Damages from Medical Devices: Greater Protection for Users

The European regulatory framework concerning liability for damage caused by defective products has undergone a substantial revision with the entry into force of Directive (EU) 2024/2853 ("Directive" or "new PLD"), which replaces the previous Directive 85/374/EEC.

The changes introduced by the new PLD, applicable to products placed on the market after 9 December 2026, are particularly significant for the medical devices sector, where technological innovation and digitalisation present new challenges in terms of safety and user protection.

In this context, the new PLD strengthens protection for injured parties and redefines the rules regarding the burden of proof and the acquisition of evidence, with significant effects for all actors in the supply chain.

Redefinition of "product" and extension of liability within the supply chain

Unlike the previous legislation, which focused on tangible goods and electricity, the Directive adapts to an increasingly digitalised and interconnected market, in which the safety of software and data is an integral part of the overall safety of the product.

The new PLD extends the notion of "product" to include, in addition to traditional tangible goods, software, digital files intended for automated production, and digital services integrated with or connected to the product. For manufacturers of medical devices, this means that liability also extends to software, artificial intelligence applications, monitoring systems, and digital services that contribute to the functioning and safety of the device.

Another innovation is liability for damage resulting from the loss or corruption of data not used for professional purposes, a particularly important aspect for devices that process sensitive patient data.

Liability is no longer limited to the manufacturer alone: the Directive also involves importers, authorised representatives, logistics operators and, in the absence of other identifiable parties, distributors and online platforms that present the product as their own. This element is fundamental for medical devices, which are often produced or assembled outside the Union and distributed via digital channels, ensuring greater protection for the injured party and requiring operators to manage contractual relationships and responsibilities more carefully.

Presumptions and simplification of evidence

Among the most significant innovations of the new PLD are the presumptions, designed to overcome the difficulties that the injured party may encounter in proving the defect, especially in the case of complex products such as medical devices.

The court must presume the defect of the product in the occurrence of one of the following situations:

• the defendant does not provide the evidence requested by the injured party;
• the injured party demonstrates that the product does not comply with mandatory safety requirements provided by European or national legislation;
• the damage results from an obvious malfunction of the product during reasonably foreseeable use or under ordinary conditions.

These presumptions represent an important easing of the burden of proof for the injured party, who is often at a disadvantage compared to the manufacturer, especially in the case of technologically advanced medical devices.

With regard to the causal link, the Directive provides that it may be presumed when it is proven that the product is defective and that the type of damage is compatible with such defect.

A further innovation concerns cases in which the injured party faces "excessive difficulties", particularly due to the technical or scientific complexity of the product. In these circumstances, the court may presume the defect or the causal link, or both, if the injured party demonstrates that the defect is "likely" or that a causal link exists. This mechanism is expected to be applied, in particular, to innovative medical devices, such as those based on artificial intelligence, where understanding the internal functioning may be complex even for professionals.

Although the defendant may always challenge the presumptions, it is clear that the new PLD creates a more favourable context for the injured party.

New tools for the acquisition of evidence and protection of trade secrets

The new PLD introduces a harmonised system for the acquisition of evidence, marking a clear break with the past.

In particular, it is provided that, at the request of the injured party who has provided sufficient elements to make the claim plausible, the defendant must produce all relevant documents and information in their possession, including technical data, safety reports, and any element useful to demonstrate the defect or the causal link.

This power is, however, balanced by the principle of proportionality: disclosure must be limited to what is strictly necessary for the resolution of the dispute, avoiding excessively broad or irrelevant requests.

The Directive also protects the interests of the defendant, providing that, where disclosure concerns trade secrets, the court may adopt specific measures to ensure confidentiality, such as limiting access to documents or hearings or preparing redacted versions of documents.

In the presence of particularly complex evidence (for example, AI algorithms or clinical data), the court may order that the evidence be presented in an easily accessible and comprehensible manner, if this is proportionate to the costs and effort required of the party.

Not only the injured party, but also the defendant may request the disclosure of evidence held by the claimant, if they demonstrate the necessity of such elements to defend against the compensation claim.

These provisions are particularly important for the medical devices sector, where technical documentation and performance data are often exclusively available to the manufacturer.

Updates, modifications and post-sale liability

The Directive recognises that many products, including medical devices, may be subject to modifications or updates after being placed on the market, for example through software updates or maintenance interventions.

If the modification is substantial and occurs outside the control of the original manufacturer, the party making the modification assumes liability as the new manufacturer. If, on the other hand, the modification occurs under the control of the manufacturer, the latter remains liable also for subsequent defects.

Furthermore, the failure to provide updates or security improvements necessary to maintain the safety of the product, particularly for cybersecurity, may be considered a relevant defect for the purposes of liability. This aspect is fundamental for connected medical devices, which require constant updates to ensure patient safety.

Operational implications for the medical devices sector

The innovations introduced by the new PLD require operators in the sector to review risk management procedures, technical documentation, and contractual relationships throughout the supply chain.

It will be essential to ensure traceability of modifications and software updates, implement systems for managing data and evidence, and carefully assess responsibilities in the case of integration of third-party components or digital services.

Moreover, the greater ease of access to evidence and the presumptions in favour of the injured party could lead to an increase in litigation, making a compliance strategy and proactive management of product safety indispensable.

The extension of liability to digital services and data also requires closer collaboration between manufacturers, software developers, distributors, and digital service providers.

This article, authored by Mauro Teresi, was originally published (in Italian) in AboutPharma and is reproduced here with permission.