Insights

The update to the Manufacturer Incident Report (MIR) Form 7.3.1, published on 18 July 2025, introduces significant changes to the Medical Device Regulation (MDR), with a focus on reporting serious incidents. These updates are essential for ensuring the safety and traceability of medical devices in the European market.

The MIR serves as a critical tool for manufacturers to report serious incidents involving medical devices. The updated form provides a streamlined process for incident reporting, with clear specifications on the required data. Key changes include modifications to device classifications, the management of post-market surveillance (PMS) data submission timelines, and an increased emphasis on transparency and timeliness in reporting.

The updated MIR Form 7.3.1 simplifies the submission process and enhances the overall efficiency of regulatory practices. Manufacturers must align their practices with the new requirements to avoid non-compliance and ensure the continued safety of their devices.

RPN will provide any further update and is available to provide full support for vigilance activities on medical devices.