Area 9: Regulatory affairs & medical devices

• AI Act for medical devices delayed to August 2028: more time, same work
  02 Oct 2026Regulatory affairs & medical devices
  The Digital Omnibus pushes the high-risk obligations for AI in medical devices back by a year. Notified bodies warn of a bottleneck.
• AI in regulatory work: grounded in sources, not a text generator
  02 Oct 2026Regulatory affairs & medical devices
  Two research papers show how AI can support safety documentation and classification without sacrificing traceability. Still at concept stage, but a useful principle.
• Generative AI medical devices: FDA asks for feedback by 19 October
  02 Oct 2026Regulatory affairs & medical devices
  FDA outlines a competency-based assessment for medical devices that use generative AI. Not a requirement yet, but a clear signal of what manufacturers should prepare for.
• FDA: radiology AI still needs a 510(k), including follow-on devices
  02 Oct 2026Regulatory affairs & medical devices
  FDA has denied a partial exemption for radiology CAD and triage software. What manufacturers should now build into their submission planning.
• New standards for AI: EN 18286 and ISO/TS 24971-2 are out, presumption of conformity is not
  02 Oct 2026Regulatory affairs & medical devices
  A European QMS standard for the AI Act and an ISO guide to risk management for machine learning. What they cover and where the gap remains.