- Leading IEC SC62 D JWG 36 and support IEC SC62A JWG 9 as an expert
Beyond the immediate outputs of the funded activity, the standardisation work on IEC 80601‑2‑78 Ed.2 and IEC TS 80601-4-1 is expected to generate several medium‑ to long‑term societal, economic, and technological impacts.
First, medical robots for rehabilitation are regulated under the European Medical Device Regulation (MDR), which is internationally perceived as complex and difficult to navigate. While the European Commission is currently exploring options for simplification, the timeline and scope of such changes remain uncertain. For European manufacturers—many of which are small and medium‑sized enterprises—the availability of clear, up‑to‑date, and internationally aligned standards is therefore essential. A well‑defined and technically robust standard helps ensure that regulatory requirements remain predictable and do not create additional barriers to market entry.
In the medium term, IEC 80601‑2‑78 Ed.2 will serve as the basis for a corresponding European standard that can be harmonised under the MDR. This will support European SMEs by providing a recognised and authoritative framework for demonstrating conformity. As a result, companies can reduce the time and cost associated with regulatory approval, improve the quality and consistency of their technical documentation, and accelerate their access to the European market.
In the longer term, the standard is expected to contribute to broader economic and technological impacts. A clear and internationally accepted definition of RACA robots, updated safety requirements, and improved guidance on autonomy, cybersecurity, and battery safety will strengthen interoperability and comparability across products. This reduces fragmentation in the European market and supports innovation by giving SMEs a stable foundation on which to develop new robotic solutions. It also helps ensure that European manufacturers remain competitive in a global market increasingly shaped by robotics and automation.
Societal, Economic or Technological Impacts
Beyond the immediate outputs of the funded activity, the standardisation work on IEC 80601‑2‑78 Ed.2 and IEC TS 80601-4-1 is expected to generate several medium‑ to long‑term societal, economic, and technological impacts.
First, medical robots for rehabilitation are regulated under the European Medical Device Regulation (MDR), which is internationally perceived as complex and difficult to navigate. While the European Commission is currently exploring options for simplification, the timeline and scope of such changes remain uncertain. For European manufacturers—many of which are small and medium‑sized enterprises—the availability of clear, up‑to‑date, and internationally aligned standards is therefore essential. A well‑defined and technically robust standard helps ensure that regulatory requirements remain predictable and do not create additional barriers to market entry.
In the medium term, IEC 80601‑2‑78 Ed.2 will serve as the basis for a corresponding European standard that can be harmonised under the MDR. This will support European SMEs by providing a recognised and authoritative framework for demonstrating conformity. As a result, companies can reduce the time and cost associated with regulatory approval, improve the quality and consistency of their technical documentation, and accelerate their access to the European market.
In the longer term, the standard is expected to contribute to broader economic and technological impacts. A clear and internationally accepted definition of RACA robots, updated safety requirements, and improved guidance on autonomy, cybersecurity, and battery safety will strengthen interoperability and comparability across products. This reduces fragmentation in the European market and supports innovation by giving SMEs a stable foundation on which to develop new robotic solutions. It also helps ensure that European manufacturers remain competitive in a global market increasingly shaped by robotics and automation.
Role: convenor
Title & Organisation Name: Congenius AG
Country: Switzerland
