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Paperless Compliance.
Unlimited Global Reach.

The Proven eIFU Labeling Solution for Medical Devices & IVDs

Transition seamlessly from traditional paper or manual or home grown websites to a fully compliant electronic ifu medical device framework. Visu eIFU helps MedTech manufacturers minimize compliance risk, cut operational printing costs, and maintain total alignment with ISO 13485, EU MDR, FDA, Canada, Brazil, Australia and other global regulatory requirements.

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Years Of Proven MedTech Regulatory, Labeling & Quality Expertise

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Trusted By Global Medical Device and IVD Manufacturers

27001

ISO Certified Data Security

13485

ISO Certified Company

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Audit Ready Documentation At All Times

Regulations

Fully Compliant With Major Countries

Trusted by Leading Medical Device Companies

Why Choose Visu eIFU?

As a specialized eIFU partner, DDi provides an end-to-end, highly adaptable eIFU software
platform designed to remove the friction from global regulatory compliance.

global-compliance

Comprehensive Global Compliance

Out-of-the-box readiness for eu mdr electronic ifu requirements (EU 2021/2226), FDA, Health Canada, ANVISA (Brazil), and TGA (Australia). Our regulatory intelligence team tracks global updates so your portals stay compliant automatically.

highly-configurable

Flexible & Highly Configurable

An intuitive, ready-to-deploy web portal with customizable branding, smart portfolio search, and language switching tailored directly to your product lines.

robust-security

Enterprise-Grade
Security

Hosted in ISO 27001-certified data centers across the US and Europe. Fully GDPR compliant with built-in document validation and instant audit trail generation.

print-services

Print & Shipping
Services

Full support for paper-on-demand regulations. Includes an integrated ISO 20000-compliant service desk guaranteeing a 7-day physical copy turnaround as mandated by EU standards.

analytics-audits

Actionable Reports & Audit Trails

: Complete visibility into user traffic, document access logs, role-based permissions, and time-stamped revision histories for complete self-service reporting.

user-centric

Patient vs. Professional Segmentation

Granular control over target audiences. Direct healthcare professionals to technical instructions while providing simplified, country-specific content for patients.

24x7 Service Desk for support 

Key Capabilities

Ready-to-Deploy or Tailored Portals

Visu eIFU is built for speed and administrative ease. Publish your digital instruction manuals without complex
IT overhead.

  • Off-the-shelf implementation with modular setup options
  • Configurable brand design and responsive mobile layouts
  • Intelligent multi-language search engine
  • Dedicated onboarding, user training, and ongoing regulatory consultation
  • Validated and trusted by Notified Bodies worldwide

Built-In Regulatory Control

Regulatory compliance is the foundation of modern labeling. Our specialized MDR eIFU software continuously reflects changing standards so you never miss a regulatory shift.

  • Automated compliance alignment for EU, US, LATAM, and APAC regions
  • FDA 21 CFR Part 11 electronic signature and audit trail support
  • Comprehensive GDPR compliance architecture
  • Turnkey audit documentation provided out of the box

Centralized Admin Operations & Controlled Access

Maintain full command over document lifecycle workflows while giving end users a seamless viewing experience.

  • Role-based access governance for internal regulatory and labeling teams
  • Built-in workflow approval engines and native EDMS capabilities
  • Audience-specific access settings (Healthcare Professionals vs. Patients)
  • Automated subscriber notifications for updated instructions
  • Enterprise tier options: Seamless integration with PLM, ERP, and EDMS platforms

Made with Visu eIFU Platform

See how leading MedTech brands present their e-labeling portals. (Click images to enlarge)

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Sample Site 1
Sample Site 2

Ready to Digitize Your IFUs?

Experience seamless e-labeling with Visu eIFU – ensuring compliance, global access, and user-friendly navigation.

Schedule eIFU Demo

Frequently Asked Questions (FAQs)

1. What is an electronic IFU for a medical device?
An electronic ifu medical device solution delivers product instructions digitally via a secure online platform rather than paper inserts. It ensures healthcare providers and patients always access the latest approved version while significantly lowering paper production and shipping costs.
2. How does eIFU software help with EU MDR compliance?
Under EU MDR regulations (such as Implementing Regulation EU 2021/2226), manufacturers using digital labeling must guarantee strict document control, revision history tracking, fast paper-copy request processing, and data security. Purpose-built eu mdr electronic ifu systems automate these requirements while maintaining audit-ready logs.
3. What are the main operational advantages of adopting eIFU software?
Deploying dedicated eIFU software reduces physical packaging mass, eliminates waste, enables instant global deployment of updated safety information, and provides precise tracking of localized document revisions.
4. How does Visu eIFU manage global regulatory variations?
Visu eIFU is pre-configured to handle distinct requirements across major markets, including FDA rules in the US, EU MDR/IVDR in Europe, ANVISA in Brazil, and TGA in Australia. The platform restricts or adapts content visibility depending on the visitor's geographic location.
5. Why should manufacturers use dedicated IFU MDR software instead of a standard website?
Standard websites lack mandatory regulatory safeguards. Specialized IFU MDR software provides strict version control, time-stamped audit trails, secure ISO-certified hosting, emergency downtime contingencies, and targeted user permissions required during regulatory inspections.
6. Is electronic labeling suitable for international distribution?
Yes. Electronic labeling platforms excel in multi-country strategies by serving localized, language-specific versions dynamically based on regional regulatory approvals.
7. How does Visu eIFU ensure data privacy and security?
The platform is hosted within ISO 27001-certified facilities, fully compliant with international privacy laws like GDPR, and features role-based access management alongside comprehensive system logging.
8. Can Visu eIFU integrate with our existing PLM or EDMS?
Yes. Visu eIFU offers robust API integrations for enterprise Document Management Systems (EDMS) and Product Lifecycle Management (PLM) tools, facilitating unified document distribution across your business.

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eIFU Regulations & Guidelines

Regulations and Guidelines

eIFU guidance for IVDs


eIFU regulation for MDs (under MDR)

eIFU regulation for MDs (under MDD)


EU regulation for IVDs

EU regulation for MDs


GDPR

MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices.
Read more:

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.
Read more:

Commission Regulation (EU) No 207/2012 of 9 March 2013 on electronic instructions for use of medical devices.
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Regulation (EU) 2017/746 of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
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Regulation (EU) 2017/745 of 5 April 2017 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Read more:

Regulation (EU) 2016/679 of 25 May 2018 on Regulation on the protection of natural persons regarding the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive).
Read more:

US Regulations (FDA)

FDA regulation for MDs & IVDs

FDA regulation for MDs & IVDs on labeling and advertisements

FDA regulation on use of electronic records & signatures

FDA regulation to authorize eIFU

Federal Food, Drug, and Cosmetic Act (FD&C Act) – Chapter V: Drugs and Devices – Part A Drugs and Devices and Part D Dissemination of Treatment Information.
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U.S. Code, Title 21, Chapter 9, subchapter V, Part A, §352 Misbranded drugs and devices.
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U.S. Code, Title 21, Chapter 11, Electronic records; electronic signatures.
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Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities.
Read more:

US Guidance Documents (FDA)

FDA regulation for MDs & IVDs

Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals

Guidance for Industry; March 2006
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March 2010.
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Notice 10-123767-875: Guidance for the labelling of Medical Devices, not including in vitro diagnostic devices.

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Normative Instruction – IN No. 4, of June 15th 2012.

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SFDA/MDS Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices (MDS – G41, of September 29, 2019)

Electronic Instructions for Use – eIFU: For professional users of medical devices (including IVDs) – v1.0 August 2018 (Therapeutic Goods Administration).

Read more

SDLC standard used for the development of the IFUcare website

IEC 62304:2006: Medical device software – Software life cycle processes

Read more

ISO 13485

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

Read more

ISO 14971

Medical Devices – Application of Risk Management to Medical Devices

Read more
The First Step

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