The EU AI Act and new Product Liability Directive is introducing comprehensive regulations that will aim to ensure companies Worldwide that develop, or leverage AI technologies are safe, transparent, and accountable. The Act classifies AI applications based on risk, with stricter requirements for those users which are deemed high risk, such as those in medical devices, diagnostics, and clinical research. If a company is based in the UK, or the US for example, but selling AI-driven products or services into the EU, this will bring them under the directive’s jurisdiction.
The Product Liability Directive, which makes companies liable for damage caused by a defect in their product, will be expanded (for products marketed after December 2026) to include software, specifically AI systems creating new liability risks such as data security breaches, errors in algorithms and biased decision making.
As AI continues to drive innovation in biotech and life sciences, companies will need to place increased emphasis on robust compliance and risk management strategies to navigate these regulatory changes, including ensuring insurance programmes are tailored for AI driven risks. Staying ahead of these shifting standards will be essential for ensuring the safety, effectiveness, and regulatory alignment of AI applications in the life sciences field.