New Product Liability Directive (PLD): What is changing?

On 18 November 2024, Directive (EU) 2024/2853 on liability for defective products (new PLD) was published in the Official Journal of the EU. The new PLD, which revises and replaces the nearly 40-year-old Product Liability Directive (Directive 85/374/EEC), aims to modernise the EU’s product liability framework for the digital age while easing the burden of proof for consumers seeking compensation for damages caused by defective products.

Medical devices and in-vitro diagnostic medical devices keep falling into the scope of the new PLD. As such, economic operators involved in their supply chain should carefully assess the new provisions.

No fault-based liability

The new PLD maintains the principle of no-fault liability for defendants regarding damages caused by defective products. This means liability is independent of negligence by the defendant. To obtain compensation, the injured persons must still prove:

• that the product was defective,

• that they suffered damage, and
• that there is a causal link between the defectiveness of the product and the damage suffered.

What changes does the new PLD introduce?

Directive 2024/2853 brings a certain number of notable updates. Key changes are summarised below.

Broader definitions of “product” and “damage”

The new PLD expands the definitions of “product” and “damage”, widening the scope of application of the Directive.

More specifically:

• Broader definition of product: Digital manufacturing files, raw materials and software are also considered products for the purposes of this Directive.
• Broader definition of damage: Harm to psychological health and the loss or corruption of data are now recognized as compensable damages

Liability of Economic Operators

The new PLD broadens the definition of “economic operator”. In that way it guarantees that an EU-based entity can always be held accountable for damages caused by defective products. This approach introduces several additional potential defendants while presenting a clearer hierarchical chain of liability:

• Primary liability:

• Assigned to manufacturers of products or components (including software developers).

According to article 8.2 of the new PLD, whoever substantially modifies a product, outside the control of the original manufacturer, before placing it on the market, is considered to be the manufacturer of that product.

When the manufacturer is based outside the EU, claims can be brought against the:

• importer or
• authorised representative of the manufacturer.

Additional categories of liable parties:

• Fulfilment Service Providers (FSPs): FSPs can be held liable if the manufacturer is based outside the EU and no importer nor EAR is identified.
• Distributors: Distributors may be liable if they fail to identify an EU-based economic operator or their own supplier within one month of an injured party’s request.
• Online platforms: Liability extends to platforms when the average consumer reasonably believes the product is provided by the platform or a controlled user, and no EU-based economic operator is identifiable.

Presumption of defectiveness and causation

Under the new PLD, the burden of proof for the defectiveness of a product and the causal link between the defect and the damage keeps falling on the injured person who is requesting compensation before the court. Nonetheless, the new PLD makes easier to prove that defectiveness and the causal link between the latter and the occurred damage. It does so by introducing a presumption of defectiveness and causation under specific conditions.

Under the new regime, defectiveness is presumed when:

• the manufacturer fails to comply with disclosure obligations,
• the product does not meet mandatory safety requirements, e.g. MDR or IVDR provisions,
• the damage is caused by an obvious product malfunction during reasonably foreseeable use or under ordinary circumstances,
• excessive technical or scientific complexity makes it difficult to prove defectiveness of the product,
• the claimant demonstrates that it is likely that the product is defective.

Moreover, the causal link between defectiveness and damage is presumed when:

• the damage is typically consistent with the alleged defect,
• excessive technical or scientific complexity makes it difficult to prove the causal link between its defectiveness and the damage,
• the claimant demonstrates that it is likely that there is a causal link between the defectiveness of the product and the damage.

Defences available for economic operators

The new PLD retains several existing defences for defendants, such as, among others,:

• the product was not put into circulation by the operator (in the case of manufacturers, importers or distributors),
• the defect could not have been discovered due to the state of technical knowledge at the time the product was on the market or within the manufacturer’s control, or
• the defect did not exist when the product was placed on the market, put into service or, in the case of distributors, made available on the market;

However, this last-mentioned defence does not apply to defects within the manufacturer’s control related to:

1. a related service,
2. software, including updates or upgrades, or
3. the absence of necessary updates or upgrades required to maintain safety.

Additional noteworthy updates in the new PLD include:

• Defect of products after placement on the market: In special cases, an injured person may claim damages also in connection to defects arising after a product is placed on the market. This is mostly related to software updates and upgrades.
• Manufacturer’s obligation to disclose information: In cases where the injured person provides sufficient facts and evidence to support the plausibility of their claim, the defendant must disclose relevant evidence in court.

Implementation Timeline

The Directive will enter into force on 8 December 2024. Member States must transpose it into national law by 9 December 2026.

Do you have any questions on the liability of your medical or in-vitro medical device? Contact us here or send an email to mdlaw@obelis.net.

References

• EUR-Lex (2024). Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC. Retrieved 22/11/2024.
• EUR-Lex (1985). Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. Retrieved 22/11/2024.
• European Parliament (2023). EU Legislation in Progress – New Product Liability Directive (December 2023). Retrieved 22/11/2024.