Understanding eIFU for Medical Devices under EU MDR and IVDR

SAY GOODBYE TO PAPER? UNDERSTANDING EIFU IN THE EU THE EASY WAY
In the EU, every medical device must include clear Instructions for Use (IFU) to help users operate it safely. Traditionally, this information is provided on paper, but many manufacturers now prefer offering it digitally as an electronic IFU (eIFU) for example, through a website or app. Under the MDR (EU 2017/745), eIFUs are allowed when certain conditions are met, and these conditions are defined in Implementing Regulation (EU) 2021/2226 and the updated Regulation (EU) 2025/1234. These rules make sure that digital instructions remain accessible, safe, and reliable. eIFUs reduce printing and shipping costs and allow faster updates whenever information changes. They can also be more user-friendly by including videos, illustrations, and multiple languages. However, companies must ensure users can still easily access instructions especially in emergencies or in places with poor internet. Manufacturers also need a strong digital system with proper version control and backup paper copies when required. The IVDR (EU 2017/746) does not follow the same eIFU regulation as MDR. Instead, it has its own rule: eIFUs are allowed only for professional-use IVDs, and not for devices used near the patient (e.g., point-of-care testing). For these, paper IFUs remain mandatory. This means IVD manufacturers must carefully check whether their device type is eligible before switching to digital instructions. eIFU can be a great tool for modernising device information saving costs, improving usability, and making updates quicker. But manufacturers must follow the specific MDR rules (or IVDR requirements for IVDs), ensure strong risk controls, and always provide accessible, reliable instructions for users.

SAY GOODBYE TO PAPER? UNDERSTANDING EIFU IN THE EU THE EASY WAY

In the EU, every medical device must include clear Instructions for Use (IFU) to help users operate it safely. Traditionally, this information is provided on paper, but many manufacturers now prefer offering it digitally as an electronic IFU (eIFU) for example, through a website or app. Under the MDR (EU 2017/745), eIFUs are allowed when certain conditions are met, and these conditions are defined in Implementing Regulation (EU) 2021/2226 and the updated Regulation (EU) 2025/1234. These rules make sure that digital instructions remain accessible, safe, and reliable.

eIFUs reduce printing and shipping costs and allow faster updates whenever information changes. They can also be more user-friendly by including videos, illustrations, and multiple languages. However, companies must ensure users can still easily access instructions especially in emergencies or in places with poor internet. Manufacturers also need a strong digital system with proper version control and backup paper copies when required.

The IVDR (EU 2017/746) does not follow the same eIFU regulation as MDR. Instead, it has its own rule: eIFUs are allowed only for professional-use IVDs, and not for devices used near the patient (e.g., point-of-care testing). For these, paper IFUs remain mandatory. This means IVD manufacturers must carefully check whether their device type is eligible before switching to digital instructions.

eIFU can be a great tool for modernising device information saving costs, improving usability, and making updates quicker. But manufacturers must follow the specific MDR rules (or IVDR requirements for IVDs), ensure strong risk controls, and always provide accessible, reliable instructions for users.

INTRODUCTION

The regulatory landscape for medical devices in the European Union has long emphasized the importance of Instructions for Use (IFU) to ensure the safe and effective operation of devices. With the advent of digital technologies, manufacturers are increasingly exploring electronic Instructions for Use (eIFU). This blog explains what eIFU means in the context of the MDR (Regulation (EU) 2017/745), and clarifies that it is not directly regulated by the IVDR (Regulation (EU) 2017/746). It also discusses how the regulatory framework supports or restricts eIFU, as well as the advantages and challenges manufacturers face.

WHAT IS AN eIFU?

An IFU (instructions for use) is the set of information supplied by the manufacturer with the device that instructs users on safe and effective use. Under MDR, Article 23.1 states:

MDR Article 23.1: “Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate.”

An electronic IFU (eIFU) refers to providing this information in a digital format (for example via a website, embedded in software, or via an app) instead of or in addition to a paper IFU.The EU has explicitly addressed eIFU under the Commission Implementing Regulation (EU) 2021/2226 and (EU) 2025/1234, which lays down conditions for the application of MDR for eIFU.

Additionally, Implementing Regulation (EU) 2025/1234 now clearly includes devices that do not have a medical purpose, as defined in Annex XVI of the MDR.

IMPACT AND ADVANTAGES FOR MANUFACTURERS

Advantages

Cost savings & environmental benefit: Reduced printing, warehousing, and logistics.
Faster updates: Enables timely changes and version control.
Enhanced usability: Use of videos, interactive guides, and better formatting.
Digital tracking: Provides analytics for user access and post-market surveillance.
Global reach: Easier to localise and translate for multiple EU countries.

Impact on Regulatory Strategy

eIFU decisions must be incorporated into early regulatory planning.
The technical documentation must include risk analysis and platform validation.
Clear labelling and fallback paper IFU availability are essential.

DISADVANTAGES / CHALLENGES FOR MANUFACTURERS

Access issues: Risk of non-accessibility during emergencies or poor connectivity.
User resistance: Some users may prefer paper-based formats.
Version control complexity: Maintaining accuracy and security of digital files.
Uncertainty for IVDs: No clear implementing regulation under IVDR.
Language management: Ensuring all necessary languages are available.
Infrastructure demands: Requires a robust and compliant digital platform.

SPECIFIC CONSIDERATIONS FOR IVD MANUFACTURERS UNDER IVDR

Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic medical devices (IVDs). Instead, the relevant legal framework for IFUs is found directly within the IVDR.

Annex I, Chapter III, Section 20.1(f) of the IVDR provides the regulation for non-paper format IFUs:

It allows non-paper formats (including eIFUs) for devices intended for professional use only, except for devices intended for near-patient testing.
For devices intended for near-patient testing, the provision for eIFU does not apply, and physical paper instructions are mandatory.

CONCLUSION

The shift to electronic instructions for use represents a strategic opportunity for manufacturers under MDR. When properly implemented, eIFU can reduce costs, improve user experience, and enable real-time updates. Manufacturers should approach eIFU not just as a regulatory compliance matter but as a tool to modernise device deployment, support end-users effectively, and enhance operational agility. With careful planning, thorough risk analysis, and proactive regulatory engagement, eIFU can be a key enabler in a digital-first medical device environment.

HOW MORULAA CAN HELP

At Morulaa HealthTech, we guide medical device and IVD manufacturers through every step of MDR and IVDR compliance from documentation and registration to eIFU strategy and implementation. Our team ensures your eIFU approach meets EU requirements, supports notified body submissions, and aligns with your technical documentation and risk management processes.