More time, but no all-clear! The high-risk requirements of the EU AI Act for “Software as a Medical Device” (SaMD) have been postponed to August 2, 2028, by the “Digital Omnibus on AI” adopted by the EU Council at the end of June 2026. A new deadline also applies to standalone high-risk AI: December 2, 2027.
This gives you some breathing room. Make the most of this extra time! SaMD in Classes IIa through III generally remains high-risk AI under Article 6 of the EU AI Act. The conformity assessment is integrated into the Medical Device Regulation (MDR). If your quality management system (QMS) already reliably complies with the MDR, the question remains: How well does it address the additional AI requirements?
In this concise webinar, Torsten Herbert from sepp.med highlights the 5 gaps where MedTech companies most frequently run into trouble during audits. In 20 minutes, you’ll receive an honest assessment of your current status with specific audit questions for your own organization—and afterward, we’ll answer your questions during the Q&A session.
IT managers and CTOs at medtech companies with AI-based Software as a Medical Device, as well as Regulatory Affairs Managers who coordinate audit preparation
Torsten Herbert, Quality Engineer and Team Leader at sepp.med
Termin: July 8, 2026, 11:00 a.m.Duration: 20 minutes + Q&A
Secure your free spot now and get a clear picture of your AI-Act readiness while there’s still enough time to prepare thoroughly. Participation is free of charge; you will receive a recording and the presentation via email after the webinar. Register now!
Torsten Herbert studied physics at the Justus Liebig University in Giessen, specializing in applied physics - sensor technology.
After gaining more than eleven years of practical experience as a software developer in various industries, he joined sepp.med in 2006 in the field of software quality assurance and is now team leader.
He has multiple certifications, including CTFL, CTFL-AuT and CTAL TM, and has extensive experience as an IT consultant, project manager and test manager.
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