Get Help with eIFU
Whether you’re just getting started or managing enterprise deployment, eIFU support gives you self-service guidance and responsive help from our expert team.
Support Options: • Help Center – Browse step-by-step articles, FAQs, and publishing guides • Submit a Request – Fill out our simple support request form • Email Us – Write directly to support@eifu.com for platform assistance
Frequently Asked Questions
Q:What is eIFU?
A:eIFU stands for electronic Instructions for Use. It refers to digital versions of product instructions that replace traditional paper manuals, especially in regulated industries like medical devices.
Q:What is an ePI?
A:An ePI (Electronic Product Information) is a digitally accessible version of regulated product information, commonly used in the pharmaceutical industry. It includes details such as dosage, contraindications, warnings, and patient guidance. eIFU.com supports full lifecycle management of ePIs, enabling companies to publish compliant, multilingual ePIs aligned with EMA, FDA, and ICH standards—accessible via QR code, barcode, or online search.
Q:What is a PIL?
A:A PIL (Patient Information Leaflet) is a document provided with medication that explains how to use it safely. It is required in many regions (e.g., EU) and must be clear, accurate, and accessible. eIFU.com makes it easy to manage PILs digitally—host them securely, translate for regional markets, and ensure version control to meet global health authority requirements.
Q:Is eIFU.com only for medical devices?
A:No. While eIFU.com is widely used in the medical device industry, it is built to support a much broader range of use cases. Organizations across pharmaceuticals, aerospace, food & beverage, insurance, and government sectors use the platform to manage and publish structured, regulated content securely and efficiently.
Q:What’s the difference between an IFU and an eIFU?
A:An IFU (Instructions for Use) is the printed version of product instructions typically included with physical packaging. An eIFU is the digital equivalent, accessible online or via QR/UDI scan. eIFU.com manages both types of regulated workflows and helps companies transition from paper to digital safely and compliantly.
Q:How do eIFUs help my organization?
A:eIFUs eliminate the burden of managing paper-based documentation, reduce corporate carbon footprint, and enable organizations to meet ever-changing regulatory standards that require electronic versions of product documentation.
Q:Which browsers and devices are supported?
A:eIFU.com supports most modern browsers, including Google Chrome and Microsoft Edge. It works across desktops, tablets, and smartphones, including iOS and Android.
Q:Can I use eIFU.com on tablets or smartphones?
A:Yes. The platform is fully optimized for mobile access, including touch-based navigation and responsive layout.
Q:How do I search for an artifact like a product or document?
A:You can locate documents on eIFU.com using multiple intuitive methods: Search Bar: Enter a product code, label part number, document title, GTIN, or keyword. The search returns all matching documents, including current and archived versions. QR Code or Barcode Scan: If enabled, scanning a printed QR code or barcode from the product packaging will take you directly to the specific document. Hierarchical Navigation: You can also browse through a graphical enterprise and product hierarchy, drilling down from business unit to product family and individual product to view associated documents.
Q:What does the tutorial cover?
A:On your first visit, a tutorial guides you through: • Home navigation • Search functionality • Header/footer menus • Content browsing • Personal settings
Q:What is eIFU.com?
A:eIFU.com is a secure, enterprise-grade platform for the management, publication, and global distribution of structured regulatory content—not just electronic Instructions for Use (eIFUs), but a wide spectrum of controlled documents across multiple industries. Designed for scalability and compliance, eIFU.com enables organizations to host and maintain multilingual, version-controlled documents such as: Patient Information Leaflets (PILs) Electronic Product Information (ePIs) Labels and Labeling Content Package Inserts (PIs) Regulatory Reports and Certificates MSDS/SDS Sheets Application Forms and Notices
Q:Which industries and document types does eIFU.com support?
A:eIFU.com serves a wide range of regulated and document-intensive industries, offering structured solutions tailored to each sector’s compliance and operational needs: Industry - Common Document Types Managed in eIFU.com, Medical Devices - IFUs, eIFUs, labels, sterilization certificates, clinical safety documentation, Pharmaceuticals - ePIs, PILs, SmPCs, regulatory labeling content, Automotive & Aerospace - Technical manuals, assembly instructions, compliance forms, safety certifications, Food & Beverage - Ingredient declarations, packaging specs, allergen statements, Insurance & Financial - Application forms, policy docs, disclaimers, compliance notices, Higher Education - Admissions materials, forms, compliance documents, Government & Immigration - Application forms, guidance documents, eligibility checklists, translated versions
Q:Can I print or save a document?
A:Yes. Use the toolbar in the eIFU viewer to print or download documents in PDF format.
Q:Can I email a document?
A:Yes. Select the email icon and enter the recipient’s address. Ensure your browser email settings are correctly configured.
Q:Where are my preferences stored?
A:Site preferences (e.g., language, history length) are saved in your browser cookies, not on our servers.
Q:Is any of my personal data stored or shared?
A:No personal data is stored or shared. The system retains no identifying user information.
Q:Is the site GDPR/CCPA compliant?
A:Yes. eIFU.com adheres to GDPR, CCPA, and international privacy laws, offering secure access with full data protection compliance.
Q:Do I need to install anything on my computer?
A:No! Our eIFU solution is deployed in a SaaS environment and accessed via a web-based application available on all common devices.
Q:How do I publish or update an IFU?
A:Use the eIFU Publisher Portal or API integration to upload PDFs and associated metadata.
Q:What file types are supported?
A:PDF, XML, HTML, audio, MP4 video, GLB/FBX 3D models, and image formats like PNG and SVG.
Q:Can I upload it in bulk?
A:Yes. Use Excel + PDF bundles or API endpoints to automate bulk uploads.
Q:Does eIFU.com support multiple languages?
A:Yes. You can publish IFUs with region- and language-specific filtering and assign content to locales.
Q:Is there a fallback to paper IFUs?
A:Yes. Per FDA and EU MDR, a printed version is available on request and delivered within regulatory timelines.
Q:How are versions managed?
A:Every IFU upload is versioned, stored with metadata, and archived for full traceability and historical access.
Q:What APIs are available for integration?
A:eIFU.com supports REST APIs for: • IFU uploads & metadata sync • Version updates • Retrieval of audit logs
Q:How are deployments architected? What options are available?
A:eIFU.com supports a range of deployment options based on organizational needs: SaaS (Cloud Hosted): Fastest to deploy. Managed by enLabel with global availability, uptime monitoring, and scalability. Private Cloud: Hosted in the client’s preferred cloud (e.g., Azure, AWS, GCP) under IT governance policies. On-Premises: Installed in the client’s internal environment for maximum data control and regulatory isolation. Hybrid: Combination of on-premises and cloud components, typically used for regional performance or segmented compliance requirements. Each deployment includes high availability, data backup, and support for multi-region access when applicable.
Q:How does PLM/ERP integration work?
A:You can: 1. Upload Excel/PDF bundles from PLM 2. Use the API for dynamic publishing from systems like SAP or Oracle
Q:Is the platform validated for regulatory use?
A:Yes. The platform is developed using a validated software lifecycle (IEC 62304) and is compliant with 21 CFR Part 11 and EU MDR.
Q:Is audit tracking available?
A:Yes. All publishing actions, updates, and downloads are tracked with full audit logs.
Q:Is eIFU.com compliant with FDA and EU MDR?
A:Yes. It adheres to: • EU MDR Regulation 2021/2226 • FDA Electronic Labeling Guidance • ISO 20417:2021 standards
Q:How long are IFUs retained?
A:As required: • 10 years after the last market entry for dated devices • 15 years for undated/implantable devices
Q:Are printed IFUs required?
A:Yes, on-demand printing is provided free of charge within 7 calendar days to comply with FDA and EU MDR.
Q:Are users notified when IFUs change?
A:Yes. The system can notify subscribers via email or dashboard alerts when documents are updated or corrected.
Q:What is a subscriber user?
A:A subscriber user is anyone who accesses documents published to eIFU.com by an organization. Subscribers typically include healthcare professionals, customers, regulatory authorities, or internal teams who need to view, print, or download product information. Subscribers do not have the ability to upload or manage documents.
Q:What is a registered subscriber user?
A:A registered subscriber is someone who creates a free account on eIFU.com. Registration unlocks additional features, such as access to My Collections, where users can save, organize, and revisit frequently used documents. Registered users can: - Search and access public and restricted content (depending on publisher rules) - Create and manage personalized folders in My Collections - Bookmark documents for future reference - Subscribe to document update notifications Basic registration is free, and users may upgrade to paid plans if they need additional document storage or enhanced functionality.
Q:Are users required to create an account?
A:Subscriber users do not have to create an account to access digital content on eIFU.com. By creating an account, registered subscriber users can gain additional features and functionalities, such as notifications for document updates, saved and favorited documents, and remembered preferences.
Q:What are My Collections?
A:My Collections is a personalized workspace within eIFU.com where registered users can save and organize documents, they frequently access. It functions like a private document library, allowing users to bookmark, categorize, and retrieve materials quickly. It is especially useful for patients, healthcare professionals, and regulatory teams who need recurring access to the same set of IFUs, ePIs, PILs, or other documents.
Q:How do I use My Collections?
A:To use My Collections, simply register for a free account on eIFU.com. Once logged in, you can: - Click the “Add to My Collections” icon next to any document - Organize saved documents into named folders - Access your saved documents from any device - Upgrade to a paid plan if you need additional storage space or advanced features My Collections helps streamline document access and ensures your frequently used content is always at your fingertips.
Q:How do I change language preferences?
A:Navigate to Site Preferences → Set My Language → Save.
Q:Can I view older versions of documents?
A:Yes. Use the Version dropdown in the viewer to select previous revisions.
Q:Can I mark favorites?
A:Yes. Use the "star" icon. Access your saved list from the top-right menu. NOTE: The favorite icon is a heart, rather than a star on the current eIFU.com deployment
Q:What accessibility features are supported?
A:• WCAG 2.1 compliance • Screen reader support • Font resizing • High contrast UI
Q:Can I track what I've viewed, saved, or printed?
A:Yes. Use the top-right activity menu to review your document interactions.
Q:Does it cost to search for documents?
A:No. Searching for documents on eIFU.com is free of charge for all users, including unregistered visitors, unless a publisher has restricted access to specific content.
Q:Does it cost to become a subscriber?
A:No. Becoming a subscriber and accessing documents on eIFU.com is free for end users. However, some content may require registration or be limited to specific authorized users, depending on the publisher’s configuration.
Q:How do I become a publisher?
A:To become a publisher on eIFU.com, your organization must have an active publisher license. Once licensed, your internal admin or the enLabel support team can create publisher user accounts. Publishers have access to upload, manage, and update content, define product hierarchies, and configure access permissions. If you're interested in becoming a publisher, contact us at sales@enlabel.com or sales@eifu.com to learn more.
Q:What licensing options are available?
A:Annual plans for publishers vary by company size (Small, Medium, Large) and document volume. Contact Sales for pricing.
Q:Is there a free trial for Publishers?
A:Yes. A 60-day free trial is available for new publisher accounts.
Q:How do I get help?
A:Visit our Support Page, email support@eifu.com, or submit a request via the contact form.
Q:How fast is support response?
A:We aim to respond within 1 business day.
Q:Can I speak to a human?
A:Yes. Phone support is available for enterprise clients during business hours.
Q:Can enLabel support my organization outside North America?
A:Yes. EnLabel’s eIFU solution can accommodate multinational organizations with language requirements, support hours, and required electronic formats. Our multilingual documents support automated and table-driven user interface translations.
Q:Do I need enLabel to publish documents or can a publisher manage documents on their own?
A:Publisher users can manage their organizational hierarchy and the publishing of documents entirely without enLabel, as eIFU.com is a self-service platform. EnLabel offers initial training and continued product support for publisher users to ensure the platform is being leveraged correctly.