TEAM-NB Position Papers

TEAM-NB (Team of Notified Bodies) is the European association of medical device notified bodies. Their position papers provide harmonized Notified Body expectations for MDR/IVDR implementation.

Source

TEAM-NB Documents · Position Papers List (PDF)

Position Papers

Document	Date
Demonstration of Safety and Performance for Combinatorial Use of Devices or Equipment	2026-02
Annex VII	2025-12
IVD SARS-CoV-2 Down-Classification	2025-12
MDR Application and Appropriate Surveillance — Transfer Agreement	2025-10
IVDR Significant Changes V2	2025-10
Best Practice Guide — IVDR V2	2025-09
Orphan IVDR Medical Devices	2025-07
Software Qualification under the IVDR V2	2025-06
IVDR Certification Process Consensus Document	2025-04
EU AI Act V2	2025-04
Best Practice Guide — Technical Documentation EU MDR V3	2025-04
MDR Certification Process Consensus Document	2024-12
Joint Team-NB / IG-NB — AI in MD Questionnaire V1.1	2024-12
IVD Transfer Agreement	2024-09
Transfer Agreement V2 (with instructions)	2024-07
Lifetime of a Medical Device	2023-11
Legacy MD Surveillance Transfer Agreement V1	2023-08
MDR Transition Timelines — Notified Body Capacity V1	2023-08
NB Confirmation Letter EU 2023/607 V2	2023-07
Hybrid Audits V2	2023-05
MDCG 2022-14 Item 17 — Certificates under Conditions	2022-11
Voluntary Transfer Agreement V1	2022-10
Cybersecurity V1	2022-10
Off-Label Use V1	2022-10
Conformity Assessment — Multiplex Assays V1	2022-07
Modifications to Sampling Plan V1	2022-01
MDR/IVDR Implementation V3	2021-12
Article 117 — NB Opinion Template V1	2021-10
Artificial Intelligence V1	2021-10
Implant Card	2021-07
Class D Conformity Assessment V4.4	2021-05
Article 117 — Substantial Changes Drug-Device Combination	2020-12
Remote Audits V1	2020-11
Technical Compliance Process (TCP) V1	2020-07
Documentation Requirements Article 117 V1	2020-04