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DTSTART;TZID=Europe/Paris:20250507T083000
DTEND;TZID=Europe/Paris:20250507T123000
DTSTAMP:20260404T135938
CREATED:20250401T074846Z
LAST-MODIFIED:20260401T074615Z
UID:7517-1746606600-1746621000@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:
URL:https://www.team-nb.org/event/clinical-manufacturers-training/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250527T090000
DTEND;TZID=Europe/Paris:20250527T173000
DTSTAMP:20260404T135938
CREATED:20250523T102138Z
LAST-MODIFIED:20260401T074604Z
UID:7729-1748336400-1748367000@www.team-nb.org
SUMMARY:MDR Clinical Data Training
DESCRIPTION:
URL:https://www.team-nb.org/event/mdr-clinical-data-training/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250617T090000
DTEND;TZID=Europe/Paris:20250617T170000
DTSTAMP:20260404T135938
CREATED:20250523T102253Z
LAST-MODIFIED:20260401T074554Z
UID:7731-1750150800-1750179600@www.team-nb.org
SUMMARY:MDR TD Training for Manufacturers
DESCRIPTION:
URL:https://www.team-nb.org/event/mdr-td-training-for-manufacturers/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250618T090000
DTEND;TZID=Europe/Paris:20250618T170000
DTSTAMP:20260404T135938
CREATED:20250523T102506Z
LAST-MODIFIED:20260401T074549Z
UID:7739-1750237200-1750266000@www.team-nb.org
SUMMARY:MDR Software Training
DESCRIPTION:
URL:https://www.team-nb.org/event/mdr-software-training/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250703T090000
DTEND;TZID=Europe/Paris:20250703T170000
DTSTAMP:20260404T135938
CREATED:20250523T102327Z
LAST-MODIFIED:20260401T074536Z
UID:7733-1751533200-1751562000@www.team-nb.org
SUMMARY:IVDR TD Training for Manufacturers
DESCRIPTION:
URL:https://www.team-nb.org/event/ivdr-td-training-for-manufacturers/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250709T090000
DTEND;TZID=Europe/Paris:20250709T170000
DTSTAMP:20260404T135938
CREATED:20250523T102534Z
LAST-MODIFIED:20260401T074510Z
UID:7741-1752051600-1752080400@www.team-nb.org
SUMMARY:MDR PMS Training
DESCRIPTION:
URL:https://www.team-nb.org/event/mdr-pms-training/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20250827T133000
DTEND;TZID=Europe/Paris:20250827T173000
DTSTAMP:20260404T135938
CREATED:20250523T102406Z
LAST-MODIFIED:20260401T071037Z
UID:7735-1756301400-1756315800@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers/
CATEGORIES:Public
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20251107T090000
DTEND;TZID=Europe/Paris:20251107T173000
DTSTAMP:20260404T135938
CREATED:20250914T093402Z
LAST-MODIFIED:20260401T071001Z
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
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2025/09/event-list-day.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260226T133000
DTEND;TZID=Europe/Paris:20260226T173000
DTSTAMP:20260404T135938
CREATED:20260224T074808Z
LAST-MODIFIED:20260401T074226Z
UID:8253-1772112600-1772127000@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n275 € for SMEs – Priority for SMEs registration (25 places reserved) until December 31st\n550 € for organisation \nYou can register until : SOLD OUT \n\nEvent Summary\nClinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples.\n\nThis training is directed towards manufacturers/participants who already have experience in creating CER and/or are involved in CE submission. Therefore\, the training will focus more on real cases examples and less on introduction or citing regulations.  \nThe topics are presented by MDR experts of designated notified bodies.\n\nThe content was elaborated by MDR experts of 3 notified bodies\, namely BSI\, CeCertiso\, Dekra.\n\nThis training is intended for participants who are members of a manufacturer’s clinical team and have experience in creating CERs and/or are involved in CE submission. Therefore\, can you consider this exper-tise for registrations.  \n\nPROGRAM\n\n\n\n13.30 – 13.45\n\nWelcome and logistic information\n\n\n\n\n\n\n\n13.45 – 14.35\n\nClinical evaluation routes\n\n\n\n\nÁgnes Horvath\, CE Certiso\n\n\n\n\n\n\n\n14.35 – 15.25\n \nHow to build sufficient clinical evidence?\n\n\n\n\nNunung Nur Rahmah\, Dekra NL\n\n\n\n\n\n\n\n15.25 – 15.40\n\nBreak\n\n\n\n\n\n\n\n15.40 – 16.30\n \nPost market surveillance and PMCF\n\n\n\n\nBreda Kearney\, BSI\n\n\n\n\n\n\n\n16.30– 17.00\n \nQ&A session\n\n\n\n\n\n\n\n17.00 – 17.30\n \nClosing session\n\n\n\n\n\n\n\n\n\n 
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers-2/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/02/notified-368.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260429T090000
DTEND;TZID=Europe/Paris:20260429T170000
DTSTAMP:20260404T135938
CREATED:20260224T073154Z
LAST-MODIFIED:20260401T111817Z
UID:8247-1777453200-1777482000@www.team-nb.org
SUMMARY:MDR Technical Documentation Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n495 € for SMEs – Priority for SMEs registration (25 places reserved) until February 28th\n990 € for organisation \nYou can register until April 10th \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 MDR requirements related to Technical Documentation and share notified bodies insights; it is also planned to review the Team-NB Technical Documentation Best Practice document for MDR (version 3—published on April 9th\, 2025 \nThe topics are presented by MDR experts of designated notified bodies.\n\nThe content has been developed and is presented by MDR experts from members of 11 notified bodies\, namely BSI\, CeCert\, CeCertiso\, Dekra\, DNV\, ECM\, GMED\, NSAI\, SGS\, TÜV Rheinland\, TÜV SÜD. \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome and logistic information\n\n\n\n\n\n\n\n09.30 – 10.15\n\nStructure of Technical Documentation\n\n\n\n \nAlessandro Nicoletti\, Entercerma\n\n\n\n\nDavid Burke\, NSAI\n\n\n\n \nPurvi Patel\, BSI\n\n\n\n \nSebastian Sowiński\, Ce Cert\n\n\n\n \nVirginie Siloret\, SGS Belgium\n\n\n\n \n\n\n\n\n\n\n\n\n10.15 – 10.30\n \nBreak\n\n\n\n\n\n\n\n10.30 – 12.00\n\nMDR Annex II Sections 1-3\n\n\n\n \nAlexandra Seber\, TÜV SÜD\n\n\n\n \nAnnapoorna Rajan\, Dekra NL\n\n\n\n \nVirginie Siloret\, SGS Belgium\n\n\n\n \nYannick Peron\, BSI\n\n\n\n\n\n\n\n12:00 – 13:15\n \nLunch\n\n\n\n\n\n\n\n13.15 – 14.45\n \nMDR Annex II Sections 4-6 (excluding clinical data)\n\n\n\n\nAmy Chan\, GMED\n\n\n\n\nAndreas Klotz\, TÜV SÜD\n\n\n\n\nChristoph Ziskoven\, TÜV Rheinland\n\n\n\n\nLisa Moloney\, BSI\n\n\n\n\nRegine Großkopf-Lüdemann\, TÜV Rheinland\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.30\n \nMDR Annex II Section 6 (clinical data) and An-nex III (post-market surveillance)\n\n\n\n \nÁgnes Horvath\, CE Certiso\n\n\n\n \nAlexey Shiryaev\, DNV\n\n\n\n \nAnna Pietersma\, Dekra NL\n\n\n\n \nBreda Kearney\, BSI\n\n\n\n \nMaria Karakitsou\, SGS Belgium\n\n\n\n \nNunung Nur Rahmah\, Dekra NL\n\n\n\n\n\n\n\n16.30 – 17.00\n \nClosing session
URL:https://www.team-nb.org/event/mdr-technical-documentation-training-for-manufacturers/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/02/MDR-TECHNICAL-TRAINING.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260528T090000
DTEND;TZID=Europe/Paris:20260528T163000
DTSTAMP:20260404T135938
CREATED:20260308T165211Z
LAST-MODIFIED:20260401T110610Z
UID:8289-1779958800-1779985800@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n600 € for SMEs – Priority for SMEs registration (25 places reserved) until March 27th\n1200 € for organisation \nYou can register until April 28th \n\nEvent Summary\nClinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples.\n\nThis training is directed towards manufacturers/participants who already have experience in creating CER and/or are involved in CE submission. Therefore\, the training will focus more on real cases examples and less on introduction or citing regulations.  \nThe topics are presented by MDR experts of designated notified bodies.\n\nThe content was elaborated by MDR experts of 3 notified bodies\, namely BSI\, CeCertiso\, Dekra.\n\nThis training is intended for participants who are members of a manufacturer’s clinical team and have experience in creating CERs and/or are involved in CE submission. Therefore\, can you consider this exper-tise for registrations.  \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome and logistic information\n\n\n\n\n\n\n\n09.30 – 10.45\n\nClinical evaluation routes\n\n\n\n \nÁgnes Horvath\, CE Certiso\n\n\n\n\n\n\n\n10.45 – 11.00\n \nBreak\n\n\n\n\n\n\n\n11.00 – 12.30\n\nHow to build sufficient clinical evidence?\n\n\n\n \nNunung Nur Rahmah\, Dekra NL\n\n\n\n\n\n\n\n12:30 – 13:30\n \nLunch\n\n\n\n\n\n\n\n13.30 – 14.45\n \nPost market surveillance and PMCF\n\n\n\n\nBreda Kearney\, BSI\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.00\n \nQ&A session\n\n\n\n\n\n\n\n16.00 – 16.30\n \nClosing session\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nREGISTRATION
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers-3/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/04/MDR-CLINICAL-TRAINING.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260702T090000
DTEND;TZID=Europe/Paris:20260702T170000
DTSTAMP:20260404T135938
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
END:VEVENT
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