Issue #6 • Oct–Dec 2026

One Device. Two Rulebooks.

Understand how the EU AI Act changes medical device development, certification and post-market surveillance, and how it works alongside MDR and IVDR.

EMD Magazine 2026 cover about the EU AI Act and medical device regulations

What’s covered in this magazine

  • When an AI-enabled medical device becomes high-risk under the EU AI Act

  • How to manage one technical file across the AI Act and MDR/IVDR

  • How to detect and manage AI performance drift after certification

  • What meaningful human oversight actually requires

  • How regulated AI is creating new roles and responsibilities across QA/RA

  • Why AI-generated evidence still requires independent review and traceability

  • What changed with ISO 10993-1:2025 and ISO 10993-6:2026

  • Key updates across EUDAMED, FDA QMSR and UK post-market surveillance

  • A practical Standards Radar covering important ISO, IEC and ASTM updates

  • An interactive regulatory Escape Game: The Algorithm That Changed Overnight

Get Ready for AI-Enabled Medical Device Compliance

Get practical insights to help you connect both regulatory frameworks across development, certification and post-market activities.

EMD Magazine 2026 cover about the EU AI Act and medical device regulations