Five gaps between the AI Act high-risk criteria and our MDR QMS
This story is from 2026-10-17. It is preserved in the archive; the latest stories are on the live feed.
A SaMD manufacturer pinged me last week asking whether the AI Act's high-risk classification overlapped with their existing MDR Class IIa SaMD. The short answer is yes. The longer answer is that the overlap is messier than the Commission guidance suggests, and the gaps between the two frameworks ar…
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- 2026-10-17 11:42 · DEV Community — AI
Five gaps between the AI Act high-risk criteria and our MDR QMS