AI Regulation and medical devices: balancing safety and innovation

AI-based medical devices support modern healthcare in many areas and automate routine tasks. They reduce the workload on specialist staff, enable more accurate diagnoses and improve patient care. However, their development and market launch are subject to strict regulatory requirements. With the AI Act, which has been in force since 2024, additional requirements for the introduction and use of AI have been added to the existing Medical Devices Regulation (MDR). This poses considerable challenges for the German medical technology industry, which is predominantly made up of small and medium-sized enterprises, and for start-ups. The current impulse paper from Plattform Lernende Systeme outlines the key requirements of the AI regulations for medical technology, highlights their implications and explores the question of how patient safety and the promotion of innovation can be reconciled.

Small and medium-sized enterprises (SMEs) account for 93 per cent of the German medical technology industry. Recent company surveys in individual sectors of the medical technology industry show that the majority of the companies surveyed are already experiencing problems in implementing regulatory requirements. The main reasons cited are the high costs and bureaucratic burden, for example for adapting technical documentation. While large companies usually have specialised departments to implement complex regulatory requirements, smaller companies often lack the personnel capacity and expertise. This can significantly slow down the development of new, innovative products. For start-ups in the medical technology sector in particular, the AI Regulation exacerbates the existing challenges posed by a lack of regulatory expertise and capital strength.

At the same time, compliance with regulations is essential to ensure the protection of patients when using medical devices. Since most AI-based medical devices are classified as high-risk AI systems, they are subject to the most stringent requirements of the AI Act. This includes, among other things, extended obligations regarding technical documentation, data governance and human oversight. In this area of tension, the central question for the industry is: How can innovation and regulation be reconciled?

Finding a balance between security and innovation

‘Start-ups in the field of medical technology that rely on AI should build alliances and expertise in order to jointly meet the requirements of the AI Regulation and the MDR. Many things are easier when done together,’ says Matthieu-P. Schapranow, Hasso Plattner Institute for Digital Engineering gGmbH and member of Plattform Lernende Systeme.

Clear and coordinated procedures are needed to combine innovation and safety. This includes synchronising the requirements of the MDR and AI Regulation, transparent definitions of key terms, and innovation-friendly framework conditions, especially for SMEs and start-ups.  Real-world laboratories and sandbox projects can also help to test innovative AI systems under real-world conditions and bring them to market more quickly. In future, technological advances in AI should also be harnessed through innovative medical devices, for example through continuously learning AI systems in the healthcare sector.

Access to high-quality health data is also a crucial basis for innovation. The authors of the impulse paper point out that initiatives such as the European Health Data Space (EHDS) should be continued and expanded in order to enable the development and training of powerful AI models in the healthcare sector in Europe and to ensure competitiveness. If regulatory requirements are implemented efficiently and companies are supported at an early stage, the medical technology industry can maintain its innovative strength while ensuring a high level of patient safety.

‘It is of central importance for Europe to actively promote AI-based medical devices. Only in this way can we achieve and secure clinical value for patients, our European standards and our position as a business location in international competition,’ emphasises Björn Heismann, Siemens Healthineers AG and member of Plattform Lernende Systeme.

About the impulse paper

The impulse paper "AI Regulations: Their Impact on Medical Devices. Challenges and Open Questions" was written by members of the "Health Care, Medical Technology, Care" working group of Plattform Lernende Systeme. It is available for download free of charge.