Key Updates in MDR & IVDR: Transition from MIR 7.2.1 to 7.3.1 for Incident Reporting

Version 7.2.1 of the MIR form was widely used under MDR and IVDR. It allowed manufacturers to report device-related incidents and field safety corrective actions. Notably, various regional adaptations existed, like MIR schemas specific to the UK and Switzerland.

Key Features:

• A modular layout that includes sections for administrative, device, and incident details.
• XML schemas for easier digital submissions.
• Used for both initial and follow-up incident reports.

What's New in MIR 7.3.1?

The MIR 7.3.1 is the latest version of the manufacturing incident Report form published by the European Commission in May 2025.MIR 7.3.1 introduces significant changes to help manufacturers comply with regulation, data collection, and to enhance reporting accuracy. It will be mandatory in the EU and Switzerland from November 2025, with a transition period until then.

Major Updates & Improvements from the previous MIR 7.2.1 are:

Mandatory Data Coding

All reports must use the IMDRF coding system as outlined in Annexes E & F for all reports. Annex G is required for final reports.

Enhanced Data Fields

• Device description and nomenclature are now in separate fields.
• Manufacturers can now indicate if a legacy product is still marketed post-MDR/IVDR.
• Separated fields for manufacturer’s awareness date (incident) and reportability, as per MDCG 2023-3.

Regulatory and Territorial Adjustments

• UK and Switzerland removed from EEA distribution list but Northern Ireland added.
• Swissmedic adoption of MIR 7.3.1 for Switzerland which will becomes mandatory from November 2025.

Technical Improvements

• Direct XML saving and better email submission options.
• XSD and XSL files for easier database and system integration.

Refined Reporting Logic

• New fields for device typing and identification of similar incidents.
• Clearer guidance on what constitutes a serious incident and manufacturer reporting responsibilities.

Impact and Next Steps for Manufacturers

Transition Period: MIR 7.2.1 can still be used until November 2025, but manufacturers must update internal processes to comply with MIR 7.3.1 requirements.

Internal Changes Needed:

• Revise incident reporting workflows and staff training.
• Integrate new coding standards and data fields into relevant systems.
• Pay attention to geopolitical updates impacting market distribution fields.

GB MIR Form Update:

The GB MIR form is a specialized electronic report for medical device incidents required in Great Britain, aligned with the updated post-market surveillance regulations introduced in 2024 and implemented through the MHRA’s MORE (Manufacturer’s Online Reporting Environment) portal.

How the GB MIR System Works

Online Platform: Reports are submitted via the MHRA’s MORE portal, which supports webform entry, XML uploads, and API integrations for automated submissions.

Schema and Structure Updates: The GB MIR schema has been modernized, improving the structure and completeness of incident data and allowing easier IT system integration for manufacturers.

Mandatory Reporting: Manufacturers and their UK Responsible Persons must use this form to report incidents and field safety corrective actions (FSCAs) that occur in the UK, as well as adverse events and trends. The MHRA also allows v7.2.1 of the EU MIR form to be used (with GB-specific data) for a four-month transition period until 16th October after which MHRA will only accept reports conforming to the GB-specific (7.2.1) MIR form

Key Changes and Distinctions

Separate GB and EU Requirements: GB MIR is separate from the EU MIR (currently v7.3.1), with its own technical schema and reporting requirements. Systems integrated with the MORE portal must update to the latest GB schema for compliance as of summer 2025.

Improved Data Quality: The new reporting format supports better trend detection, risk signal recognition, and overall transparency for patient safety.

Multiple Submission Channels: The MORE portal accommodates both manual web form completion and direct XML/API data transmission for efficiency in high-volume submissions.

Steps for Manufacturers

Register on the MORE Portal: Organizations must appoint an “Organisation Lead” who manages access for standard users and responsible persons.

Update IT Systems: Manufacturers with integrated reporting (via XML/API) must ensure their systems are aligned to the updated GB MIR schema.

Review MHRA Guidance: Official schema implementation guides and technical documents are provided on the MHRA website for step-by-step compliance.

Ongoing EU/NI Reporting: For incidents in Northern Ireland or the EU, continue using the appropriate EU reporting platforms and forms.

The move to an upgraded GB MIR form and process highlights the UK’s commitment to up-to-date, robust medical device surveillance, aiming for enhanced safety and regulatory clarity in the post-Brexit environment.

Key Considerations:

• New Post-Market Surveillance (PMS) Regulation
• Fast-tracked reporting: The required reporting timeline for serious incidents has decreased from 30 to 15 days.
• New PMS obligations: Manufacturers must actively collect and evaluate post-market data and report any notable increases in incident frequency or severity.
• Online Reporting via the MORE Portal

Submissions of MIR and FSCA forms must be made through the MHRA’s MORE system. These methods include direct web form entry, XML uploads, or APIs.

Comparison: MIR 7.2.1, MIR 7.3.1, and GB MIR

Understanding the distinctions between MIR 7.2.1, the newly released MIR 7.3.1, and the GB MIR form is essential for manufacturers reporting medical device incidents in the EU and Great Britain.

Conclusion

MIR 7.2.1 is being phased out in favour of a stricter, more standardized MIR 7.3.1 in the EU. MIR 7.3.1 represents a major advancement in EU medical device post-market vigilance. It maximizes data clarity, enables better oversight, and helps manufacturers meet evolving regulatory demands.

The GB-specific MIR update streamlines incident reporting, enhances data quality for medical device vigilance, and aligns regulatory frameworks with new post-market surveillance demands.

Manufacturers should review field-level requirements and update their workflows and IT systems to ensure compliance with whichever jurisdiction their products are placed in. Manufacturers must act now to transition by autumn 2025 to remain compliant.

For further guidance and support reach out to Sushvin consultants for MDR/IVDR incident reporting requirements. With over 14 years of experience, we at Sushvin Consultancy Services, are dedicated to guiding medical device companies through the intricate landscape of global regulations. We provide customized and cost-effective solutions that ensure compliance with international standards for medical devices and in-vitro diagnostics.

We specialize in Quality Assurance and Regulatory Compliance and our team possesses deep knowledge across various sectors, including Advanced Wound Care, Software as a Medical Device (SaMD), Dental Implants, Orthopedics, Drug-Device Combination Products, and In Vitro Diagnostics.

Reference

1. New Manufacturer Incident Report (MIR) form in EU - MDlaw

2. Major Update for Medical Device Manufacturers – MIR Form 7.3.1

3. GB MIR and FSCA schema implementation guide - GOV.UK

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