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SUMMARY:Clinical Evidence for Breakthrough designation in Europe
DESCRIPTION:Webinar | 17 November 2026 | 2:00 PM CET \nAbout the Webinar\nThe pathway for breakthrough medical devices in Europe creates new opportunities for innovative technologies addressing unmet clinical needs — but it also raises an important question: how much clinical evidence is enough? \nThis webinar will explore the clinical evidence expectations for breakthrough devices in the context of MDCG 2025-9\, with a particular focus on demonstrating safety and clinical performance while managing residual uncertainties through continuous post-market clinical evidence generation. ICEPS_BtX \nParticipants will gain practical insights into how to determine and justify an appropriate level of clinical evidence when preparing for the CE-marking process. \nWhat Will Be Discussed?\nThe session will address key considerations including: \n\nDefining sufficient clinical evidence for breakthrough devices\nPre-market versus post-market evidence requirements\nClinical investigation design and appropriate endpoints\nContinuous clinical evidence generation through PMCF\nThe role of expert panels and early clinical dialogue ICEPS_BtX\n\nThe webinar will combine expert perspectives with a dedicated Q&A session\, giving participants the opportunity to discuss practical questions and challenges. \nSPEAKER\nDanielle Giroud \nFounder\, Chief Executive Officer MD-CLINICALS & WMDO \nWith close to 40 years of experience\, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies\, organizations\, and start-ups from around the world to help bring their products to market quickly and efficiently. \nMs. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). \nSince 2008 she is the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and clinical evaluation for the ISO 18969\, and functions as a liaison with the EU Commission – Clinical Investigation and Evaluation\, Performance Studies and Evaluation (CIEPSE) task force and other regulatory authorities throughout the world. \nDr Langhit Kurar\nGlobal Orthopaedic SME (Subject Matter Expert) \nDr Langhit Kurar is a UK-trained orthopaedic surgeon and Clinical Reviewer at TÜV SÜD\, specialising in the clinical evaluation of medical devices under the EU MDR. He leads the clinical component of TÜV SÜD’s internal Breakthrough Device (BtX) programme and has particular expertise in high-risk and implantable medical devices. He is also lead author of TÜV SÜD’s recent white paper on the EU Breakthrough Device pathway. \nWho Should Attend?\nThis webinar is particularly relevant for clinical and regulatory affairs professionals working with innovative medical devices and IVD technologies\, whether in start-ups\, SMEs or larger organisations. ICEPS_BtX \nWhat Will You Take Away?\nBy the end of the session\, participants will have a clearer understanding of how to approach and justify sufficient clinical evidence for breakthrough devices\, as well as how continuous evidence generation can support the device during the post-market phase. ICEPS_BtX \nPractical Information\n\nDate: 17 November 2026\nTime: 2:00 PM CET\nFormat: Online via Zoom\nRegistration Fee: Free for ICEPS members and 20€ for non-members (VAT excl.)\nZoom Access: The Zoom registration link and connection details will be sent by email.\nRecording: The session will be recorded\, and access to it will be only for ICEPS members.\n\nHave questions about clinical evidence for breakthrough devices?\nImportant Information\nPlease note that this event is a webinar only. \nParticipants will have the opportunity to ask questions and exchange directly with the expert speaker. \nThis session is not a training course\, and participation does not provide a certificate of attendance\, training completion\, or certification. \nYour Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice. \nThe session is recorded and only available for ICEPS members. \n  \nJoin our experts on 17 November and gain practical insights into navigating clinical evidence requirements for breakthrough designation in Europe. \n 
URL:https://iceps-mdivd.org/event/clinical-evidence-for-breakthrough-designation-in-europe/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/10/VISUAL1.png
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