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Full Schedule

Full Schedule

  • Friday, May 12, 2023
  • 08:00 – 16:30 CEST
    Cloak Room
  • 08:00 – 16:30 CEST
    Registration Open
  • 08:30 – 16:00 CEST
    Poster Viewing
  • 08:45 – 10:00 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 10:00 – 10:30 CEST
    Chapter/Local Networking Group Meet and Greets
  • 10:00 – 10:45 CEST
    Refreshment Break in Exhibit Area
  • 10:15 – 10:45 CEST
    Presenters at Posters
  • 10:45 – 11:45 CEST
    Device Lifetime and Lifecycle Management
  • 10:45 – 11:45 CEST
    EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions
  • 10:45 – 11:45 CEST
    Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
  • 10:45 – 11:45 CEST
    Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
  • 12:00 – 13:00 CEST
    Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
  • 12:00 – 13:00 CEST
    Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?
  • 12:00 – 13:00 CEST
    UKCA: challenges and opportunities
  • 12:00 – 13:00 CEST
    Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?
  • 12:45 – 13:45 CEST
    Chapter/Local Networking Group Meet and Greets
  • 13:00 – 14:00 CEST
    Lunch, Exhibits, Posters
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Digitized Regulatory Intelligence: Empowering Compliance & Professionals
  • 13:15 – 13:45 CEST
    Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Global regulatory platform vs integrations: Challenges for data consistency
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Streamlining Regulatory Affairs: Industry trends & Innovations
  • 13:15 – 13:45 CEST
    Sponsored Presentations: The Impact of AI on MedTech: Current and Future Applications
  • 14:00 – 15:00 CEST
    Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions
  • 14:00 – 15:00 CEST
    Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
  • 14:00 – 15:00 CEST
    Standards & Compliance: Updates on ‘Sustainable’ Medical Devices
  • 14:00 – 15:00 CEST
    Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
  • 15:00 – 15:30 CEST
    Chapter/Local Networking Group Meet and Greets
  • 15:00 – 15:30 CEST
    Presenters at Posters
  • 15:00 – 15:30 CEST
    Refreshment Break in Exhibit Area
  • 15:30 – 16:30 CEST
    Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication
  • 15:30 – 16:30 CEST
    Cybersecurity: Compliantly Securing our Healthcare Future
  • 15:30 – 16:30 CEST
    European Expedited Approval Pathways in a Global Context
  • 15:30 – 16:30 CEST
    MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
  • 16:30 – 17:00 CEST
    Closing Remarks & Farewell Toast