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DTSTART;TZID=Europe/Paris:20260702T090000
DTEND;TZID=Europe/Paris:20260702T170000
DTSTAMP:20260422T234738
CREATED:20260401T113611Z
LAST-MODIFIED:20260401T114116Z
UID:8366-1782982800-1783011600@www.team-nb.org
SUMMARY:IVDR Technical Documentation Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n600 € for SMEs – Priority for SMEs registration (25 places reserved) until April 24th\n1200 € for organisation \nYou can register until June 1st \nREGISTRATION\n\nEvent Summary\nThe MDCG Position Paper Transition to the MDR and IVDR (MDCG 2022-14) encourages notified bodies to strengthen the communication with manufacturers by means of webinars\, workshops\, targeted feedback and informative sessions\n\nThe aim of this training is to review the IVDR requirements related to Technical Documentation and share notified bodies insights; \n; it is also planned to review the Team NB Technical Documentation Best Practice document for IVDR (published on March 1st 2023).\n\nThe topics are presented by IVD experts of IVDR designated notified bodies. The content was elaborated by IVD experts of 7 notified bodies\, namely BSI\, Dekra B.V.\, Dekra GmbH\, GMED\, NSAI\, TÜV Rheinland LGA and TÜV SÜD. \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome of participants\n\n\n\n\n\n\n\n09.30 – 10.45\n\nThe (pre) application phase\n\n\n\n \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n10.45 – 11.00\n \nBreak\n\n\n\n\n\n\n\n11.00 – 12.15\n\nDirective to Regulation data\n\n\n\n \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n12:15 – 13:30\n \nLunch\n\n\n\n\n\n\n\n13.30 – 14.45\n \nPerformance Evaluation\n\n\n\n\nQ&A moderated IVD expert\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.15\n \nPost market surveillance and PMCF\n\n\n\n\nQ&A moderated IVD expert\n\n\n\n\n\n\n\n16.15 – 17.00\n \nClosing session\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n 
URL:https://www.team-nb.org/event/ivdr-technical-documentation-training-for-manufacturers/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/04/IVDR-TD.jpg
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DTSTART;TZID=Europe/Paris:20261106T090000
DTEND;TZID=Europe/Paris:20261106T170000
DTSTAMP:20260422T234738
CREATED:20260401T120420Z
LAST-MODIFIED:20260419T195658Z
UID:8370-1793955600-1793984400@www.team-nb.org
SUMMARY:2nd Team-NB EU Regulations Discussion Day 2026
DESCRIPTION:Registration Fees & Deadlines\nEarly bocking\n250 € 300 € for SMEs and Notified Bodies members\n400 € 500 € for organisations \nYou can register until August 6th \nREGISTRATION\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 – 10.15\n \nBPG on Technical Documentation MDR / IVDR – version 2026\n\n\n\n\n\n\n\n10.15 – 10.45\n \nDIGItalisation of the Conformity Assessment Process\n\n\n\n\n\n\n\n10.45 – 11.00\n\nBreak\n\n\n\n\n\n\n\n11.00 – 11.30\n\nEUDAMED – feedback on 1st mandatory use\n\n\n\n\n\n\n\n11.30 – 12.00\n\nBreakthrough Devices Pilot\n\n\n\n\n\n\n\n12:00 – 13:30\n \nLunch\n\n\n\n\n\n\n\n13.30 – 13.45\n \nWelcome \n\n\n\n\n\n\n\n13.45 – 14.15\n \nRegulatory revisions – state of play \n\n\n\n\n\n\n\n14.15 – 14.45\n \nNBs perspective on the revision\n\n\n\n\n\n\n\n14.45 – 15.30\n \nPanel\n\n\n\n\n\n\n\n15.30 – 15.45\n\nBreak\n\n\n\n\n\n\n\n15.45 – 16.15\n\nArtificial Intelligence Act & MDR\n\n\n\n\n\n\n\n16.15 – 16.45\n\nExchanges and closing\n\n\n\n\n\n\n\n16.45\n\nDrinks\n\n\n\n\n 
URL:https://www.team-nb.org/event/2nd-team-nb-eu-regulations-discussion-day-2026/
LOCATION:Sofitel Brussels Europe\, Place Jourdan\, 1\, Brussels\, 1040\, Belgium
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/04/VIGNETTE-2nd-REGULATION.jpg
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