New question-and-answer document on reporting serious incidents with medical devices

New question-and-answer document on reporting serious incidents with medical devices

New question-and-answer document on reporting serious incidents with medical devices

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May 26, 2020 - Cosmetics

New question-and-answer document on reporting serious incidents with medical devices

New question-and-answer document on reporting serious incidents with medical devices

Since January 2020, manufacturers of medical devices have been required to use a specific EU template for reporting incidents to the BfArM.

This template is called the MIR-Template (Manufacturer Incident Report). The European Commission has now published a Questions and Answers (Q&A) document regarding this template in May.

This document is intended to assist companies in adapting their IT systems to the new MIR form. Furthermore, it explains additional developments, especially with regard to the transition to the MDR / IVDR regulation and the new Eudamed database.

If you have any questions regarding legal requirements & marketing of medical devices, please feel free to contact us. The experts at the BAV Institute, part of the international Tentamus laboratory group, are happy to assist you.

The new document is freely available at ec.europa.eu.