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eIFU Solutions

Proven and compliance focused e-labeling for Medical Devices & IVDs.

Looking to launch your eIFU or migrate while minimizing risk and saving time / costs ?
With 10 plus years’ experience in Labeling, DDi is your partner.

Schedule Free Demo

For over 10 years, DDi has been empowering medical device and IVD manufacturers to stay compliant with global regulations and improve operational efficiency.

When it comes to eIFU, we have helped thousands of manufacturers minimize costs associated with paper-based Instructions for Use (IFU) by making them available online in a compliant and user-friendly format.

We are certified in ISO 13485, and our data security practices are backed by ISO/IEC 27001 certification – ensuring robust compliance and security.

Our eIFU solution has been trusted by numerous manufacturers for many years. Whether you have one product or thousands, we offer simple to scalable options to help you meet e-label compliance, business goals, and budgetary needs.

11-B-Braun 11-B-Braun
12-Brainlab 12-Brainlab
13-Johnson-&-Johnson 13-Johnson-&-Johnson
14-Philips-Healthcare 14-Philips-Healthcare
15-Sartorious 15-Sartorious
16-Oxford-Immunotec 16-Oxford-Immunotec
Guertbet Guertbet
21-Intuitive 21-Intuitive
Cordis Cordis
MI-Tech MI-Tech
DAS DAS

Why DDi

  • Certified in ISO 13485
  • Single solution provider for both Software and Print service management
  • Audited by multiple Notified Bodies till date
  • Regulatory, Labeling and IT subject experts to guide the transition process
  • Data in ISO 27001 certified data centers (USA/Germany) and GDPR compliant
  • Trusted by many Manufacturers for their eIFU for several years
DDi-eIFU-on-Macbook

eIFU Solution Features and Benefits

Out-of-box or Custom eIFU Portal

Visu is designed for speed and simplicity – get your eIFUs online compliantly without hassle.

  • Intuitive, off-the-shelf solution
  • Easy to implement
  • Highly configurable interface
  • Smart search functionality
  • Personal training on use of Visu eIFU
  • Expert regulatory support
  • Trusted by Notified Bodies

Regulatory Compliance

Compliance is core of Labeling. Constant checking of different country changes and informing manufacturers on changes.

  • EU MDR, FDA, Canada, Brazil, Australia compliance included
  • FDA 21 CFR Part 11 compliant
  • Analytics and reporting features
  • GDPR compliance
  • All audit-ready documents provided
  • Data centre certified in ISO 27001

Admin Access for You & Controlled Document Access to End Users

Manage your eIFUs with ease using Visu’s secure, compliant, and customizable admin platform

  • Role-based access control for manufacturers
  • Workflow based and edms inbuilt
  • All Reports along with Audit trail included in backend for self-service
  • For end users, control or manage what healthcare professions should see and what patients should get
  • Mange by country and language
  • Subscription & notification
  • Enterprise edition: PLM/EDMS integration, workflows, branding

Print & Shipping Services

Our 24×7 service desk ensures timely, compliant delivery of IFU hard copies.

  • ISO 20000-compliant in-house service desk
  • Manage print requests & delivery (or coordinate with your team)
  • 7-day turnaround per EU regulation
  • Audit trail print reports for compliance & traceability

Made with Visu eIFU Platform

Website / Portal (examples of What your end users see)

Try 2 sample sites made with Visu eIFU platform:  Sample 1      Sample 2

Visu eIFU Admin Access(from this you manage Data & Documents)

  • MDR (EU 2021/2226), FDA and other regulations Compliant
  • Role & Permission Driven
  • Multi-language, Multi-versions linked by Products and Document versions
  • Enterprise version option with workflows, connect to your PLM & EDMS, custom branding and other premium features
  • 21 CFR Part 11, GAMP compliant and validated
  • Security measures and Privacy Policy are in compliance with GDPR

Explore eIFU Insights

Why eIFU is Future of Device Labeling

| admin |
Medical device manufacturers are under increasing pressure to improve patient safety, meet evolving regulatory stand...
Read Blog

Global eIFU Regulations: A Region-by-Region Compliance Guide

| admin |
What Is eIFU? eIFU refers to electronic Instructions for Use - digital versions of the traditional paper manuals ...
Read Blog

What is eIFU? A Complete Guide to Electronic Instructions for Use

| admin |
In a healthcare environment driven by digitization and innovation, traditional paper-based labeling is quickly givin...
Read Blog

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.
Read more:

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.
Read more:

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

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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

Ready to Digitize Your IFUs?

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

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The First Step

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