Post by TÜV AI.Lab

📜🧩 𝗧𝗘𝗙-𝗛𝗲𝗮𝗹𝘁𝗵 𝗗𝗲𝗲𝗽 𝗗𝗶𝘃𝗲 𝗡𝗼.𝟮: 𝗠𝗼𝘃𝗶𝗻𝗴 𝗧𝗼𝘄𝗮𝗿𝗱𝘀 𝗠𝗼𝗿𝗲 𝗔𝗴𝗶𝗹𝗲 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲 – 𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 𝗠𝗲𝗱𝗶𝗺𝗶𝗿 How does agile certification work in practice? Within the TEF-Health Work Package Certification, managed by the TÜV AI.Lab, the developed Agile Certification Process (ACP) prototype was piloted through a concrete use case with Medimir Systems GmbH. The use case focused on a significant planned change: The HealthTech Medimir had planned to build an AI content factory to automate the production of their Clinical Decision Support tools. The collaborative pilot of the ACP supported building the pipeline “compliant by design”, focusing on the MDR and the upcoming AI Act (according to current status). The focus was on making the intended change manageable from a regulatory perspective: 📊 A structured gap analysis identified where the existing MDR-compliant QMS needed adaptation to meet AI Act requirements. 🤝 Early and structured dialogue with the notified body is enabled through a Pre-Notification Template developed within the Agile Certification Process. 🔍 The template supports transparent communication of the intended change, its rationale, and its impact on safety, performance and benefit–risk balance. The results: ✅ Earlier regulatory engagement reduced uncertainty and avoided late-stage rework. 🔄 Medimir was able to continue developing AI functionality while staying aligned with MDR and AI Act expectations. 🇪🇺 The approach strengthened confidence to pursue development within the EU market. 🎯 This use case shows that key levers of agile certification can already be implemented within the existing regulatory framework when supported by structured processes and practical tools. Thank you to Dr. Philipp Boerm and Fidelio Noah Börm for providing this use case! ➡️ Stay tuned for our TEF-Health Deep Dive No.3: How regulatory uncertainty is driving the need for more agile regulatory approaches in medical AI. #TÜVAILab #TrustworthyAI #TEFHealth #AgileCertification #HealthAI #MedicalDevices #MDR #AIAct