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2021-2226 Electronic instructions for use of medical devices + amendment ((EU)2025-1234 of June 26, 2025))
MDR
(EU) 2025-1234
Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) (helptext)
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
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