Version 7.3.1 en 2020-05-15
Medical Devices Vigilance System
Mandatory as from November 2025
Replaces MEDDEV 2.12-7 rev. 7.2.1
Archives: Downloads
Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR)
Version 7.3.1 en 2020-05-15
Medical Devices Vigilance System
Mandatory as from November 2025
Replaces MEDDEV 2.12-7 rev. 7.2.1
Team-NB Position Paper on European Artificial Intelligence Act
IVDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
MDR Technical documentation
Reclassification IVD COVID Tests
Press Release
Team NB
WG/N14FINAL:2025 (Edition 5) PMS National Competent Authority Report Exchange Criteria and Report Form
MDCG 2020-16 Guidance classification IVDR rev. 4
EU 2017/746 In-vitro Device Regulation (2025-01-10)
IVDR
2023/607
2024/1860
WG/N43FINAL:2020 Adverse Event Report Terminologies for Reporting – Annex A-G updated in 2025
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes. Appendices A – G 2025
IMDRF