New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

The European Commission has released a new version of the Manufacturer Incident Report (MIR) form-MIR 7.3.1-which will become mandatory for all medical device and IVD manufacturers from November 2025. This update is a significant step in harmonizing and streamlining incident reporting processes across the European Union, in line with the MDR and IVDR requirements.

MedNet EC-REP

Author

05. Mai 2025

What’s New in MIR 7.3.1?

The new MIR form is available as a password-protected PDF. Manufacturers needing to translate the form or integrate it into their internal systems can request the password for authorized uses.
Alongside the PDF form, the European Commission has published XSD and XSL files. These technical resources are designed to help manufacturers implement the MIR format directly into their databases, facilitating digital reporting and data management.
A comprehensive helptext and a detailed changelog are provided to guide users through the new form and highlight the latest modifications.

Implementation and Technical Requirements

The MIR 7.3.1 PDF form requires Adobe Acrobat Professional for electronic signing and for XML data import/export functionalities. This ensures both security and compatibility with regulatory systems.
It is recommended to save the form locally and open it from your computer, as some browser plugins may not be compatible with the advanced features of the PDF form.

Why This Matters for Manufacturers

The introduction of MIR 7.3.1 reflects the EU’s ongoing commitment to improving post-market surveillance and vigilance reporting. By standardizing incident reporting, the new form aims to:

Enhance the quality and consistency of incident data collected from manufacturers.
Support the timely identification of safety issues and trends.
Facilitate compliance with MDR and enable better oversight by competent authorities.

Support for Manufacturers

MedNet EC-REP GmbH is dedicated to assisting medical device and IVD manufacturers in adapting to these regulatory changes. For questions about the new MIR form, Eudamed requirements, or compliance strategies, manufacturers are encouraged to contact MedNet EC-REP’s regulatory experts.

Further Information

The new MIR form and supporting documentation can be accessed on the official European Commission website under PMSV reporting forms. Manufacturers should ensure they are prepared for the November 2025 deadline and update their internal processes accordingly. MedNet EC-REP GmbH remains committed to supporting the medical device industry through regulatory change and ensuring patient safety across Europe.

Amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union.

Regulatory Updates

EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers

In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.

MedNet EC-REP18. Juni 2026

Regulatory Updates

New swissdamed registration fees - what manufacturers need to know from 2027

From 1 July 2026, all medical devices placed on the Swiss market must be registered in the national swissdamed database. Together with this registration obligation, the Swiss Federal Council has approved a revised Swissmedic fee ordinance introducing a product registration fee. The first invoices will be issued in January 2027. Here is what to expect.

MedNet EC-REP15. Juni 2026

erstelle ein bild auf dem keine personen abgebildet werden. Das bild muss zu diesem Artikel passen: eIFUs – How to benefit as professional-use device manufacturer?
EU Expands eIFU Eligibility for Professional-Use Devices under Commission Implementing Regulation (EU) 2025/1234
The regulatory framework for electronic Instructions for Use (eIFU) in the European medical device sector continues to evolve. With the adoption of Commission Implementing Regulation (EU) 2025/1234, the European Commission has expanded the categories of medical devices that may provide instructions for use in electronic form (https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj/eng).
For manufacturers of medical devices and in-vitro diagnostics (IVDs), this amendment to Commission Implementing Regulation (EU) 2021/2226 represents an important step toward digital product documentation, while maintaining the safety principles established under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.
eIFU Remain Limited to Professional-Use Devices
A key regulatory principle remains unchanged: electronic instructions for use may only replace paper instructions for devices intended exclusively for professional users.
Devices intended for lay users, home-use diagnostics, or consumer healthcare applications must continue to include paper instructions for use. Manufacturers must therefore carefully evaluate the intended user group and foreseeable use scenarios during regulatory classification and risk management.
Regulatory Requirements under MDR and IVDR
Both MDR and IVDR define general obligations regarding the information supplied with medical devices and IVDs.
Key provisions include:
MDR Article 10(11) and Annex I Chapter III, 23
IVDR Article 10(10) and Annex I Chapter III, 20
These sections require manufacturers to ensure that instructions for use are:
clear and understandable
accessible to the intended user
kept up to date throughout the device lifecycle.
In addition, the norm EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer is useful as support for the preparation of the instruction for use.
A Key Advantage: Managing EU Language Requirements
One of the most practical advantages of eIFU is the simplified management of national language requirements across the EU.
Under MDR and IVDR, instructions for use must be provided in the official language(s) required by each Member State where the device is made available. (See EU overview of language requirements https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en)
For manufacturers distributing devices in multiple EU markets, this often means maintaining a large number of translated IFU versions.
A compliant eIFU platform enables manufacturers to:
host all required translations in one central location
provide immediate access to the correct language version
update individual translations without reprinting entire manuals.
If all required translations are available electronically, manufacturers can more efficiently meet EU language compliance obligations while avoiding complex logistics related to multilingual printed instructions.
Operational Benefits of eIFU
Beyond language management, eIFU offer several additional advantages for Regulatory Affairs and Quality teams.
Faster safety updates
Electronic IFU allow manufacturers to publish updated instructions immediately after regulatory approval.
Improved document control
Digital platforms support version tracking, traceability, and archived access to previous IFU versions.
Sustainability and logistics efficiency
Reducing printed documentation decreases packaging volume and environmental impact.
Key Compliance Considerations
Despite these benefits, manufacturers must address several regulatory requirements.
Risk Assessment
The manufacturer must perform a documented risk assessment to show that providing IFUs electronically maintains or improves safety compared with paper.
Availability and Access
eIFUs must be available in all EU Member States where the device is placed on the market, unless justified otherwise in the risk assessment.
They must be accessible on a website or electronic medium and provided in a commonly used format that can be read with freely available software.
Website Requirements
Websites used to host eIFUs must meet the following conditions:
Protected against unauthorized access and tampering.
Stable internet address, directly accessible.
Must fulfil data protection requirements (GDPR).
Ensure minimal server downtime and display errors.
Request for Paper Version
Even if IFUs are delivered electronically, manufacturers must have a system to provide a paper version at no extra cost upon user request, normally within 7 calendar days of request.
Labeling
Manufacturers must clearly indicate on the device label or packaging that instructions are supplied electronically and provide information on how to access them.
Retention and Versions
eIFUs must be retained in electronic form for specified periods after the device is last placed on the market:
10 years for devices with a defined expiry date (except implantable).
15 years for implantable devices or devices without a defined expiry date.
Historical versions (including publication dates) must be accessible on the website or, if obsolete, available on request.
Connection to UDI and Eudamed
Once Eudamed’s UDI database registration becomes mandatory, the manufacturer must provide the internet address (URL) where the eIFU is accessible to the database.
Conclusion
The updated EU eIFU framework expands opportunities for digital instructions for use across the medical device sector. However, manufacturers must ensure strict compliance with regulatory conditions—particularly the requirement that eIFU replacing paper instructions are only permitted for devices intended exclusively for professional users.
When implemented correctly, eIFU not only support regulatory compliance under MDR and IVDR but also provide a significant advantage in managing multilingual documentation across the European market.

Regulatory Updates

EU Expands eIFU Eligibility: Key Changes under Implementing Regulation (EU) 2025/1234

The EU expands the use of electronic Instructions for Use (eIFU) for professional-use medical devices under Implementing Regulation (EU) 2025/1234. Key compliance considerations for MDR and IVDR manufacturers.

MedNet EC-REP18. Mai 2026

New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

What’s New in MIR 7.3.1?

Implementation and Technical Requirements

Why This Matters for Manufacturers

Support for Manufacturers

Further Information

Related Articles

EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers

New swissdamed registration fees - what manufacturers need to know from 2027

EU Expands eIFU Eligibility: Key Changes under Implementing Regulation (EU) 2025/1234

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