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
NBs representatives invited to present their views on future developpement of the Regulations. L’article Notified Bodies delegation meeting Commission representantives est apparu en premier sur team-nb.| team-nb
NBCG-Med and Team-NB committees propose a future governance model based on works and exchanges among NBs. NB-Perspective-on-Future-Governance-in-EU-medical-device-sector-20250728 L’article Notified Body Perspective on Future Governance in the EU Medical Device Sector est apparu en premier sur team-nb.| team-nb
The position paper includes a proposal for a definition of an orphan IVD and for an approach to conformity assessment for this type of devices. The paper was developed taking into account existing guidelines for medical devices i.e. MDCG 2024-10. Team-NB-PositionPaper-Ophan-IVDR-Medical-Devices-V1-20250717 L’article TEAM NB Position Paper on Orphan under the IVDR V1 est apparu en premier sur team-nb.| team-nb
TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on September 17th, 2025. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining L’article Tenth session : MDR Technical Documentation Training for Manufacturers est apparu en premier sur team-nb.| team-nb
The “IVD Software Working” Task Force members who represented 15 members drafted an updated 2nd version of a position paper addressing Software qualification under the IVDR. The decision tree was simplified and also some terminology was improved, including the examples as mentioned in the text below the scheme. Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627 [...] L’article TEAM NB Position Paper on Software qualification under the IVDR V2 est apparu en premier s...| team-nb
Team-NB representatives met with a MEP responsible for the SANT committee to present the work carried out by the NB with one of the objectives of guaranteeing patient safety. L’article Team-NB at European Parliament est apparu en premier sur team-nb.| team-nb
A minor revision has been made to align with the wording of a guidance published after adoption. Code-of-Conduct-Team-NB-V5-1-20250625 L’article Code of Conduct 5.1 est apparu en premier sur team-nb.| team-nb
The press release and the graphs with all data from the 41 designated members at end 2024 are available now. They are both available in the Team-NB Documents L’article Team-NB 2024 annual sector survey 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