On 5 May 2025, the European Commission released an updated version of the Manufacturer Incident Report (MIR) form (version 7.3.1). This version will become mandatory for all incident reporting under the Medical Devices Regulation (MDR) and in-vitro diagnostic medical devices regulation (IVDR) as of November 2025.
The form is password-protected. Manufacturers may request the password for authorised purposes, such as integrating the form into internal systems or translating it for internal use.
Alongside the updated form, the Commission has made available:
- XSD and XSL files to facilitate database implementation
- A helptext document to support completion of the form
- A changelog file detailing modifications from previous versions
Structure of the MIR 7.3.1 Form
The form retains a modular structure and is composed of the following key sections:
- Administrative Information
Includes the manufacturer’s name, SRN, and contact details. - Device Identification
Covers UDI-DI/UDI-PI, device name, model, and risk classification. - Incident Description
Requires a description of the incident, timeline, and reported problem. - Consequences of the Incident
Documents any actual or potential harm to patients, users, or third parties. - Investigation and Risk Evaluation
Includes information on root cause analysis, corrective or preventive actions, and manufacturer’s conclusions. - Distribution and Market Information
Requires data on the geographical scope of distribution and the number of affected devices. - Attachments
Space to reference or include supporting documents or additional observations.
Technical notes regarding the updated MIR
Adobe Acrobat Professional is necessary for completing and digitally signing the form, as well as for XML import/export functions. Some browser-based PDF viewers may not support interactive features. It is recommended to download and open the form locally.
Manufacturers should ensure their internal processes and reporting systems ahead of the November 2025 deadline.
Do you have questions on MDR and IVDR? Contact us here or at mdlaw@obelis.net.
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