Anyone in the medical technology industry who develops software as a medical device (SaMD) with AI components knows the feeling. You have implemented the ISO 13485 quality management system (QMS), ensured compliance with the Medical Device Regulation (MDR), and then the EU AI Act appears on the horizon. Well, you think, the QMS is up and running. But is that enough?
The honest answer is almost always: only partially. From August 2026 onwards, the high-risk requirements of the AI Act (Articles 9 to 17) will apply to almost all AI-based SaMD in Classes IIa to III. While an existing MDR-compliant QMS provides a solid foundation for this, it does not guarantee compliance.
The following list highlights patterns that regularly emerge in practice. This is not intended as criticism, but rather as a guide. Which of these apply to you?
One might argue that these are merely documentation gaps that can be resolved quickly. This is true for some aspects, but not all.
For example, missing data governance cannot be retrofitted overnight once the data has already been collected. Changing the Notified Body is not a mere bureaucratic formality but rather a process that can significantly prolong an ongoing recertification cycle. Risk management SOPs that do not provide a methodology for AI-specific risks must be written and implemented. That takes time.
We know this from real-world experience. Gaps that seem manageable during an internal review become real problems during an audited under time pressure. Each week that your readiness status remains unclear reduces your ability to adapt as the deadline approaches.
If you recognize one or more of the warning signs mentioned above, our upcoming webinar will provide the guidance you need.
In 20 minutes, Torsten Herbert will present specific checkpoints that you can use to assess your QMS's AI Act readiness. You will receive assessment questions to incorporate into your next internal review, quick wins to implement immediately with minimal effort, and the opportunity to ask your own questions during a moderated Q&A session.
A checklist is no substitute for a comprehensive gap assessment. However, it shows you where you stand. That’s the essential first step.
Reserve your spot in the webinar “EU AI Act effective August 2026: The 5 most common gaps in MedTech QMSs … and how to close them” and find out where your QMS truly stands.
A basic understanding of the MDR or IVDR requirements is sufficient. The AI Act and its requirements will be concisely explained in the webinar, so you can follow along without any prior knowledge.
Yes. All registered participants will receive the recording via email after the webinar in case you are unable to attend live.
Yes, you can ask your own questions during the moderated Q&A session following the presentation. All questions asked will also be answered in writing afterward.
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