Adopting a Lifecycle Approach to Enhance Access to Innovative Medical Devices: Regulatory Insights and Future Perspectives As the leading Notified Body in EU, it has been interesting to listen to this dialogue between Competent Authorities and leading players in the European MedTech sector. While the MDR aims to ensure patient safety while enabling access to safe and innovative medical devices, its stringent requirements may present key challenges for manufacturers, especially when it comes to navigating the complex regulatory landscape. These challenges may include ensuring compliance with rigorous clinical evidence requirements, meeting the increased scrutiny of high-risk devices, and managing the timelines necessary for obtaining market access. At the same time, there is a clear opportunity to explore innovative pathways that can accelerate access to breakthrough technologies. Streamlining regulatory processes, embracing adaptive pathways, and fostering collaboration among stakeholders can play a pivotal role in facilitating quicker patient access to novel and potentially life-changing devices. This event highlighted the importance of understanding the full lifecycle of a medical device and the regulatory hurdles that must be addressed at each stage. Innovative approaches, such as early dialogue with Notified Bodies and leveraging scientific advice, can provide manufacturers with valuable insights that support more efficient regulatory pathways. We would like to express our gratitude to all the speakers and participants for their contributions and feedback. These insights are crucial as we continue to refine regulatory processes to ensure they strike the right balance between patient safety and access to innovation. We are always keen to support the dialogue between EU policy makers and manufacturers to ensure patient safety whilst supporting timely market access to medical technology. Thank you to Ester Leoni, Global Regulatory Comms Manager and to Ferdinando Lamagna Marketing Manager for representing BSI Medical Devices at such a significant and impactful event. Our thanks also to SDA Bocconi for organizing and hosting this event, providing a platform for such valuable exchanges. #BSI #MedicalDevices #InnovationPathways #SDABocconi
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