Keywords: Medical devices, product liability, European Product Liability Directive
Abstract: This article analyzes product liability for medical devices in light of the revised EU Product Liability Directive (2024/2853) and its relevance for Switzerland. It highlights key changes compared to existing Swiss law, including the expansion of liable operators and the inclusion of software and AI-based systems as products. Particular attention is given to the Directive’s stricter safety standards and its claimant-friendly procedural rules, notably disclosure duties and evidentiary presumptions. The article assesses the resulting liability risks for manufacturers and other economic operators in the medical device sector. It concludes that Swiss manufacturers and other economic operators will need to adapt to the EU regime in practice, despite its lack of direct applicability in Switzerland.
I. Introduction
Product liability for medical devices exists in a field of tension between promoting innovation and regulatory control. While innovative medical devices open up new treatment possibilities, they present manufacturers and distributors with significant liability challenges. The legal frameworks governing product liability in Switzerland and the EU are currently still comparable, as the Swiss Product Liability Act (PLA) is based on the original EU Product Liability Directive (85/374/EEC) of 1985. However, this may change in the future.
The revised EU Product Liability Directive (2024/2853; “Directive”), which entered into force on 8 December 2024, goes considerably further than current Swiss law in several respects. It expands the circle of liable persons (e.g., to fulfillment service providers and online platform operators), extends the scope of covered products (e.g., to software), and tightens product safety requirements. It also introduces far-reaching disclosure obligations and evidentiary presumptions for injured persons, substantially strengthening their position in liability proceedings.
While Switzerland has so far maintained its established but less extensive liability regime, Swiss medical device manufacturers – not least due to their close economic ties with the EU – will increasingly need to engage with the stricter European requirements. It is also to be expected that Switzerland will eventually incorporate these stricter rules into its own law.
II. Bases of Liability
When a medical device causes harm, an injured party may in principle claim damages under Swiss law on the basis of: (i) a contractual basis (if one exists), (ii) non-contractual tort law (Art. 41 et seq. Swiss Code of Obligations), and (iii) the Product Liability Act (“PLA”). A contractual basis is often absent, as an intermediary (e.g., a hospital or physician) typically stands between the manufacturer and the patient. Despite recent changes to the statute of limitations under tort law, the PLAremains the preferred basis for claims, primarily because it requires no proof of fault or wrongfulness – but “only” a product defect. This position is likely to be reinforced as EU developments influence Swiss law, given the expanded scope of the revised EU Product Liability Directive in terms of covered products, liable parties, and evidentiary relief.
III. Substantive Aspects of the New Rules
A. Liable Parties
Under the PLA, the primarily liable party is the manufacturer (Art. 1(1) PLA). A “manufacturer” includes: (a) the producer of the final product, a raw material, or a component; (b) any person who presents themselves as a manufacturer by affixing their name, trademark, or other identifying mark (the so-called quasi-manufacturer); and (c) any importer who places a product on the market in the course of their business. Where the manufacturer cannot be identified, the supplier is treated as the manufacturer unless they identify the manufacturer within a reasonable period.
A particular feature of medical device law is that foreign manufacturers without a registered office in Switzerland must appoint an authorized representative (CH-REP) pursuant to Art. 51(1) Medical Device Ordinance. Depending on the circumstances, the CH-REP may qualify as a manufacturer under the PLA, and even where the CH-REP does not import products, Art. 47d(2) of the Therapeutic Products Act (TPA)imposes joint and several liability with the manufacturer.
The revised EU Product Liability Directive (Art. 8) expands the circle of liable “economic operators” beyond those recognized under the PLA. In addition to the manufacturer, component manufacturer, quasi-manufacturer, importer, and authorized representative, the Directive now also includes fulfillment service providers and, under certain conditions, online platform operators. Furthermore, a person who substantially modifies a product outside the manufacturer’s control and then places it on the market may also be treated as a manufacturer.
B. Definition of Product
Under the PLA, a “product” means any movable item (including components of other items) and electricity. While the Swiss Federal Supreme Court confirmed that non-consumer goods such as hip prostheses fall within the scope of the PLA, it remains disputed whether standalone software (such as medical apps) or AI-based applications are covered under existing Swiss law.
The revised EU Product Liability Directive significantly expands the product concept to include software, digital manufacturing files, and raw materials. Digital manufacturing files – such as a defective file used for 3D printing that causes damage – are expressly covered.
The Directive also covers “components”, including “related services” – digital services so integrated into a product that the product cannot function without them. This draws service providers and data suppliers into the circle of potentially liable parties, which is particularly significant for providers of AI training data.
The Directive maintains a technology-neutral approach and covers all forms of software and AI systems, including standalone AI systems and AI components integrated into products. An exception applies to open-source software provided non-commercially; however, where such software is subsequently integrated into a product by a commercial manufacturer, that manufacturer may still be held liable for resulting defects.
C. Definition of Defect
A product is defective if it fails to provide the safety that a person is legitimately entitled to expect, having regard to all the circumstances, including how the product is presented, its reasonably foreseeable use, and the time it was placed on the market. Safety expectations are assessed objectively. For medical products prescribed or applied by a physician, courts have held that the legitimate safety expectations are not determined solely by the patient. The Federal Supreme Court held in the “Yasmin”-case that for prescription drugs, the physician’s expectations are decisive, while the Bern Court of Appeal took an intermediate approach in a 2021 hip prosthesis case, considering the average patient’s expectations in light ofthe surgeon’s expertise.
Labeling and instructions for use play a crucial role in defining the safety standard, though a list of risks and side effects does not automatically exclude liability. Post-market events – including field safety corrective actions (FSCAs) and product recalls – may be relevant to establishing whether legitimate safety expectations were met at the time of placing the product on the market.
The revised EU Product Liability Directive (Art. 7) adds numerous new circumstances to be considered when assessing defectiveness, including: the product’s ability to learn or acquire new functions after being placed on the market; reasonably foreseeable interactions with other products; cybersecurity requirements; product recalls and regulatory interventions; the specific needs of the target user group; and, for preventive products, failure to achieve that preventive purpose. For high-risk products such as life-sustaining medical devices, courts may find a product defective without proof of actual defect if it belongs to the same production series as a demonstrably defective product – codifying the ECJ’s 2015 pacemaker ruling.
These changes are expected to raise safety expectations and increase the number of successful product liability claims involving medical devices.
IV. Procedural Aspects
A. New Disclosure Obligations
The most significant novelties under the revised EU Product Liability Directive lie in the area of procedure and evidence. Art. 9 requires courts to order manufacturers to disclose relevant evidence, provided the injured party has presented facts and evidence sufficiently supporting the plausibility of their claim. This introduces a form of discovery – a concept foreign to continental European legal systems – and is likely to be particularly significant in the technically complex field of medical devices.
Manufacturers may even be required to produce documents in an accessible and comprehensible form – including summaries of technical documentation. Also in this respect, manufacturers of medical devices are particularly affected, as these products are technically and scientifically complex and their functioning may not be easily understandable by laypersons. These extensive disclosure obligations may incentivize manufacturers to settle in order to avoid both the associated burden and the risk of disclosing trade secrets.
B. Evidentiary Presumptions
While the injured party must in principle prove defectiveness, damage, and causation, the revised Directive introduces important presumptions. Defectiveness is inter alia presumed where the manufacturer fails to comply with its disclosure obligations, where the product does not meet mandatory safety requirements, or where the damage was caused by an obvious malfunction during foreseeable use. Causation is presumed where defectiveness is established and the type of damage suffered is typically attributable to that type of defect.
In addition, where it remains excessively difficult for the claimant – particularly due to technical or scientific complexity – to prove defectiveness or causation even after disclosure, and where the claimant establishes that defectiveness or causation is probable, the court must presume these elements. As Recital 48 of the Directive shows, the EU legislator wanted to particularly address complex products with these new provisions, such as medical devices, pharmaceuticals, and new technologies.
In the author’s view, these rules – while designed to address the “black box” effect of AI systems – go significantly too far in their general application, as they are likely to amount to a reversal of the burden of proof in many cases.
C. Implications for Switzerland
Although Swiss courts have recognized limited evidentiary relief in product liability cases, the new EU rules go considerably further. Since the revised Directive does not apply in Switzerland, its disclosure obligations and evidentiary presumptions currently have no direct effect under Swiss law. However, given the export-oriented nature of Swiss medical device manufacturers, they will inevitably need to engage with the new EU rules in practice, regardless of whether Switzerland formally adopts them.
V. Special Issues
A. CH-REP Liability and Insurance
The joint and several liability of the Swiss authorized representative under Art. 47d(2) TPA was addressed above. A practical problem that remains largely unresolved is that this liability risk cannot currently be independently insured in Switzerland. Swiss authorized representatives are therefore advised to seek coverage under the foreign manufacturer’s insurance policy.
B. Trade Secret Protection
While Art. 9(4) and (5) of the revised Directive require courts to take into account the protection of confidential information and trade secrets when ordering disclosure, it remains to be seen how national courts will apply these limits in practice. Manufacturers are advised to proactively mark confidential information – includingsource code and AI algorithms – as trade secrets from the outset, and to explore the extent to which legal privilege may protect certain information.
VI. Recommendations for Reducing Liability Risk
Manufacturers, importers, authorized representatives, and other economic operators are advised to familiarize themselves with the new rules and consider the following measures:
• Documentation management: Establish a documentation system that protects confidential information through appropriate marking and secure storage, accommodates the extended 25-year long-stop period (previously 10 years),and ensures long-term readability of records. This will help to have relevant exculpatory evidence available and to comply with disclosure obligations, thereby avoiding evidentiary presumptions.
• Plain language: Where possible, draft documentation in clear, accessible language from the outset.
• Training: Train the relevant teams (e.g., regulatory and R&D) on the new requirements, including lifecycle management and the proper classification of sensitive information.
• Legal review: Have the wording of core product documentation – including instructions for use and marketing materials – reviewed by legal counsel to minimize exposure.
• Insurance: Comprehensively review insurance coverage, particularly with respect to software, AI systems, and other new risk categories, as well as back-to-back indemnification arrangements within the supply chain.
• Legal privilege and regulatory communications: Assess the availability of legal privilege in relevant jurisdictions, and pay heightened attention to the wording of FSCAs, “Dear Doctor”-letters, and similar communications, as these documents will carry increased evidential weight under the new regime.
VII. Summary and Outlook
The age of smart products brings a new dimension to product liability: machines and systems increasingly act autonomously, enabling innovative solutions but also creating new risks. The introduction of stricter liability rules under the revised EU Product Liability Directive is broadly understandable as a means of protecting consumers. However, there is a real danger that overly broad or undifferentiated regulation will stifle innovation and may not be equally appropriate for all product categories. Highly regulated and technically sophisticated products such as medical devices are particularly affected. The central challenge remains to develop a balanced legal framework that promotes both safety and innovation, while appropriately accounting for the characteristics of different product categories.
