Imagine this: you’ve designed a breakthrough medical device that could improve patient outcomes and transform clinical care. However, in the hands of a nurse in Germany, a distributor in India or a field technician in Brazil — what if the Instructions for Use (IFU) are missing, confusing, outdated or not even in the right language? That’s not just an inconvenience, it’s a risk to safety, compliance and the customer experience.

In a world where precision healthcare meets digital innovation, medical device manufacturers are rethinking every touchpoint of the product lifecycle and the humble IFU is no exception. Welcome to the era of electronic Instructions for Use (e-IFU). A smarter, faster and more sustainable way to deliver essential product information.

The turning point: Why traditional IFUs no longer work

Historically, IFUs were printed, folded and tucked into device packaging. A process so entrenched in manufacturing workflows that it became invisible. However, behind the scenes it carried significant weight: complex multilingual printing, rising logistics costs, cumbersome label management and limited flexibility for updates. As global regulations tighten and user expectations evolve, the cracks in this system have widened.

Traditional paper IFUs are no longer scalable, compliant or environmentally sound. They’re a relic of a paper-first world that’s no longer fit for today’s digital-first healthcare ecosystem. More importantly, regulations like the EU Medical Device Regulation (EU MDR) are now paving the way for paperless compliance, allowing manufacturers to publish IFUs electronically, with full traceability, control and accessibility. Now, that’s exactly where the story of e-IFU begins.

Redefining the IFU: From static paper to smart digital

At its core, the IFU exists to ensure safe and informed device usage. Yet, the way it’s delivered makes all the difference.

• Traditional IFUs are static, physical documents, printed in multiple languages and sealed within the packaging. Once printed, they can’t be updated
• e-IFUs, on the other hand, are dynamic, accessible and adaptable. Hosted online or embedded within devices via QR codes or software, they can include videos, interactive visuals, voice guides and real-time updates in any language

This isn't just a change in format; it’s a shift in paradigm. A shift toward connected care, intelligent content and real-time support.

The regulatory green light: Enabling paperless transformation

What once seemed like a compliance minefield is now a well-mapped opportunity. A host of global regulations are encouraging this transition:

• EU MDR 2017/745 and EU Regulation 2021/2226
• 2025 Amendment 2025/1234, enabling broader digital adoption
• FDA Section 352(f) under the Federal Food, Drug and Cosmetic Act
• ISO 20417:2021 for device manufacturer information standards

Together, these frameworks provide a strong foundation for e-IFU deployment, ensuring compliance, patient safety and digital readiness.

A four phased approach to implementing an e-IFU strategy

Successfully transitioning to e-IFU requires a structured, scalable and compliant strategy. At HCLTech, we guide clients through a four-phase roadmap designed to ensure regulatory alignment, operational readiness and long-term success.

1. Assessment phase – Understanding the landscape: The first phase centers on evaluating regulatory feasibility, geographic requirements and business risks associated with moving from paper to digital.

• Global regulatory assessment: Analyze regulatory guidelines across markets to identify where e-IFUs are permitted and where physical IFUs remain mandatory
• Country-level compliance mapping: Develop a matrix of regions requiring printed IFUs and assess the corresponding product volumes impacted
• Risk assessment and mitigation planning: Identify and document potential risks, such as user accessibility challenges, legal and regulatory exposure, cybersecurity vulnerabilities and technical constraints, along with appropriate mitigation strategies

2. Planning phase – Designing the framework

This phase focuses on establishing the operational, labeling and compliance infrastructure required to support a dual e-IFU and hard copy strategy.

• On-demand print process design: Define a compliant, scalable process for fulfilling hard copy IFU requests, including handling timelines, documentation and logistics
• Label review and optimization: Assess existing product labels to ensure inclusion of required e-IFU references (QR codes, URLs, customer service contacts) and update them as needed
• QR code integration and mapping: Strategically assign QR codes to the correct IFU versions and languages to enable real-time traceability and regulatory version control

3. Execution phase – Operationalizing the solution

This is the deployment phase, where systems are activated and teams are equipped to manage the transition at scale.

• Website publication: Upload e-IFUs to a secure, compliant and globally accessible platform optimized for multi-device use and user convenience
• Stakeholder training: Conduct comprehensive training sessions for internal teams (regulatory affairs, quality, manufacturing, customer service, supply chain) and external partners (distributors, healthcare providers) to ensure smooth adoption
• Production floor integration: Implement updated labeling and packaging processes on the shop floor, including QR code generation, label verification, bill of materials updates and digital documentation workflows

4. Sustainment phase – Driving continuous compliance and improvement

The final phase ensures long-term scalability, regulatory adherence and operational resilience.

• Regulatory monitoring: Continuously track global updates to regulatory frameworks and adjust the e-IFU strategy accordingly
• Audit and feedback mechanisms: Establish periodic audits and feedback loops to refine content, improve user experience and ensure sustained compliance
• Print infrastructure maintenance: Maintain robust systems for providing printed IFUs on demand to meet market-specific or customer-driven requirements
• Content and platform updates: Regularly review and update e-IFU content, interfaces and supported languages to reflect product enhancements and evolving user needs

The real payoff: Leading the future of healthcare communication

The move to e-IFU is more than a regulatory checkbox — it’s a business enabler, by delivering significant operational, regulatory and environmental advantages, while enhancing user experience and accelerating business outcomes.

• Enhanced user experience: Intuitive, multilingual and media-rich instructions available on demand via digital platforms
• Accelerated time to market: Enables faster product launches and agile lifecycle management through real-time content updates
• Material and waste reduction: Eliminates printed materials, reducing paper consumption and packaging complexity
• Lower operational costs: Reduces expenses related to printing, storage and physical distribution
• Improved process efficiency: Streamlines content updates, version control and distribution across global markets
• Regulatory readiness: Supports compliance through digital traceability, audit trails and up-to-date documentation
• Sustainability alignment: Advances ESG goals by minimizing environmental impact and resource usage
• Reduced carbon footprint: Lowers emissions from printing, shipping and waste disposal activities
• Instant global access: Provides users with the latest instructions anytime via QR codes, websites or mobile apps.

This is how e-IFUs are rewriting the rules of medical device documentation, by connecting information to intention and compliance to customer value.