Article intro - white paper on Surgical Robot Certification
TÜV SÜD created a pretty comprehensive guide on "Surgical robotics Global market entry opportunities and challenges" that you can access as a white paper. Abstract Robotic systems fall under the scope of the European Union’s Medical Device Regulation and as artificial intelligence becomes a core functional component, they will also become subject to the emerging Artificial Intelligence Act. Manufacturers must successfully navigate the complex lifecycle of robotic systems and the regulatory environment, from design and validation to market access and ongoing performance monitoring. However, a lack of standardised benchmarks for real-world performance, combined with variability in national regulatory interpretations, further complicates global market entry. This white paper explores how the future of surgical robotics depends on integrated technical, clinical and ethical frameworks. It also discusses the need for independent validation, evidence-based assessment and cros...
