Liability for defective product Directive (EU) 2024/2853: what’s new for MD and IVD manufacturers?

On the eve of its 40th anniversary, the Liability for defective product Directive is being renewed to adapt to technological innovations, combat legal inconsistencies and ensure legislative consistency within the EU.  

Published in the Official Journal of the European Union on November 18, 2024, Directive (EU) 2024/2853 on liability for defective products repeals its predecessor, Directive 85/374/EEC.   

The aim? To establish common rules on the liability of economic operators for damage caused to individuals by defective products, and on compensation for such damage.   

It must be transposed into national law within two years.  

Directive (EU) 2024/2853 will apply to products placed on the market or put into service after December 9, 2026.  For products placed on the market or put into service before this date, Directive 85/374/EEC continues to apply.  

Sometimes overlooked, yet essential in the medical device (MD) and in vitro diagnostic medical device (IVD) sectors, product liability can have a significant financial impact for stakeholders, all the more so now that it has been revised.   

Because yes, Directive (EU) 2024/2853, like the one it replaces, does apply to both MD and IVDs.  

The notion of “product” is defined in Article 2 of Directive (EU) 2024/2853 as “all movables, even if integrated into, or inter-connected with”. MDs and IVDs are movables, since they are items that can be moved. As proof of this, they are mentioned in recitals 26, 30 and 48 of the Directive.   

So what are the new features introduced by Directive (EU) 2024/2853 that have an impact on MD and IVDs?

Extension of the scope of persons concerned (Article 8)  

While Directive 85/374/EEC only concerned “producer”, meaning manufacturers of finished products, component parts or raw materials, the list of persons who can be held liable for defective products has now been extended.    

In the case of a manufacturer established outside the Union, and without prejudice to his liability, the authorized representative and the importer may now be held liable in the event of defective products.  

Extension of products concerned (article 4 point 1)  

Directive 85/374/EEC was limited to movable furniture only, which excluded stand-alone software (not integrated into a MD or IVD) and, consequently, artificial intelligence systems.   

This will soon no longer be the case, as Directive (EU) 2024/2853 now covers “software, digital production documents and raw materials”.   

Extended scope of damage (Article 6)  

In addition to death and personal injury, the right to compensation now also applies to :  

• • • personal injury, including medically recognised damage to psychological health   

• • • Intangible damages such as pain and suffering  

• • • destruction or corruption of data that are not used for professional purposes   

This increases the number of possible grounds for legal action.  

New criteria for assessing product defects (article 7)  

The Directive takes into account new criteria for assessing the defectiveness of a product, in particular :  

• • • The ability of the product to continue learning or to acquire new characteristics after it has been placed on the market (this applies in particular to products incorporating an artificial intelligence system).  

• • • The reasonably foreseeable effect on the product of other products used in conjunction with the product (for connected products);  

• • • Applicable cybersecurity requirements.  

Making it easier for applicants to obtain evidence (article 9)  

Rules have been introduced to make it easier for claimants to obtain evidence.  

In particular, the courts will be able to order the accused economic operator to disclose relevant evidence in his possession, if the injured consumer presents sufficient facts and evidence to support the plausibility of his claim for compensation.  

Introduction of presumptions of defectiveness and/or causality (article 10)  

The Directive lightens the burden of proof for the injured consumer by establishing a presumption of defectiveness and a causal link when the latter:   

• • • faces “excessive difficulties, in particular due to technical or scientific complexity, in proving the defectiveness of the product or the causal link between its defectiveness and the damage  

• • • Demonstrates that the existence of the defect and/or the causal link is “probable”.  

This could particularly concern innovative medical devices (product complexity), which the Directive expressly cites as an example in Recital 48.  

Tougher exemption from liability (Article 11)  

Under Directive 85/374/EEC, manufacturers of medical devices or IVDs incorporating software could be exempted from liability in view of the evolving nature of the software (updates), on the grounds that the defect which caused the damage did not exist at the time the product was placed on the market, and that this defect had appeared subsequently (in accordance with Article 7b).   

Directive (EU) 2024/2853 no longer makes exemption from liability possible when a product’s defect is due to one of the following, provided it is under the manufacturer’s control:   

• • • A related service   

• • • Software, including software updates or upgrades  

• • • Lack of software updates or upgrades required to maintain security  

• • • Substantial modification of the product  

 Extension of the limitation period (article 17)  

Victims will have 25 years after the product was marketed to assert their rights, compared with 10 years under the previous system.  

Conclusion : Liability for defective product Directive (EU) 2024/2853: what’s new for MD and IVD manufacturers?  

Directive (EU) 2024/2853 on liability for defective products considerably strengthens the level of consumer protection by facilitating the right to compensation for the injured consumers.  

Economic operators in the MD and IVD sectors need to prepare for this increased liability, and the possible financial impact (increased insurance costs).   

It is essential to take advantage of the 24-month transition period foreseen for by the Directive to work closely with legal experts to understand the functioning of product liability.