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CREATED:20250914T093402Z
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UID:7866-1762506000-1762536600@www.team-nb.org
SUMMARY:Team-NB 1st EU Regulations Discussion Day 2025
DESCRIPTION:Registration Fees & Deadlines\n250 € for SMEs and Notified Bodies members\n400 € for organisations \nYou can register until October 28th \n\nEvent Summary\nThis event aims to foster exchanges between stakeholders in the medical device sector.\nThree topics of topical matters have been chosen for their relevance to the implementation of the regulatory system.\nTeam-NB task forces on those matters will present Papers and ongoing work. Members present will answer questions and take note of developments requested by manufacturers.\nAn information session on EUDAMED will be presented by Commission experts. It will also be followed by discussions.\nFinally\, Team-NB’s views on the revision outlook will be presented\, and a panel of regulators\, industry representatives\, and notified bodies will answer participants’ questions.\nThis day will provide an excellent forum for exchanges between regulators\, industry representatives\, and notified bodies on opportunities for optimizing and modifying the system. \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome coffee\n\n\n\n\n\n\n\n09.30 – 09.45\n\nWelcome and Introduction\n\n\n\n \nFrançoise Schlemmer – Team-NB Director\n\n\n\n\n\n\n\n09.45 – 10.30\n \nBPG on Technical Documentation MDR / IVDR\n\n\n\n \nJayanth Katta\, BSI\n\n\n\n \nAlessandro Nicoletti\, Entercerma\n\n\n\n \nChristoph Ziskoven\, TÜV Rheinland\n\n\n\n\n\n\n\n10.30 – 11.15\n \nCAP (Conformity Assessment Process) Harmonistation \n\n\n\n \nMarta Carnielli\, TÜV SÜD\n\n\n\n \nVirginie Siloret\, SGS Belgium\n\n\n\n \nBéatrice Lys\, GMED\n\n\n\n\n\n\n\n11.15 – 12.15\n\nEUDAMED information – state of play by Commission\n\n\n\n \nPierre-Francois Ryelandt\, European Commission\n\n\n\n \nSilvia Ostuni\, European Commission\n\n\n\n\n\n\n\n12:15 – 13:45\n \nLunch\n\n\n\n\n\n\n\n13.45 – 14.00\n \nWelcome \n\n\n\n\n\n\n\n14.00 – 14.15\n \nIntroduction on the status of the regulatory revisions\n\n\n\n \nFlora Giorgio\, European Commission\, Head of Unit DG SANTE D3 Medical Devices \n\n\n\n\n\n\n\n14.15 – 14.30\n \nNBs perspective on the revision\n\n\n\n \nAlexey Shiryaev\, – Team-NB President – DNV\n\n\n\n\n\n\n\n14.30 – 15.15\n \nPanel\n\n\n\n \nOliver Bisazza\, Medtech Europe\n\n\n\n \nOliver Böhle\, EUROM\n\n\n\n \nÁgnes Horváth\, CECERTISO\n\n\n\n \nSabina Hoekstra\, Team-NB Vice-President- TÜV SÜD\n\n\n\n\n\n\n\n15.15 – 15.30\n\nBreak\n\n\n\n\n\n\n\n15.30 – 16.15\n\nArtificial Intelligence\n\n\n\n\nSebastian Fischer\, TÜV SÜD\n\n\n\n\nGeorge Dafoulas\, EKAPTY\n\n\n\n\nAnni Koubek\, QMD Services\n\n\n\n\n\n\n\n16.15 – 16.30\n\nExchanges and closing\n\n\n\n\n\n\n\n16.30\n\nDrinks\n\n\n\n\n 
URL:https://www.team-nb.org/event/team-nb-1st-eu-regulations-discussion-day-2025/
LOCATION:Sofitel Brussels Europe\, Place Jourdan\, 1\, Brussels\, 1040\, Belgium
CATEGORIES:Public
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