December 11, 2025

The European Commission has quietly updated its post-market surveillance and vigilance (PMSV) webpage, signaling an upcoming revision to the Manufacturer Incident Report (MIR) form. While MIR Version 7.3.1 was originally expected to be implemented in 2025, the EC now indicates that a new revision will be released, and mandatory use will begin four months after publication.

Based on current developments, industry expectations point to earliest enforcement around March 2026, a significant delay compared to prior assumptions.

Manufacturers placing devices on the EU market under MDR (2017/745) must closely track these updates due to the MIR form’s central role in serious incident and field safety corrective action reporting.

Background: Why a New MIR Form Was Needed

The MIR Version 7.2.1, in place since 2020, needed updates due to multiple system and regulatory changes:

1. EUDAMED Integration Requirements

The transition to electronic vigilance submissions required new data fields, standardized XML structures, and harmonized reporting logic.

2. Post-Brexit Adjustments

U.K. exits required removal or modification of legacy references to EU conformity pathways.

3. Expiration of the EU–Switzerland MRA

The end of mutual recognition with Switzerland required updated regulatory representation and market access fields.

The MIR 7.3.1 form was meant to address these gaps—but its rollout revealed significant usability challenges.

Technical Challenges with MIR Version 7.3.1 (Including SB 10573 Revision)

Numerous manufacturers and authorized representatives reported operational failures with Version 7.3.1, including:

1. Data Retention Failures (Section 2.5a)

  • Distribution data entries would not be saved correctly, even with Adobe Acrobat Pro.
  • Resulted in repeated work, submission errors, and lost field data.

2. Annex A Selection Errors (Section 4.3.1a)

  • Users could not select only Annex A when identifying similar serious incidents.
  • This posed compliance challenges for devices with narrow incident histories.

3. Functionality Issues Despite Using Required Software

  • Even users with Adobe Acrobat Pro—mandatory for the form—reported:
    • Field locking
    • Inability to validate sections
    • From crashes
    • Auto-population errors

4. Workflow Disruptions for ARs and Manufacturers

  • Cross-team review became problematic due to an inconsistent form of behavior.
  • Validation failed in several areas despite accurate data entry.

These issues demonstrate that MIR 7.3.1 is not currently functional for widespread use.

Lack of Official Communication Creates Ambiguity

Apart from subtle changes to the EC PMSV webpage, no formal notice has been issued regarding:

  • Known MIR 7.3.1 defects
  • Expected fixes
  • Revised implementation dates
  • Clarification for manufacturers and Authorized Representatives
  • Updated guidance documents

Although the MDCG PMSV Working Group has convened to address these issues, no official announcement has been published.

This information vacuum has created uncertainty for manufacturers preparing MIR reporting workflows for MDR compliance.

What Manufacturers Should Expect Next

1. A Third Draft of MIR 7.3.1 Is Under Development

A revised version is expected before the end of 2025.

2. Mandatory Implementation Will Begin Four Months After Publication

Based on current indicators:

  • Publication likely in late 2025
  • Enforcement window begins ~March 2026

3. Continued Use of MIR 7.2.1 Is Recommended

Until the new version is validated and issues are resolved, MIR 7.2.1 remains the safest and most stable option.

Impact on MDR Post-Market Surveillance and Vigilance

Delays in the MIR update affect several aspects of EU compliance:

1. EUDAMED Vigilance Module Preparation

Manufacturers must adjust timelines for preparing XML-ready vigilance reports.

2. AR and Importer Reporting Obligations

Authorized Representatives must stay aligned with MDR Article 11 obligations, especially regarding reporting accuracy.

3. Response Planning for Competent Authority Queries

Inconsistent MIR functionality complicates incident documentation and investigation reporting.

4. Harmonization of PMSV Processes Across the EU

Organizations may need to update SOPs once the new MIR form is finalized.

Recommended Actions for Manufacturers (2024–2026)

1. Continue using MIR Version 7.2.1 until further notice

Remains aligned with stable reporting processes.

2. Monitor EC and MDCG publications weekly

Ensure readiness for the revised MIR release.

3. Update internal vigilance SOPs with flexibility built in

Allow for rapid transition once the new form is published.

4. Validate Adobe software configurations across all quality teams

Minimize technical errors when the next version is released.

5. Prepare EUDAMED-ready data structures

The eventual MIR update will require structured vigilance submissions.

6. Strengthen AR/manufacturer collaboration

Coordinate early to avoid data discrepancies.

Conclusion

The European Commission’s evolving updates indicate that MIR Version 7.3.1 will not be implemented in 2025, with mandatory use expected no earlier than March 2026.
 Given the significant usability and technical issues in the current version, a full redesign is underway.

For manufacturers, the best course is to:

  • Continue using MIR 7.2.1
  • Monitor EC and MDCG communications
  • Prepare internal processes for rapid adoption of the next MIR revision

This transition represents a key shift in MDR vigilance reporting, and proactive readiness will reduce compliance risk.

How Maven Regulatory Solutions Supports MDR Vigilance Compliance

Maven Regulatory Solutions delivers end-to-end support for EU vigilance and MDR PMS requirements.

Our Expertise Includes:

  • EU MDR vigilance reporting strategies
  • MIR form completion and submission support
  • EUDAMED vigilance readiness
  • Authorized Representative liaison guidance
  • SOP development for PMSV workflows
  • Incident investigation documentation
  • Regulatory intelligence tracking for EC/MDCG updates

Our teams ensure manufacturers maintain continuous, audit-ready EU vigilance compliance during this transition.