Life Sciences Horizons Brochure 2025 - Flipbook - Page 65
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2025 Horizons Life Sciences and Health Care
Product liability in the EU for AI-powered medical
devices (continued)
The revised Product Liability Directive (PLD) updates and enhances the EU's legal
framework for product liability, with a particular focus on addressing the challenges
posed by emerging technologies and digital products. In the absence of a specific
liability regime for medical devices, the Medical Device Regulation (MDR) refers to
both EU and national liability laws and thus also to the revised PLD. The revisions
significantly increase liability risks, with notable changes including an expanded
definition of “product” to include digital manufacturing files and software, which
explicitly encompass AI, a broader list of potentially liable parties, and new criteria
for determining product defectiveness, such as interconnectedness and ML capabilities.
Additionally, the revised PLD simplifies the process for injured parties to prove liability
by easing the burden of proof and introducing legal presumptions of defectiveness
and causation, especially if the probability is too complex due to the nature of the
product, as it will be in particular with AI. Given these new rules, future product liability
cases will involve more complicated defenses, and manufacturers will need to be
prepared to provide technical documentation during legal proceedings due to
changes in the evidence requirements.
To navigate this complex regulatory landscape, stakeholders should implement risk
mitigation measures to safeguard against potential liabilities. It is essential to create an
AI governance strategy with clear guidelines for developing, deploying, and monitoring
AI systems to ensure compliance with regulations and ethical standards. AI governance
should encompass continuous monitoring, comprehensive documentation, and secure
data storage. It should also include a robust response plan for potential issues and
ensure regular employee training to maintain adherence to AI regulations and safety
standards. Stakeholders are advised to address liability risks by incorporating clear
contractual clauses that outline their responsibilities and provide safeguards against
disproportionate claims due to unexpected situations. Moreover, securing specialized
insurance early on can safeguard against litigation expenses and liability claims.
Dr. Stefan Mayr, LL.M.
Counsel
Munich
Marc-Philipp Wiesenberg,
LL.M. (Chicago)
Associate
Munich
