Artificial intelligence is one of the key technological drivers in the medical robotics market. It offers high potential for new and further developments in the fields of diagnostics, surgery, laboratories and rehabilitation/therapy. The various market segments are very specific in terms of their supplier structure, the market maturity of robotic systems and the role of AI. Surgical robotics is the most advanced field of application, while robot-assisted diagnostics is in an early phase, highly driven by AI. Laboratory robotics focusing on logistical applications , is similar to industrial use, and rehabilitation/ therapy can be seen as a niche segment. Overall, the robotics systems currently in use are characterised by a relatively low degree of autonomy, supporting humans in their activities and providing decision-making assistance.
The market for medical robotics is already strictly regulated and is largely subject to the Medical Device Regulation (MDR) adopted in 2017. It was implemented with a delay and is currently being revised.
With the AI Act passed in May 2024, companies in all industries must adapt to new regulatory requirements that are perceived as complex and still need to be further specified. This applies in particular to medical robotics, as it is likely to be classified predominantly as high-risk AI. There are currently still numerous unresolved issues regarding the inter-play between the requirements of the AI Regulation and the MDR, which must be met simultaneously.
As a uniform legal framework, the AI Regulation offers the opportunity to strengthen confidence in safe AI systems if implemented successfully. This is particularly important for the acceptance of AI-based medical devices and can strengthen the competitiveness of European medical technology manufacturers through scaling opportunities.
However, this vision requires, in particular, the creation of legal certainty, clarity and uniformity, while avoiding inefficient structures and inappropriate bureaucratic burden, as well as support through innovation-friendly concepts.
The AI Act is still open to change with a postponed timetable and simpler requirements being discussed in the context of the Digital Omnibus which is proposing amendments to the EU's digital regulatory framework as part of a broader simplification and competitiveness initiative.
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Artificial intelligence in medical robotics – regulatory challenges from the AI Regulation (No. 535)
How will the AI Act interact with the existing medical device regulation?
AI offers potential for important innovations in medical robotics, with varying relevance across different fields of application. While the AI Regulation has created a framework for developing safe AI systems, its implementation however is challenging for providers and users in the heavily regulated medical sector.
