Team-NB documents

TEAM-NB DOCUMENTS

Team-NB of Conduct

Code-of-Conduct-Team-NB-V5-0-20240916	16/09/2024

Team-NB Positions Papers

Team-NB-PositionPaper-IVDR-Certification-Process-Consensus-Document-V1-20250409	09/04/2025
Team-NB-PositionPaper-EU-AI-Act-V2-20250409	09/04/2025
Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V3-20250409	09/04/2025
Team-NB-List-PositionPapers-20250409	09/04/2025
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-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

Documents 2025

TEAM-NB-Member-List-51	01/01/2025

Documents 2024

Team-NB-byFewFacts-and-Numbers-Strategy-20241213	13/12/2024
Survey-2023-20240513	15/05/2024
Team-NB-MD-Sector-Survey-PressRelease-20240515	15/05/2024

Documents 2023

Team-NB Member List 45	01/08/2023
TEAM-NB-22Anniversary-PressRelease-20230420	20/04/2023
Survey-2022-20230411	12/04/2023
Team-NB-MD-Sector-Survey-PressRelease-20230411	12/04/2023
Team-NB-Leaflet.pdf	25/01/2023

Documents 2022

Team-NB Position Paper Certificates under conditions-V1	20/12/2022
Team-NB PositionPaper-AI Designation-V1-20221216	16/12/2022
Team-NB Position Paper Modifications Sampling Plan V1	08/12/2022
Team-NB Position Paper IVDR Significant changes V1	08/12/2022
Team-NB Position Paper Article117 NB-Opinion Template V1	08/12/2022
TEAM-NB-Member-List-37-web	10/10/2022
Team-NB Position Paper Off Label Use V1	05/10/2022
Team-NB Position Paper Interimmeasures Verifclass D V1	05/10/2022
Team-NB Position Paper Cyber Security V1	05/10/2022
Team-NB MD Sector Survey PressRelease	16/05/2022
Survey 2021	16/05/2022
TEAM-NB Member List	01/03/2022

Documents 2021

TEAM-NB Member List	23/12/2021
Team-NB Position Paper on MDR IVDR Implementation V3	15/12/2021
Team-NB Position Paper Artificial Intelligence	07/10/2021
Team-NB PositionPaper Article117 NB Opinion Template V1	07/10/2021
Leaflet IVDR Performance 3	29/09/2021
Leaflet PMS Training 2	29/09/2021
Leaflet RemoteAudit Training 3	29/09/2021
Leaflet RiskManagement Training 3	29/09/2021
Leaflet Software Training 2	29/09/2021
Leaflet Technical Documentation Training 2022 2	29/09/2021
Leaflet Clinical Data Training 2022	29/09/2021
Team-NB Position Paper Implant Card	20/07/2021
TEAM-NB Member List	01/07/2021
CIRCABC RemoteAudit Analysis	10/06/2021
Team-NB-Position Paper ClassD V4.4	19/05/2021
Survey-2020	15/04/2021
Team-NB-MD-Sector-Survey-PressRelease-20210414	14/04/2021

Documents 2020

Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012	01/12/2020
Team-NB-PositionPaper-RemoteAudits-20201118	18/11/2020
TEAM-NB Member-List-28	07/09/2020
Team-NB Position Paper TCP V1	22/07/2020
TEAM-NB List of on line check for validity of certificates	14/05/2020
Survey-2019	05/05/2020
Team-NB MD Sector Survey PressRelease 20200505	05/05/2020
Team-NB Statement MDR DoA postponement 20200428	28/04/2020
Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745”	01/04/2020
Team-NB-Statment on Covid 19 – 20200312	12/03/2020
Team-NB-Position paper on Dental Implants-20200311-V1	11/03/2020

Documents 2019

Code of Conduct Medical Notified Bodies-V4-0	30/10/2019
Team-NB MD Sector Survey PressRelease 20190524	24/05/2019
Survey-2018.pptx	21/05/2019
Team-NB Press Release Survey Capacities February	28/02/2019
Joint NB Spinal Classification Decision Tree_final	28/01/2019
Team-NB Press Release IVDR Applications Survey 20190117	17/01/2019

Documents 2018

Team-NB Press Release Applications Survey 20181218	18/12/2018
White Paper-One Year of Application	26/11/2018
Team-NB-PositionPaper 20181124	24/11/2018
TEAM-NB Contact Transfer-NB	19/09/2018
Team-NB Press Release July Survey Capacities 20180820	20/08/2018
Team-NB MD Sector Survey PressReleas	26/04/2018
Team-NB sector survey in 2017	26/04/2018
Team-NB-Press-Release-Applications-Survey-20180214	14/02/2018

Documents 2017

Team-NB-MD-Survey-PressRelease-20170413	09/05/2017
Team-NB sector survey in 2016	04/05/2017
Leadless cardiac pacemaker therapy : new guidance from an MHRA Expert Advisory Group	20/03/2017

Documents 2016

TEAM-NB Press Release	07/07/2016
TEAM-NB-MD Survey 2015.pptx	10/05/2016
New version 3.4 of Code of Conduct	15/03/2016

Documents 2015

TEAM-NB Report Meeting PermRep NL	10/12/2015
Team-NB NB-Med Report	13-14/10/2015
MDRF Report	26/08/2015
MDEG Report	28/05/2015
TEAM-NB-Contact-Transfer-NB	22/05/2015
TEAM-NB-MD Survey 2014.pptx	14/01/2015
New Version 3.3 of Code of Conduct	14/01/2015