TEAM-NB DOCUMENTS Team-NB dpcuments

TEAM-NB DOCUMENTS

Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-20241218
18/12/2024
Team-NB-List-PositionPapers-20241218 18/12/2024
Joint-Team-NB-IG-NB-PositionPaper-AI-in-MD-Questionnaire-V1.1 10/12/2024
Team-NB-List-PositionPapers-20241210 10/12/2024
Team-NB-List-PositionPapers-20241125 25/11/2024
Team-NB-PositionPaper-IVD-Transfer-Agreement-20240911 11/09/2024
Team-NB-List-PositionPapers-20240911
11/09/2024
Team-NB-IVDConfirmationLetterTemplate-V2-20240710 10/07/2024
Team-NB-List-PositionPapers-20240710 10/07/2024
Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions 02/07/2024
Team-NB-List-PositionPapers-20240702 02/07/2024
Team-NB-List-PositionPapers-20240613 13/06/2024
Team-NB-List-PositionPapers-20240221 21/02/2024
Team-NB-PositionPaper-Classification-of-SARS-Cov2 02/02/2024
Team-NB-List-PositionPapers-20231218 18/12/2023
Team NB PositionPaper Lifetime Medical Device 27/11/2023
Team-NB List PositionPapers 20230821 21/08/2023
Team-NB PositionPaper LegacyMD Surveillance Transfer Agreement V1 11/08/2023
Team-NB PositionPaper MDR Transition Timelines Notified Body Capacity V1 10/08/2023
Team-NB PositionPaper NB-ConfirmationLetterEU2023-607 V2 10/07/2023
Team-NB-PositionPaper-HybridAudits-V2-20230516
16/05/2023
Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419 19/04/2023
Team-NB PositionPaper-BPG-IVDR-V1-20230225 25/02/2023
TEAM-NB Position in Response to MDCG 2022-14 Item Number 17 – ‘Certificates under Conditions’ 11/11/2022
Team-NB-PositionPaper-AI-Designation-V1-20221216 16/12/2022
Team-NB PositionPaper Voluntary Transfer Agreement V1 20221005
05/10/2022
TEAM-NB-Bullet-Points 09/05/2018
Team-NB-MDR-IVDR-Application-201712 14/12/2017
Team-NB-Statement-20171120 20/11/2017
Debriefing of General Assembly of Team-NB 11/10/2016
Team-NB-Position-paper-Workload-NBs-20151029 29/10/2015
TEAM-NB-Statement-6-October-Common-Position-of-the-Council-IVD 06/10/2015
Team-NB-Position-paper-new MDR 02/09/2015
Transfer-Agreement-Draft-1.0 02/03/2015
EU-eIFU-NBMed-Position-Statement-NBMed-April-17-2013 15/10/2013
TEAM-NB position paper on key areas of debate on MDD and IVDD 20/02/2014
TEAM-NB-PositionPaper-ENISO14971-2012 16/04/2013
TEAM-NB-Position-Paper-VisionOnRevisionMedicalDeviceRegulations 3/01/2013
TEAM NB Draft PositionPaper Authorized Representatives Audit 1 11/15/2012