{"id":3199,"date":"2026-08-20T17:21:51","date_gmt":"2026-08-20T15:21:51","guid":{"rendered":"https:\/\/www.bayoocare.com\/unkategorisiert\/product-liability-for-medical-devices-an-overview-of-the-new-law\/"},"modified":"2026-08-24T10:36:01","modified_gmt":"2026-08-24T08:36:01","slug":"product-liability-for-medical-devices-an-overview-of-the-new-law","status":"publish","type":"post","link":"https:\/\/www.bayoocare.com\/en\/regulatory-newsletter\/product-liability-for-medical-devices-an-overview-of-the-new-law\/","title":{"rendered":"Product Liability for Medical Devices: An Overview of the New Law"},"content":{"rendered":"

An Overview of the New EU Product Liability Directive<\/h2><\/h2><\/div>

The new Product Liability Directive replaces Directive 85\/374\/EEC and, with it, a liability regime that essentially dates back to a time before software, cloud services, and self-learning algorithms. The basic principle remains unchanged: product liability remains strict liability. An injured party does not have to prove wrongdoing on the part of the manufacturer, but rather the defectiveness of the product, the damage, and the causal link. The framework surrounding these principles has been modernized, and this has a particularly significant impact on medical devices.<\/p>\n

Expanded Definition of \u201cProduct\u201d: According to <\/strong>Article 4 of the EU Product Liability Directive, software, digital manufacturing files, and raw materials are also expressly considered products. For medical devices, this means that standalone software, embedded software, apps, and AI systems fall directly within the scope of the directive\u2014regardless of whether they are provided on a data carrier, as a download, or as a service.<\/p>\n

Expanded Scope of Parties Subject to Liability: <\/strong>In addition to the manufacturer, Article <\/strong>8 lists, among others, component manufacturers, importers, authorized representatives, fulfillment service providers, and\u2014on a subsidiary basis\u2014distributors and online platforms. Anyone who substantially modifies a medical device and subsequently makes it available may also be held liable as a manufacturer.<\/p>\n

Expanded Definition of Damages: <\/strong>Pursuant to Article 6, the following are eligible for compensation <\/strong>: death and bodily injury, including medically recognized mental health impairments; property damage; and the destruction or damage of data that is not used exclusively for professional purposes. The previous deductible of 500 euros for property damage no longer applies, nor does the possibility of a national liability cap.<\/p>\n<\/div>

The New Product Liability Act: Germany’s Implementation<\/h2><\/h2><\/div>

In Germany, the directive is being implemented through the Act on the Modernization of Product Liability Law. This is the first comprehensive reform of the Product Liability Act since 1989 and thus the most significant change to German product liability law that medical device manufacturers have experienced in the past three decades. The government\u2019s draft bill has been available since February 2026 (BT-Drs. 21\/4297); following the first reading in March 2026 and the hearing in the Legal Affairs Committee, the parliamentary process is still ongoing. It must be completed by December 9, 2026.<\/p>\n

In practice, this means that the new Product Liability Act incorporates the provisions of the EU Product Liability Directive but, in several areas, makes use of national discretion\u2014for example, regarding procedural matters, the protection of trade secrets in the context of disclosure, and the determination of compensation for non-pecuniary damages. Manufacturers should therefore closely monitor the final version of the Product Liability Act and not base their processes solely on the text of the directive. However, those who are already planning based on the Directive are not working in a vacuum: the substantive core\u2014the definition of a defect, relaxed standards of proof, disclosure obligations, and time limits\u2014is prescribed by European law and will be reflected in national law.<\/p>\n<\/div>

Medical Device Liability: MDR-Compliant, Yet Still Liable?<\/h2><\/h2><\/div>

Those who have successfully guided their medical device through the conformity assessment process conducted by a Notified Body often believe they are in the clear. This is precisely where the most common misconception regarding medical device liability lies.<\/p>\n

Civil courts determine independently whether a product is defective for purposes of liability law. According to Article 7 of the Directive, the criterion is whether the product provided the level of safety that the general public could reasonably expect, assessed on the basis of a number of circumstances, which expressly include relevant product safety requirements and interventions by competent authorities. MDR compliance and a positive assessment by the Notified Body thus serve as significant evidence in favor of the manufacturer in this evaluation. However, they do not have a binding effect or preclude liability.<\/p>\n

In short, this means that a medical device may have been legally on the market for years but could still be retroactively classified as defective\u2014for example, because the state of science and technology has advanced, because comparable products now offer a higher level of safety, or because a known risk was not consistently minimized. Conformity assessment is a regulatory snapshot in time, not a liability shield.<\/p>\n<\/div>

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Liability Risks Throughout the Entire Product Life Cycle<\/h2><\/h2><\/div>

A key shift in perspective concerns the point in time that matters. Safety is no longer viewed merely as a snapshot at the time of market release, but as an ongoing responsibility throughout the entire product life cycle.<\/p>\n

This is made clear by the liability exemptions in Article 11. The classic defense based on development risk\u2014that the defect was not detectable given the state of science and technology at the time the product was placed on the market\u2014remains in effect in principle. However, it does not apply if the defect is due to a circumstance that remains under the manufacturer\u2019s control: for example, a software update or upgrade, a related service, or an update that was necessary but not provided.<\/p>\n

As a result, inadequate product monitoring, failure to provide safety updates, or risk mitigation measures taken too late can directly give rise to liability. Risk management, post-market surveillance, PMCF, and vigilance\u2014already core obligations under the MDR\u2014are thus coming even more into focus because they now indirectly influence civil liability. Anyone who collects PMS data but fails to analyze it, or identifies trends without taking appropriate action, creates not only a regulatory finding but also a documented liability risk.<\/p>\n<\/div>

Documentation Becomes a Liability Factor<\/h2><\/h2><\/div>
This situation is exacerbated by two procedural changes that, in practice, carry at least as much weight as the substantive changes. Disclosure of Evidence (Art. 9): If <\/strong>an injured party presents <\/strong>facts that make their claim plausible, the court may require the defendant to disclose relevant evidence in a comprehensible and accessible form. This may include technical documentation, risk management files, clinical evaluations, and PMS and vigilance data. This does not imply an obligation to disclose all documentation; the order must be proportionate, and trade secrets must be protected. In practice, however, the negotiating position shifts significantly. Presumptions Regarding Defectiveness and Causation (Art. 10): If <\/strong> the manufacturer fails to comply <\/strong> with a disclosure order, or if the injured party faces excessive difficulty in proving defectiveness or causation due to technical or scientific complexity, the court may presume these facts. These relaxations of the burden of proof amount to a partial reversal of the burden of proof: The presumptions are rebuttable, but the burden of rebuttal then lies with the manufacturer. For manufacturers, this means a shift in focus: Documentation is no longer prepared solely for Notified Bodies and regulatory authorities, but potentially for a court. A traceable, complete, and consistent chain of evidence\u2014from risk analysis through clinical evaluation to PSURs and vigilance reports\u2014thus becomes a central component of the defense strategy. Anyone with gaps in this area risks not only regulatory trouble but also a significantly increased risk of litigation. <\/section>\n<\/div>

Product Liability for Software and AI in Medical Devices<\/h2><\/h2><\/div>

The situation is becoming even more challenging for software- and AI-based medical devices. Product liability for software was controversial under the old law; now it is explicitly regulated. Adaptive algorithms, continuous updates, and a high degree of dependence on data quality simultaneously create sources of error that did not exist under traditional product liability law. Article 7 explicitly lists circumstances characteristic of this product category: the effects of a product\u2019s learning capabilities, the effects of other products on which the product reasonably depends, and relevant cybersecurity requirements.<\/p>\n

In practical terms, this makes the following, among other things, relevant:<\/p>\n