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Commission publishes new mandatory manufacturer incident report (MIR) under MDR/IVDR

Published on: 07 May 2025
Published by LNB News

LNB News 07/05/2025

Document Information

Issue Date: 07 May 2025

Published Date: 07 May 2025

Jurisdiction(s): European Union

Article summary

The European Commission has released an updated Manufacturer Incident Report (MIR) form version 7.3.1 to align with the requirements under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746(IVDR). The updated version of MIR is effective May 5, with mandatory compliance by November 2025. Key regulatory changes include enhanced reporting requirements, with new fields capturing the date of manufacturer awareness regarding reportability and adjustments to device identification, ensuring proper classification, especially for legacy devices. A detailed help guide is available to assist manufacturers in understanding the new fields and ensuring compliance with the updated requirements.

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