Combination devices are becoming unavoidable in MedTech. But under EU MDR, they're also one of the most misunderstood regulatory topics. This 3-episode series covers everything from definitions and clinical evidence hurdles to real-world evidence strategies.
Whether you're planning a new submission, managing a legacy device transition, or exploring how RWE fits into your MDR strategy, this podcast gives you the clarity you need to move forward with confidence.
Combination devices are going to be the future.
You need to find this data somehow.
Surveys need to be clear and well-designed.
Combination devices are becoming unavoidable in MedTech, but under EU MDR, they're also becoming one of the most misunderstood regulatory topics. Chems Hachani sits down with Dr. Fatima Sanfourche to clarify what a "combination device" actually is, the main categories regulators look at, and why MDR expectations are rising fast. If your product sits at the intersection of device + drug, this is where your regulatory strategy needs to start.
Combination products often require evidence that spans two worlds, device and drug, but the regulatory processes don't always move together. That gap is where timelines slip and costs explode. Chems Hachani and Dr. Fatima Sanfourche break down the real hurdles behind combined studies, what makes clinical planning so complex, and what legacy devices must do to transition to MDR compliance. If you're relying on "historical use" without a clear data plan, this episode will feel uncomfortably familiar.
Real-world evidence can strengthen an MDR strategy, but only when it's structured in a way regulators can trust. And surveys can support your clinical story, but they cannot replace clinical evidence from trials. Chems Hachani and Dr. Fatima Sanfourche explain when RWE is credible, why retrospective data quality is a recurring issue, and what "clear, well-designed surveys" actually means in practice. If you're planning to use RWE or user feedback to support compliance, this short episode can save you a lot of rework.
CEO & Founder, Eclevar MedTech
Over 10 years of experience in medtech, pharma, and CRO. Expert in autonomous clinical trials and regulatory strategy under EU MDR. Leading Eclevar MedTech's mission to transform how medical device clinical investigations are designed and executed.
Scientific Board Member, Eclevar MedTech
Regulatory affairs and clinical development expert with deep expertise in combination devices, EU MDR compliance, and pharmaceutical-device interface. Bringing critical insights on how manufacturers can navigate the evolving regulatory landscape.
