SAFETY COMPONENT definition in medical device regulation?

[Al2772]

Hello everyone!
Now I am currently searching concerning interplay of MDR/IVDR and the EU AI Act.

Mostly of MDSW with AI seems to fall under the definition of High-risk AI System, however, this is not truly or completely easy to see due to the lack of clarification of the definition of safety component through the MDR lenses.

Safety component in the AIA states as follows:
‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property;

From your point of view, when an AI-enabled Medical Device, or "component" within it, can fulfill this definition?

Please share your thoughts in this new & blurry regulatory path for AIMD in EU.
Thanks!

 

[yodon]

A bit late, but since no responses yet, maybe this will kick start things.

Are you asking if AI can be a safety component? I'd say unquestionably yes. AI systems have many such uses. IVDs jump to mind (the AI aspect continually learning about positive / negative). Imaging systems identifying areas of interest would be in there. Maybe there's an AI system on something like a large MRI system that identifies humans in areas that need to be avoided during the process.

This should fall out through risk analysis. If any of the AI system implements risk controls, I think that would qualify it as a safety component.