Electronic Instructions for Use (eIFUs) are digital versions of traditional printed instructions for use for medical devices. They offer numerous advantages, including improved accessibility and a reduction in paper consumption. This article explores the current situation in the European Union, global regulatory developments, and the requirements that medical device manufacturers are expected to meet in the future.
Electronic instructions for use have been a topic in the European Union since 2012. Regulation (EU) No. 207/2012 on electronic instructions for use for medical devices was replaced on 14 December 2021 by Implementing Regulation (EU) 2021/2226. On 25 June 2025, an additional amendment followed with Implementing Regulation (EU) 2025/1234. This new regulation establishes the requirements and conditions under which eIFUs may be used for medical devices marketed in the EU.
Current Conditions for Using eIFUs in the EU
The use of eIFUs is subject to specific requirements relating to the user, the product, the manufacturer, and the website:
- User: eIFUs are only permitted for products intended for professional users. Products for which use by laypersons can reasonably be expected must still be accompanied by a paper version. However, for software products, the use of eIFUs is permitted even for lay users.
- Manufacturer: Manufacturers must ensure that eIFUs are accessible at all times and that a printed version can be provided upon request within a short period of time.
- Website: The eIFU must be made available on a website managed by the manufacturer. In addition, the website must be user-friendly and provide the eIFU in the official language(s) of the respective Member State.
- Product: Previously, eIFUs could only be used for certain categories of products, such as implantable and active implantable medical devices, fixed installed medical devices, and their accessories. This restriction has been removed under Regulation (EU) 2025/1234.
Stricter requirements now apply to accessibility and security. Security standards have been increased to protect eIFUs against unauthorized access by third parties. Furthermore, manufacturers providing eIFUs are required to notify the competent authorities. This includes registering eIFU URLs in EUDAMED and linking them to the corresponding product data (UDI records).
eIFUs and Their Benefits
The introduction of eIFUs provides numerous benefits for both users and manufacturers. According to BVMed, eIFUs can significantly reduce paper consumption and enable smaller and lighter packaging without compromising safety. In addition, providing paper-based IFUs in all required national languages is currently a major logistical challenge. Keeping printed instructions up to date and including the latest version with every device is equally demanding.
With eIFUs, manufacturers not only reduce costs but can also enhance product safety. Digital delivery ensures that instructions for use are always available in the latest version and in all required languages. For example, in a hospital setting, two physicians using identical devices can access the instructions simultaneously in their respective native languages without having to search for the appropriate paper documentation.
Additional benefits include improved usability, enhanced accessibility, and the ability to integrate multimedia content such as videos and animations.
- Environmental Sustainability: eIFUs reduce paper usage and packaging size, resulting in a lower environmental impact.
- User Friendliness: eIFUs are easily accessible and can include multimedia content such as videos and animations, improving usability and understanding.
- Cost Savings: Manufacturers can reduce costs by eliminating the logistical burden of producing and distributing printed instructions in multiple languages.
- Accessibility: Users with visual impairments can enlarge digital IFUs as needed or use text-to-speech functionality.
The EU Draft Regulation and Its Implications for the Future of eIFUs
The EU is not the only region embracing digital product information. Around the world, many countries have recognized the benefits of eIFUs and permit their use under various conditions. These include the FDA (United States), Health Canada (Canada), TGA (Australia), ANVISA (Brazil), SFDA (Saudi Arabia), PMDA (Turkey), and the Ministry of Health (India).
The continued expansion of eIFUs within the EU therefore also contributes to the global competitiveness of European medical device manufacturers.
Within the EU, the regulatory framework and requirements continue to evolve. The objective of Implementing Regulation (EU) 2025/1234 was to facilitate and expand the use of eIFUs. Although the regulation represents an important step in the right direction, the range of eligible medical devices remains limited. It is therefore hoped that the availability of digital instructions for use will continue to expand in the future.
These recent changes are intended to further promote the adoption of eIFUs and accelerate digitalization in healthcare. They provide both manufacturers and users with greater flexibility and security. At the same time, the requirements placed on eIFU systems are increasing. For most medical technology manufacturers, the key question is how to provide eIFUs in a legally compliant manner.
Our eIFU solution can help you meet these requirements efficiently and compliantly.