Medical devices

​MD7: Updates on Artificial Intelligence legislation and policy

By 2025-11-18T10:07:00

MD7 session delegates

 Key points: 

  • The EU Artificial Intelligence (AI) Act will apply from August 2027, but implementation challenges remain due to delays in standardisation and overlap with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) frameworks 
  • Manufacturers may need to establish distinct quality management systems (QMS) structures to meet AI Act requirements, with harmonised standards expected only by mid‑2026 

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