Medical device manufacturers are required to provide clear, accurate, and up-to-date instructions for use (IFUs) to ensure patient safety and regulatory compliance. Traditionally these instructions have been provided in printed format, but as digital solutions become more practical and widely accepted, many manufacturers are transitioning to electronic instructions for use (eIFUs).

Adopting eIFUs can improve accessibility, reduce costs and is better for sustainability. However, it also introduces new compliance challenges and considerations. This guide explores eIFU regulations, benefits, challenges, and best practices for implementation, as well as how software can help manufacturers manage compliance efficiently.

What is an eIFU?

An electronic instruction for use (eIFU) is a digital version of the traditional printed IFU. Instead of being included in product packaging, eIFUs are made available through a secure website, QR code, or other digital formats.

The transition to eIFUs is being driven by regulatory updates, advancements in technology, and industry-wide efforts to reduce costs and environmental impact. Electronic IFUs enable real-time updates, ensuring that healthcare professionals, and consumers, always have access to the most accurate and up-to-date instructions.

Why transition to eIFU? 

While traditional paper IFUs have long been the standard, and are still required for some devices, advancements in technology and evolving regulatory changes have made digital alternatives more practical, sustainable and beneficial.

For manufacturers, healthcare professionals, and regulatory bodies alike, eIFUs offer several key advantages:
 

“With so much change afoot in the industry, from regulations and policies, it’s no surprise that more and more medical device manufacturers are moving towards digital labeling and packaging. Traditional IFUs no longer meet the requirements, nor the increasing demand the industry continues to see.

With the right technology at their fingertips, eIFUs now take just minutes to update. Key information, across multiple products and markets, can be at the fingertips of medical professionals and, crucially, consumers, in an instant.

Critical to the future of the industry, the introduction of eIFUs will help to improve efficiencies, reduce error rate, remove additional burden from already time-pressed healthcare professionals and drive sustainable practices, all while ensuring the safety of patients. EIFUs are a welcome solution to the fast-paced medical device industry.” - Stuart Powell, Chief Product Officer at Kallik

What regulations apply to eIFU?

Medical device manufacturers looking to implement electronic instructions for use (eIFUs) must comply with strict regulatory requirements to ensure accessibility, accuracy, and patient safety. 

EU Regulations: MDR & Implementing Regulation 2021/2226

The European Union has established Regulation (EU) 2021/2226, which defines the conditions under which medical devices may provide eIFUs instead of printed documentation. This regulation applies to specific categories of devices, particularly those intended for professional use.

Key Requirements for eIFUs in the EU:

• eIFUs must be made available via a secure, compliant website that is regularly updated.
• The manufacturer must conduct a risk assessment to ensure that providing an eIFU instead of a printed IFU does not pose safety concerns.
• Printed IFUs must still be available upon request, and users must be informed of how to obtain them.
• The eIFU must be accessible in all official EU languages required for the device’s intended market.
• The eIFU must be designed to remain accessible for the expected lifetime of the device, even if the device is discontinued.
• Adequate cybersecurity measures must be in place to prevent unauthorized modifications to the eIFU content.

U.S. Regulations: FDA Guidance on eIFUs

In the United States, the FDA has comparatively less specific guidance on the use of electronic IFUs. However, they do permit eIFUs for certain prescription medical devices used in professional healthcare settings. This is outlined in Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) which states:

“Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”

Key FDA eIFU compliance considerations:

• The eIFU must be accessible at the point of use and must not compromise device safety.
• The manufacturer must provide clear instructions on how users can access the eIFU.
• A printed version must be available upon request.
• The eIFU must be hosted securely to prevent tampering.
• Updates to the eIFU must be tracked and documented, ensuring that healthcare professionals always access the latest version.
• While the FDA has not yet mandated universal eIFU adoption, manufacturers considering digital IFUs should ensure they meet both FDA labeling regulations and Good Manufacturing Practices (GMPs).

How labeling management software can help

Managing electronic instructions for use (eIFUs) in compliance with regulatory requirements can be complex, especially for medical device manufacturers operating in multiple markets. Strict version control, multilingual requirements, real-time updates, and cybersecurity concerns make manual processes inefficient and prone to errors.

Labeling management software provides a structured, automated approach to eIFU compliance, streamlining workflows and reducing regulatory risks.

Kallik's end-to-end labeling and artwork management software helps medical device manufacturers to overcome challenges related to eIFU:

Automating compliance with regulatory standards:

• Comprehensive approval processes are required before publishing updates.
• Maintain audit-ready documentation for regulatory inspections.

Version control and change management:

• Automated version tracking, preventing outdated instructions from being accessed.
• Full audit trails, documenting changes, approvals, and user access.
• Role-based access control, ensuring only authorized users can edit or approve eIFU updates.

Centralized multilingual management:

• Ensure all language versions are consistent and compliant with local regulations.
• Updates can be efficiently applied across multiple languages without duplicating efforts.
• Translations can then be approved for accuracy, reducing the risk of misinterpretation.

Reducing manual work and human errors:

• Easily search for and replace specific symbols with automated ‘Where Used’ function
• Automate approval workflows, reducing delays in publishing updated IFUs.

Want to see how Kallik’s innovative software can benefit your labeling and artwork management process with the power of automation and AI? Get in touch by emailing enquiries@kallik.com or calling +44 (0) 1827 318100, or alternatively, book your one-to-one demo here.