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DTSTART;TZID=Europe/Brussels:20261117T140000
DTEND;TZID=Europe/Brussels:20261117T153000
DTSTAMP:20261008T123715Z
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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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DTSTART;TZID=Europe/Brussels:20261203T140000
DTEND;TZID=Europe/Brussels:20261203T153000
DTSTAMP:20261022T135739Z
CREATED:20260821T102058Z
LAST-MODIFIED:20261022T135739Z
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SUMMARY:Live Q&A Session on the New ISO 18969 with Danielle Giroud
DESCRIPTION:Your Questions on the New Clinical Evaluation Standard — Answered by the ISO Working Group Convenor \nDATE POSTPONE TO THE 3 DECEMBER 2026 \nDate: 3 December 2026 | Time: 14:00 CET\nFormat: Online Session (Zoom) \nThe publication of ISO 18969\, Clinical evaluation of medical devices\, marks an important development for professionals involved in the clinical evaluation of medical devices. As a new international standard\, ISO 18969 introduces principles and a structured process for planning and performing clinical evaluation throughout the medical device lifecycle. \nWith a new standard naturally come new questions: What does ISO 18969 mean in practice? How should its requirements and principles be interpreted? What should you consider when applying it to your clinical evaluation activities? \nThis live Q&A session is your opportunity to ask those questions directly to Danielle Giroud\, Convenor of the ISO Working Group responsible for ISO 18969. Drawing on her first-hand involvement in the development of the standard\, Danielle will address participants’ questions and provide insights into its principles\, intent and practical application. \nThe session will be dedicated to your questions. Participants are encouraged to ask questions live during the event or submit them in advance when registering (support@iceps-mdivd.org). Whether there is a particular section of the standard you would like to better understand\, a point you would like clarified\, or a practical challenge you are already considering\, this is the time to ask. \nTake advantage of this opportunity to discuss the newly published ISO 18969 with someone directly involved in its development and gain a clearer understanding of what the new standard means for clinical evaluation in practice. \nSpeakers\nDanielle Giroud\nFounder\, CEO\, 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. \n  \nPractical Information\n\nDate: 3 December 2026\nTime: 14:00–15:30 CET\nDuration: 1 hour 30 minutes\nFormat: Online via Zoom\nRegistration Fee: Free for ICEPS members and 20€ for non-members (VAT excl.)\nZoom Access: The Zoom 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\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 
URL:https://iceps-mdivd.org/event/live-qa-session-on-the-new-iso-18969-with-danielle-giroud/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/08/261029-QA-ISO-18969-2.png
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DTSTART;VALUE=DATE:20270310
DTEND;VALUE=DATE:20270312
DTSTAMP:20260930T092903Z
CREATED:20260611T103407Z
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SUMMARY:ICEPS 2027 Conference
DESCRIPTION:Creating Value Across the Medical Device Lifecycle\nJoin us on 10th and 11th of March 2027 for the ICEPS Medical Devices & IVD Conference\, a hybrid event bringing together experts\, industry leaders\, regulators\, HTA specialists\, HEOR professionals\, and innovators from across the medical device ecosystem. \nConference Theme\nCreating Value Across the Medical Device Lifecycle \nThis year’s theme highlights value creation at every stage of the medical device lifecycle\, from innovation and development to market access\, reimbursement\, patient access\, and real-world outcomes. The programme will integrate key perspectives including Health Technology Assessment (HTA) and Health Economics and Outcomes Research (HEOR). \nEvent Format\nThe conference will be held in a hybrid format\, allowing participants to attend either in person or online. \n\nIn-person participants will have access to all conference sessions\, workshops\, and roundtable discussions.\nOnline participants will have access to the main conference sessions but will not have access to workshops and roundtable discussions.\n\nThe Zoom access link for virtual attendees will be sent a few days before the event. \nVenue\nSilversquare Bailli\nAvenue Louise 251\n1050 Brussels\, Belgium \nRegistration\nRegistration opens now \nPlease note that the number of places is limited\, and registrations will be processed on a first-come\, first-served basis. \nRegistration Fees\n\nIn-person attendance: €500 (excluding VAT) for ICEPs members and €700 non-members\nOnline attendance: €400 (excluding VAT) for ICEPs members and €600 non-members\n\nProgramme\nThe detailed conference programme will be announced at a later date. \nFooter Simple \n \nSponsorship Opportunities\nOrganizations interested in sponsoring or collaborating with the conference are invited to contact us at: \nsupport@iceps-mdivd.org \nWe look forward to welcoming you to Brussels for two days of discussion\, learning\, and networking dedicated to creating value across the medical device lifecycle.
URL:https://iceps-mdivd.org/event/iceps-2026-conference/
LOCATION:Silversquare Bailli\, Avenue Louise 251\, Brussels\, 1050\, Belgium
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/06/ICEPS-2027-Conference-Wordpress-visual-1.png
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