MDCG publishes new MIR and FSCA reporting forms – streamlined system for serious incident and FSCA reporting

In May 2025, the European Commission released revised templates for post-market surveillance and vigilance (PMSV), covering the Manufacturer Incident Report (MIR) and Field Safety Corrective Action (FSCA). These updates aim to help manufacturers comply with Articles 87–89 of the MDR and improve compatibility with the Eudamed database. The revision supports broader efforts in digitalization and harmonization of market surveillance across the EU.

Key changes to the MIR and FSCA forms

• Unified structure, forms adapted to XML format for easy electronic data submission.
• Updated code dictionary, new codes for issues, device types, and corrective actions in line with Eudamed terminology.
• Reduced mandatory sections, more intuitive layout and logical content structure.
• New FSN field, mandatory attachment of Field Safety Notice for end-users.
• Greater data precision, includes fields for clinical use code, incident location, user type, and patient impact.

Manufacturer obligations – updating the QMS

Although the new forms are labeled as recommended, in practice they are expected to be mandatory for notified bodies and national competent authorities. Manufacturers should:

• Update PMS and FSCA procedures within their QMS (according to ISO 13485:2016 and MDR Article 83).
• Ensure staff responsible for incident reporting are trained in the new form structure and documentation (e.g., study data, FSNs).
• Align IT systems to the required XML submission format if direct reporting to Eudamed is planned.
• Implement the new forms no later than Q3 2025, as full enforcement across Member States is anticipated.

Impact on notified bodies and competent authorities

Notified bodies will assess PMS compliance against the new reporting structure. National authorities will verify completeness and accuracy, so manufacturers must:

• Properly link each report to the UDI-DI.
• Confirm whether FSCA also qualifies as a serious incident (“dual submission”).
• Ensure consistency between MIR content, clinical evaluations, and risk analyses.

Relevance to the EU market

Standardized forms are a step toward full interoperability in Eudamed, improving risk response and increasing regulatory transparency. Harmonized PMSV reporting may also facilitate mutual recognition between the EU and international partners (e.g., USA, Switzerland, Canada), advancing global regulatory alignment.

See more: PMSV Reporting forms MDCG