In this episode of MedTech Global Insights, we demystify the International Medical Device Regulators Forum (IMDRF) framework for Software as a Medical Device (SaMD). We break down the two-dimensional matrix used to classify SaMD risk, exploring how the significance of the information and the patient's condition determine whether your software is Class I or Class IV. We move beyond theory with concrete examples, from a simple skin-care app to a high-stakes AI diagnostic tool for cancer treatment. This discussion highlights how risk classification directly impacts your regulatory burden, development costs, and speed to market, explaining why a harmonized framework still results in a fragmented global landscape that innovators must navigate carefully. A Real-World Challenge: Imagine you've developed an AI-powered diagnostic tool that analyzes medical images to detect early-stage neurological disorders. You believe it’s revolutionary, but you're facing a critical roadblock. Is it a Class II or a Class III device under the EU MDR? Classifying it incorrectly could mean your entire technical dossier is rejected, leading to millions in wasted development costs and years of delay in getting your life-saving technology to patients. What You'll Learn in This Episode: - What are the two critical questions the IMDRF asks to determine SaMD risk? - How can a simple app that tracks data be considered a medical device? - Why does an AI diagnostic tool face tougher regulations than a diabetes management app? - What is the difference between "informing" versus "driving" clinical management? - How does your SaMD's risk classification directly impact your budget and time-to-market? - Why isn't the IMDRF framework a "one-size-fits-all" solution for global market access? - How does the classification change the level of clinical evidence you need to provide? Contact us at [email protected] or visit https://pureglobal.com/ for more information.