Physical AI and robotics in life sciences: Navigating the regulatory landscape

Physical AI is moving into operating theatres, care settings and investment portfolios. Is your legal and regulatory strategy keeping pace?

For AI-enabled medical devices, surgical robots and assistive technologies, the challenge goes beyond technical performance. Regulatory classification, compliance obligations and liability exposure can shape the route to market — and the investment case.

Our experts will tackle the questions that matter:

• Which rules apply? How the AI Act and MDR interact — and what proposed Digital Omnibus changes could mean for your planning
• When is Physical AI classified as high-risk? Why the answer matters for product development, compliance and market access
• Who bears the liability? How the revised EU Product Liability Directive changes the risk landscape for AI-enabled products
• Can your documentation withstand scrutiny? Why compliance records matter not only to regulators, but also in litigation and due diligence.