Impact on SMEs (8th Open Call)
Europe hosts a vibrant ecosystem of start-ups and SMEs developing rehabilitation robots - systems that support relearning functional movement after neurological injury or disease. Under the EU Medical Device Regulation (MDR), manufacturers must demonstrate compliance with the state of the art for safety and performance. For devices within scope, IEC 80601-2-78 has become the key benchmark for basic safety and essential performance of rehabilitation robots. Following publication of the first edition (2019), the joint working group initiated a second edition revision to incorporate early implementation feedback and advances in technology. As this revision progresses toward Committee Draft closure, small manufacturers can expect clearer, more practicable requirements, reducing ambiguity in design inputs, verification planning, and conformity assessment. In parallel, IEC 60601-4-1 (Technical Report) provides a shared framework to characterize and manage degrees of autonomy in medical electrical equipment and systems. current development practices with where general safety requirements are heading.
Overall, these initiatives close critical gaps for European SMEs by clarifying expectations around robotic and AI-enabled rehabilitation devices, helping them accelerate safe market access, contain compliance costs, and remain competitive across EU and global markets.
Impact on society (8th Open Call)
Rehabilitation robotics are among the earliest real-world uses of medical robots and have paved the way for broader adoption of robotics and AI in healthcare and daily living environments with vulnerable users. Clear, harmonised safety requirements and reproducible test methods
are essential - not only to protect patients and clinicians, but also to give manufacturers and providers the confidence to deploy these technologies responsibly. By codifying “state-of the-art” expectations, the standards framework enables innovation while safeguarding users.
Societal benefits enabled by robust standards include:
Patient safety and dignity: Defined limits, fail-safe behaviours, and human–robot interaction requirements reduce the risk of harm and ensure predictable performance in rehabilitation settings.
Healthcare access: Standardised safety/performance criteria help scale high-quality therapy beyond specialised centres, supporting adoption in regional hospitals and community care.
Clinician support and quality of care: Reliable, well-tested systems can deliver high-dose, repeatable training while reducing therapist physical strain, freeing time for complex clinical tasks.
Public trust and uptake: Transparent, consensus-based requirements underpin procurement, reimbursement, and clinical guidelines—building societal confidence in robotic care.
Innovation with accountability: Clear targets shorten development cycles, lower compliance ambiguity for SMEs, and focus competition on outcomes and usability rather than ad-hoc safety interpretations.
The degree-of-autonomy guidance further generalises these protections to any medical product using robotic or AI technologies. By providing a common language for autonomy levels and the associated safety controls and human oversight, it supports ethically aligned, trustworthy deployment of AI-enabled medical devices across care pathways, from clinics to homes.
