrical and Wireless, Fokus Medical Devices, Fokus Third Party, Insider-Compliance, Compliance

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