In today’s digital world, the use of electronic instructions for use (eIFU) for medical devices is gaining prominence. The shift from paper-based to electronic formats aims to enhance accessibility, reduce environmental impact, and streamline device usage for healthcare professionals and patients. But what exactly is an eIFU, who can use it, and what are the regulatory requirements for implementing one?
This article will guide you through the essentials of eIFU, its requirements under EU Regulation 2021/2226, and the latest proposed changes to the legislation.
Bonus: At the end of the Article I will share with you the project we were working on to offer you the possibility to store your eIFU easily.
Introduction to eIFU for Medical Devices
What is an eIFU?
An electronic Instructions for Use (eIFU) is the digital version of the instructions for use (IFU) that accompany medical devices. Instead of printed paper leaflets, manufacturers provide these instructions in a digital format—such as a downloadable PDF, an online document, or an embedded interface within a device.
Why are eIFUs Important?
-
Faster Updates: Manufacturers can quickly update instructions, ensuring the latest safety and performance information is available.
-
Improved Accessibility: Healthcare professionals and patients can access instructions from multiple devices (computers, tablets, smartphones).
-
Environmental Benefits: Reducing paper waste and printing costs supports sustainability efforts.
-
User Convenience: Interactive elements like videos, hyperlinks, and multilingual content can improve comprehension.
eIFU Eligibility and Device Categories
Who Can Use an eIFU?
The current regulation (EU 2021/2226) specifies that not all medical devices can replace paper-based instructions with eIFUs. Only certain categories of devices qualify, primarily those used by healthcare professionals rather than end-users or patients.
Devices Eligible for eIFUs
eIFUs can be provided for:
-
Implantable medical devices
-
Fixed medical devices (e.g., MRI scanners, infusion pumps)
-
Professional-use devices that require immediate access to digital updates
-
Devices with integrated digital displays
Devices NOT Eligible for eIFUs
-
Home-use medical devices (e.g., blood glucose monitors, nebulizers)
-
Devices used in emergency situations (where immediate paper access is crucial)
-
Any device intended for non-professional users without internet access
In essence, if a device is used by a trained healthcare professional and can be accessed digitally without safety risks, an eIFU may be permitted.
What Are the Requirements to Put an eIFU in Place?
The European Commission Implementing Regulation 2021/2226 sets strict requirements for manufacturers before transitioning to eIFUs. Below are the key requirements:
eIFU Labeling and Access Information
Where Should I Place the Information About the eIFU?
If a device uses an eIFU, manufacturers must inform users clearly about how to access it.
Labeling Requirements
-
Device Label: The label must include a clear symbol or text indicating that the IFU is available electronically.
-
Packaging & Instructions: A QR code or web link should be provided for easy access.
-
Website & Digital Access: The eIFU must be hosted on a dedicated manufacturer’s website that meets regulatory compliance.
eIFU for Reusable Devices
For devices used multiple times (e.g., sterilizable surgical instruments), manufacturers should:
-
Include a permanent label on the device with an embedded access link.
-
Provide clear download instructions in case the website is unavailable.
How to Identify an eIFU for a Medical Device
How to Identify That an eIFU Is Available for a Medical Device?
For healthcare professionals and users to benefit from electronic instructions for use (eIFU), it’s not enough for the file to be digitally accessible. The manufacturer must clearly communicate that an eIFU is available and ensure it can be accessed quickly and reliably. This section outlines the regulatory requirements and best practices to help companies ensure their devices remain compliant under EU regulations.
Where Should the Availability of an eIFU Be Indicated?
To comply with the EU MDR 2017/745 and Implementing Regulation (EU) 2021/2226, manufacturers must inform users that instructions for use are provided in electronic format. This indication should be visible and documented on the following:
-
The label affixed to the device
-
The outer packaging of the device
-
The accompanying documentation, such as implant cards or delivery notes
-
The technical documentation and Declaration of Conformity
-
Any paper IFU that might be optionally provided or included
Furthermore, a paper version of the IFU must be made available upon request, free of charge, within a reasonable timeframe. This ensures that users who may not have easy internet access can still obtain the information they need.
How to Display the eIFU Availability
The best way to communicate the presence of an eIFU is through a symbol accompanied by a website URL or QR code that leads directly to the electronic instructions.
Which Symbol Should Be Used?
The internationally recognized symbol for eIFU is defined in the harmonized standard:
-
Standard: ISO 15223-1:2021 — Medical devices – Symbols to be used with information to be supplied by the manufacturer
-
Symbol: This symbol indicates that instructions for use are provided in electronic form
-
Reference: Clause 5.4.5 – “Electronic instructions for use”
This symbol may appear alone, but when used, it must also be explained in the “Explanation of Symbols” section of the IFU or in the symbol legend provided with the device.
Example of Label or Packaging Display:
The website or QR code must point directly to the correct IFU for the specific device model, version, and language.
eIFU Access and Compliance Requirements
Regulatory Requirements for eIFU Access
To meet compliance, manufacturers must ensure the eIFU is:
-
Freely accessible, without requiring account registration
-
Available in all official languages of the countries where the device is marketed
-
Available at the time of device use
-
Hosted on a secure server, ensuring data integrity and protection from unauthorized access or modification
-
Clearly version-controlled, with a documented change history
If QR codes are used, the label and website must remain valid for at least the expected lifespan of the product or a minimum of 10 years following the device’s last placement on the market (as aligned with MDR retention requirements).
Traceability and Documentation
In addition to external labeling, manufacturers must also document the presence and management of eIFUs within their internal systems:
-
Include eIFU accessibility details in the technical file
-
Document the eIFU process in the Quality Management System (QMS)
-
Validate the system used to generate and manage the eIFU content
-
Describe how users can obtain a printed copy on request
It’s also recommended to log all user feedback related to eIFU accessibility and to include a corrective action plan in case of system failure or access disruption.
What Are the Content of the New Proposal for Change of the eIFU Regulation?
The European Commission is currently considering amendments to the existing eIFU regulation. Based on the new draft proposal (PLAN/2024/2826), here are the expected changes:
Easy IFU – Your eIFU platform
Test this platform that will manage your eIFU.
- All compliant with EU 2021/2226.
- And the first project is for free.
- And includes a Label creation module
so don’t miss it.
Summary and Next Steps
Let’s summarize
The transition to eIFUs marks a significant step toward modernizing medical device documentation. While it offers numerous advantages, strict regulatory compliance is necessary to ensure patient safety and data security.
If you’re a manufacturer, ensuring compliance with Regulation (EU) 2021/2226 and preparing for the upcoming legislative changes is crucial. Stay updated with the European Commission’s final approval of the new amendments, and make sure your eIFU system aligns with the latest safety, usability, and cybersecurity standards.
For further details, check the official EU Regulation (EU) 2021/2226 here and stay tuned for the final adoption of the new changes.
How can we help?
Easy Medical Device is offering you the opportunity to create your eIFU within its platform for free. This platform is called Easy IFU.
Check it here: https://easyifu.com
About the Author: Monir El Azzouzi
