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Manufacturers of medical devices must report serious incidents using a new form starting May 2026
The European Commission has published a new version (7.3.1) of the Manufacturer Incident Report (MIR) form. Manufacturers of medical devices and IVDs must start using the reporting form by May 2026, at the latest.
Using the MIR form, manufacturers report serious incidents to the competent authority of the member state where the incident occurred.
The manufacturer has the primary responsibility for ensuring that a device meets regulatory requirements and is safe and efficient throughout its lifecycle. Serious incidents must be reported without delay and the related investigations carried out in an appropriate manner.
The reporting form version 7.3.1 and the related up-to-date guidance on the information to be provided in the form are available on the European Commission’s website.
More information
Commission website: PMSV reporting forms
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