The Manufacturer Incident Report (MIR) Form v7.3.1 is the official European Union template used for reporting serious incidents involving medical devices under the MDR/IVDR framework. Mandatory as of November 2025, this form collects detailed administrative, device-specific, and clinical data, including manufacturer identity, device categorization, incident description, health effects, and the manufacturer’s analysis. It uses IMDRF coding standards to ensure consistency across jurisdictions. The PDF version of the MIR is password-protected, and unlocking it may be necessary for specific purposes such as translation or integration into in-house systems—users must request access for such modifications.
