Since the entry into force of Regulation (EU) 2021/2226 at the beginning of 2022, manufacturers have been permitted, under certain conditions, to provide instructions for use for medical devices in electronic form (eIFU). With Regulation (EU) 2025/1234, the European Commission has further developed the original framework and expanded the scope of eIFU requirements.
As a result, MedTech companies now have new opportunities for the digital provision of product information. At the same time, requirements related to UDI data management, EUDAMED integration, and the long-term availability of electronic instructions for use are increasing. In this article, you will learn what changes Regulation (EU) 2025/1234 introduces, which eIFU requirements manufacturers and website operators must fulfill, and what role EUDAMED will play in the future.
From Regulation (EU) 2021/2226 to 2025/1234
Regulation (EU) 2025/1234 builds upon and further develops the existing provisions of Regulation (EU) 2021/2226. Recent changes are driven by the increasing digitalization of healthcare and practical experience gained from implementing the previous rules.
The new regulation adds to the existing eIFU requirements and adapts the regulatory framework to current market demands. The provisions of Regulation 2021/2226 remain in force but are expanded. For MedTech companies, this means greater flexibility in providing electronic instructions for use. At the same time, eIFU processes are becoming more closely integrated into established regulatory workflows.
What Changed in 2025
With the amending Regulation (EU) 2025/1234, eIFU requirements have been significantly expanded while also being simplified. The electronic provision of instructions for use is no longer limited to selected product categories. In the future, in principle, all MDR-covered products intended for professional users may benefit from these provisions.
In addition, products listed in Annex XVI of the MDR that do not have a medical purpose are now included, provided they are intended for professional use. A paper version of the instructions for use is still required if a product intended for professionals is also likely to be used by laypersons. An exception applies where the medical device is software and the instructions can be displayed directly within the software itself.
Another important change is the obligation to register the internet address of the electronic instructions for use in EUDAMED’s UDI database. This requirement becomes applicable once the corresponding registration obligation takes effect. For many manufacturers, this creates a closer connection between eIFU, UDI, and EUDAMED processes.
eIFU Requirements for Manufacturers
Manufacturers wishing to use electronic instructions for use must comply with various regulatory requirements. One of the most important obligations is conducting a documented risk assessment. This assessment must demonstrate that the electronic instructions for use provide at least the same level of safety as a paper version.
Manufacturers must also ensure that paper instructions for use are supplied free of charge upon request within seven calendar days. Electronic instructions must contain at least the same information as the printed version. Furthermore, they must be available in the required official EU languages and archived for defined periods. This means:
- An eIFU must remain available until whichever is later: 10 years after the last device has been placed on the market, or 2 years after the expiration date of the last device placed on the market.
- eIFUs for implantable devices, or for devices without an expiration date, must remain available for 15 years after the last device has been placed on the market.
In addition, manufacturers must clearly indicate how users can access the eIFU. Relevant UDI information and manufacturer contact details must also be provided. Any safety-related changes to the instructions for use must be communicated in a transparent and traceable manner.
Overview of Key Requirements
| Requirement | Responsible Party |
| Conduct a documented risk assessment for the use of electronic IFUs | Manufacturer |
| Demonstrate that the electronic IFU provides at least the same level of safety as a paper IFU | Manufacturer |
| Provide electronic IFUs in the Member States where the product is available | Manufacturer |
| Supply a paper IFU free of charge upon request within the specified timeframe, no later than 7 calendar days | Manufacturer |
| Provide information for medical emergency situations and device start-up procedures (for products with an integrated display) | Manufacturer |
| Ensure the correct design and functionality of electronic IFUs | Manufacturer |
| Provide the IFU in the official EU language required by the respective Member State | Manufacturer |
| Provide information on how to access the electronic IFU | Manufacturer |
| Display UDI information and manufacturer contact details when accessing the IFU | Manufacturer |
| Submit the URL of the electronic IFU to the UDI database (EUDAMED) once UDI registration becomes mandatory | Manufacturer |
| Ensure the website is protected against unauthorized access and tampering | Manufacturer / Website Operator |
| Minimize website downtime and display errors | Manufacturer / Website Operator |
| Ensure compliance with GDPR requirements | Manufacturer / Website Operator |
eIFU Requirements for Websites and Digital Distribution
Not only manufacturers but also operators of eIFU platforms must comply with several requirements. Websites used to provide electronic instructions for use must be protected against unauthorized access and tampering. In addition, they must comply with the requirements of the General Data Protection Regulation (GDPR).
A high level of technical availability is equally important. Server outages and display errors should be minimized wherever possible. The internet address of the eIFU must remain reliably accessible throughout the required retention periods.
Furthermore, both current and historical versions of the instructions for use must be available in accordance with regulatory requirements. The goal is to ensure reliable and long-term access to safety-related product information.
EUDAMED and eIFU from a Single Source
With the new requirement to register eIFU information in EUDAMED, centralized data management is becoming increasingly important. Companies that upload their product data to EUDAMED using the mytracekey UDI Manager can significantly simplify their eIFU processes.
Electronic instructions for use can be assigned to the corresponding products simultaneously through the mytracekey eIFU App. This enables UDI data and eIFU information to be managed within a single integrated system.
As a result, manufacturers benefit from an end-to-end process covering everything from product registration to the provision of electronic instructions for use. The combination of the mytracekey UDI Manager and eIFU App helps optimize regulatory workflows, eliminate data silos, and maintain product information centrally. This improves efficiency in product data management and enables organizations to meet UDI and eIFU requirements without relying on additional system providers.
Seamless Integration of eIFU and UDI Management
The new eIFU requirements demand close integration between instructions for use and UDI data. With the mytracekey UDI Manager and eIFU App, both can be managed within a centralized platform, allowing electronic instructions for use to be easily linked to registered products. Learn more about the eIFU App via the following link or book a spot for our eIFU demo.