Team-NB members adopted during the General Assembly meeting, at the unanimity of the IVD NBs presents, a guidance on the interpretation used by notified bodies to identify changes affecting the performance, suitability, or intended use of a companion diagnostic device that necessitate consultation with medicinal product authorities. Team-NB-PositionPaper-IVDR-Significant-changes-V2 L’article TEAM NB Position Paper on IVDR Changes to companion diagnostic devices est apparu en premier sur tea...| team-nb
Team-NB invited to present NBs views on revision of Regulations. L’article Team-PRRC Rome est apparu en premier sur team-nb.| team-nb
Discover the final programme and join the already registered representatives from Competent Authorities, industry associations, manufacturers, consultants and NBs. More info on https://www.team-nb.org/event/team-nb-1st-eu-regulations-discussion-day-2025/ L’article Team-NB 1st EU Regulations Discussion Day 2025 – November 7th est apparu en premier sur team-nb.| team-nb
Team NB responded to DG Connect's consultation to clarify their role in ensuring the high level of protection of health, safety, and fundamental rights envisaged by the AI Act. The NBs support the overall objective of creating legal clarity and predictability, particularly with regard to the optimal application of the AI Regulation. More info:| team-nb
Team-NB members and notified bodies non members have worked together since early summer 2025 to develop the attached proposal, outlining views on some of the most crucial topics in the framework of the ongoing MDR and IVDR review process. NBs-MDRIVDR-Call-For-Evidence-TargetedRevision-EUrules-20250106 L’article NBs views on MDR and IVDR review process est apparu en premier sur team-nb.| team-nb
All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 21st to 23rd. These meetings will take place remotely.| team-nb
The association meeting is scheduled on October 22nd. L’article Team-NB – General Assembly meeting est apparu en premier sur team-nb.| team-nb
Manufacturers, Regulators, Notified Bodies are invited to this forum for discussions and opportunities to optimize the system. For registration, follow the link: https://www.team-nb.org/team-nb-eu-regulations-discussion-day-2025/ More information in the agenda below.| team-nb
Team-NB members adopted a position paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation. Team-NB-PositionPaper-BPG-IVDR-V2-20250903| team-nb
The August 27th session being fully booked, TEAM-NB set up a new ½ day training for manufacturers dedicated to clinical aspects. It is planned on November 20th morning. More info available in the leaflet thanks to a click: Leaflet-MDR-Clinical-Manufacturers-Training-20251120 For registration, follow the link: ManufacturerTraining L’article New session : MDR Clinical Training for Manufacturers est apparu en premier sur team-nb.| team-nb
TEAM-NB DOCUMENTS Code-of-Conduct-Team-NB-V5-1-20250625 25/06/2026| team-nb
