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BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20261106T090000
DTEND;TZID=Europe/Paris:20261106T170000
DTSTAMP:20260916T173901
CREATED:20260401T120420Z
LAST-MODIFIED:20260903T092502Z
UID:8370-1793955600-1793984400@www.team-nb.org
SUMMARY:2nd Team-NB EU Regulations Discussion Day 2026
DESCRIPTION:Registration Fees & Deadlines\n 300 € for SMEs and Notified Bodies members\n500 € for organisations \nYou can register until October 28th \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\nAlessandro Nicoletti\, Entercerma\n\n\n\n\nChristine Quinton\, Afnor\n\n\n\n\nDavid Burke\, NSAI\n\n\n\n\n\n\n\n10.15 – 10.45\n \nDIGItalisation of the Conformity Assessment Process\n\n\n\n\nPeter Kramar\, SIQ\n\n\n\n\nMarta Carnielli\, TÜV SÜD\n\n\n\n\nValérie Dumay\, GMED\n\n\n\n\n\n\n\n10.45 – 11.00\n\nBreak\n\n\n\n\n\n\n\n\n\n\n\n\n11.00 – 11.30\n\nEUDAMED – feedback on 1st mandatory use\n\n\n\n\nNatascha Jezyschek\, Dekra NL\n\n\n\n\nKatja Mierisch\, TÜV Rheinland\n\n\n\n\nSudhanshi Jain\, QMD Services\n\n\n\n\n\n\n\n11.30 – 12.00\n\nBreakthrough Devices Pilot\n\n\n\n\n Nada Alkhayat\, European Commission\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\nFlora Giorgio\, European Commission\, Head of Unit DG SANTE D3 Medical Devices \n\n\n\n\n \n\n\n14.15 – 14.45\n \nNBs perspective on the revision\n\n\n\n\nAlexey Shiryaev – Team-NB President – DNV\n\n\n\n\n\n\n\n14.45 – 15.30\n \nPanel (EC + NBs)\n\n\n\n\nAnja Richter\, EUROM\n\n\n\n\nOliver Bisazza\, MedTech Europe\n\n\n\n\nSuzanne Halliday\, BSI\n\n\n\n\nJames Dewar\, Scarlet\n\n\n\n\n\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\nVolker Sudmann\, MDC\n\n\n\n\nDhananjay  Khairnar\, Dekra NL\n\n\n\n\nMarisa Torrini\, SGS Belgium \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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20261216T090000
DTEND;TZID=Europe/Paris:20261216T163000
DTSTAMP:20260916T173901
CREATED:20260915T103726Z
LAST-MODIFIED:20260915T104735Z
UID:8671-1797411600-1797438600@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\nFor SMEs – Priority for SMEs registration (25 places reserved) until September 25th\n1 person : 450€\n2 persons : 750€ \nFor organisation\n1 person : 900€\n2 persons : 1500€ \nYou can register until November 30th \nREGISTRATION\n\nEvent Summary\nClinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples. \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. \nThe content was elaborated by MDR experts of 3 notified bodies\, namely BSI\, CeCertiso\, Dekra. \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 \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n12:30 – 13:30\n \nBreak\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\nCancellation policy for training attendance \n\nCancellations must be notified in writing to Team-NB as soon as possible and\, in any case\, no later than 24 hours before the start of the training.\nFor cancellations received less than 24 hours before the start of the training\, no refund will be granted.\nA registered participant may be replaced by another person from the same organisation\, provided that Team-NB is informed before the start of the training and receives the replacement participant’s details.\nNo-shows will be treated as late cancellations and will not be eligible for refund.\nIf Team-NB cancels or postpones a training\, registered participants will be offered either a full refund or transfer to a new date\, where available.
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers-4/
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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