September 17, 2026
LinkedIn Live
Manufacturers of AI-enabled devices are preparing for EU AI Act obligations while the EU MDR itself goes through a simplification process. The standards meant to connect the two are still taking shape. Questions are arriving faster than guidance, so we took them straight to a notified body.
In this LinkedIn Live, RQM+’s Jai Kutty, VP, Cardiovascular Center of Excellence, moderates an audience-driven Q&A with Sandy Wright, Head of Devices at Scarlet, the notified body specializing in AI and software as a medical device (SaMD). Jai is joined by RQM+’s Jon Gimbel, VP of Regulatory Affairs, and Samy Puccio, Director of Regulatory Affairs. Together, this panel answers live questions on how AI medical device submissions are being assessed today.
What’s Covered
- Where the EU MDR and the AI Act meet: Why AI controls belong inside your existing technical file and change control, and why AI Act Articles 9 through 17 show where requirements are heading
- ISO/IEC 42001 and EN 18286: How the two AI standards work together on an ISO 13485 foundation, and why 42001 certification can matter for markets outside the EU and for hospital procurement
- The IMDRF AI life cycle framework: Why the draft International Medical Device Regulators Forum (IMDRF) guidance already helps teams with global market plans find blind spots
- Third-party large language models (LLMs) inside devices: What notified bodies expect for version pinning, software of unknown provenance, and performance metrics beyond word error rate
- When a model update becomes a substantial change: How retraining is treated for Class IIa and IIb software, and why your notified body relationship shapes change notification
- Clinical evidence for clinician-plus-AI performance: How to layer stand-alone accuracy, clinician-with-AI comparisons, retrospective data, and real-world evidence across the device life cycle
- AI in your QMS and submissions: Why fully AI-generated documentation becomes apparent during audits, and when AI tools that run parts of your QMS may need validation and disclosure
- The pitfalls notified bodies flag most: Post-market clinical follow-up (PMCF) plans limited to surveys and complaints, post-market surveillance that misses model drift, and training and test data without enough independence
Who This Is For
Regulatory affairs leaders, QA/RA teams, clinical teams, and software and data science teams at medical device and IVD companies that are developing AI- or ML-enabled devices for the EU market and want a regulatory strategy that holds up under notified body review.
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