eIFU

Why eIFU is Future of Device Labeling

Wed, 25 Jun 2025 06:06:13 +0000

Medical device manufacturers are under increasing pressure to improve patient safety, meet evolving regulatory standards, and streamline their documentation processes. Enter the electronic IFU (Instructions for Use) – a game-changer in the industry. With regulations such as the EU MDR enforcing stricter labeling and documentation practices, it’s become clear that traditional paper-based instructions just can’t keep up.

Electronic IFUs are digital versions of the paper instructions traditionally included with medical devices. They provide instant access, real-time updates, and regulatory compliance in a streamlined, eco-friendly format. If you’re in the medical device business, transitioning to eIFU isn’t just a good idea – it’s the future.

Let’s explore what makes eIFUs the future of medical device labeling and how platforms like DDi’s Visu eIFU are leading this digital transformation.

An eIFU, or electronic Instructions for Use, is a digital document that provides necessary information on how to safely use a medical device. These are hosted online, allowing users to view or download them from a designated website or platform. Unlike traditional printed manuals, eIFUs can be updated quickly and are accessible 24/7 from anywhere in the world.

The key difference is accessibility and flexibility. Think about the convenience of a user scanning a QR code on a device package and instantly accessing the latest, approved version of the instructions – no bulky paper, no outdated information, and no confusion.

Traditional vs. Electronic IFU

Let’s face it – printed IFUs are outdated. They’re costly, difficult to manage across multiple markets, and susceptible to human error. Every update means reprinting, repackaging, and redistributing, not to mention the risk of shipping outdated or non-compliant versions.

In contrast, eIFUs reduce errors, cut costs, and enhance efficiency. You can instantly update a document and ensure all users have access to the most current version. Plus, electronic IFUs are eco-friendly – say goodbye to reams of paper that often go unread.

Benefits of Implementing Electronic IFU for Medical Devices

Increased Accessibility and Convenience

Think about a busy surgeon needing instructions on a new surgical tool. Instead of rifling through paperwork, they scan a code and instantly get the information – formatted for mobile or desktop use, and always current. That’s the power of eIFU.

Accessibility is one of the most valuable benefits. Users can get what they need when they need it, in their preferred language and format. For international companies, this means quicker distribution, better support, and happier end-users.

Real-Time Updates and Version Control

Updating a printed IFU involves reprinting, redistributing, and re-certifying in some regions. With eIFU, it’s just a few clicks. Real-time updates allow manufacturers to quickly fix errors, make improvements, and comply with new regulations without any delay.

Plus, with automated version control, there’s no confusion about which document is current. That level of precision is vital for compliance and end-user safety.

Environmental and Cost Benefits

Switching to eIFU also brings tangible cost savings and a reduced environmental footprint. No printing, shipping, or storage means lower operational costs. Plus, it’s a sustainable move, aligning with corporate green initiatives and global environmental standards.

Going digital is no longer just a “nice to have” – it’s expected by consumers and regulators alike. Companies that make the shift now are positioning themselves as forward-thinking leaders in the med-tech space.

Key Features of Modern IFU Software

Integration with Regulatory Workflows

Modern IFU software is designed to plug directly into a company’s existing quality management and regulatory systems. This integration ensures that every step – from document creation to approval and publishing – is traceable, automated, and compliant with regulations.

No more manually moving files between departments or relying on email threads for approvals. A good eIFU system will manage document workflows, assign tasks to the right teams, and keep a clear digital trail for audits. It becomes the nerve center for your labeling process.

When your labeling process is tied into regulatory workflows, every change, approval, and update is documented. That makes audits smoother, reduces the chance of non-compliance, and saves countless hours of admin work.

Multilingual Support and Global Accessibility

Medical devices are sold worldwide, which means IFUs must be translated into numerous languages. One of the standout features of modern eIFU platforms is built-in multilingual support. You upload a master version, translate it within the platform, and the system ensures users see the version relevant to their region.

Plus, global accessibility means that healthcare professionals in any time zone can access critical information instantly. Whether it’s a hospital in Berlin or a clinic in São Paulo, users have equal access to accurate instructions.

This capability ensures compliance with local regulations and makes global distribution much more manageable.

Challenges and Considerations in Transitioning to eIFU

Technical and IT Infrastructure

Shifting to eIFU isn’t just a software purchase – it’s a transformation. Companies need a robust IT infrastructure to host, secure, and maintain digital IFUs. This includes choosing between cloud-based or on-premises solutions, ensuring data protection measures are in place, and integrating with existing ERP or QMS systems.

For smaller companies, this shift can feel overwhelming. That’s why choosing a scalable eIFU platform is key – it should grow with your business and integrate smoothly without a complete overhaul of existing systems.

In addition, companies must ensure internet connectivity and uptime for global users. Any downtime could result in delays in accessing critical instructions – something no healthcare provider can afford.

User Adoption and Training

Even the best technology will fail if users don’t adopt it. Transitioning to eIFU requires training both internal staff and external users. Regulatory, R&D, marketing, and support teams all need to understand how the system works and how to manage it effectively.

End users – surgeons, technicians, nurses – must also feel comfortable accessing IFUs digitally. Including video tutorials, QR codes on packaging, and intuitive interfaces helps improve adoption rates.

Training and change management should be treated as a project in itself, with goals, timelines, and metrics to ensure everyone is on board.

Future Trends in Medical Device Labeling

Artificial Intelligence and Smart IFUs

The future of medical device labeling is more intelligent and intuitive. With Artificial Intelligence (AI) integration, IFUs can evolve from static documents to interactive tools that adapt based on the user’s profile, device type, or usage environment.

Imagine a cardiologist accessing an eIFU that dynamically highlights the most relevant sections based on their device model, prior search history, or patient profile. That’s where we’re headed.

AI can also help in compliance management by monitoring changes in regulations and flagging outdated IFUs for updates. This predictive compliance feature can save companies time and prevent costly penalties.

Furthermore, AI can enhance user feedback mechanisms – analyzing user behavior, common questions, or errors – and prompting manufacturers to improve clarity and safety.

Blockchain and Secure Documentation

Blockchain is making waves in healthcare, and its application in medical device labeling is starting to show potential. By using blockchain, manufacturers can create a tamper-proof record of every IFU version ever published.

This decentralized approach not only enhances security but also ensures authenticity. Regulators and auditors can trace every document to its source, verify that it hasn’t been altered, and confirm user access logs with cryptographic proof.

This level of transparency and security will soon become the gold standard in global regulatory compliance – especially as data integrity becomes a top concern for global authorities.

Predictive Compliance Monitoring

Predictive compliance tools will revolutionize how manufacturers manage risk. Instead of reacting to non-compliance or complaints, predictive systems will use data from past updates, regulatory trends, and market behavior to anticipate when an IFU might become non-compliant.

Combined with machine learning, these tools will analyze patterns and suggest updates before a regulator even spots an issue. It’s like having a regulatory consultant working 24/7 behind the scenes – scanning databases, comparing document versions, and flagging risks proactively.

This predictive power will transform compliance from a reactive obligation to a proactive advantage.

Final Thoughts: Embracing the Digital Shift in Medical Labeling

The transition from printed documentation to electronic IFU medical devices is not just a technological shift – it’s a strategic move toward compliance, efficiency, and global competitiveness.

Whether you’re navigating the complexities of country specific electronic IFU regulations or looking to streamline your document control systems, embracing digital solutions is no longer optional. It’s necessary.

Platforms like Visu eIFU simplify this journey. They provide the tools, support, and innovation needed to move confidently into the future. With benefits ranging from real-time updates to global accessibility, the ROI of going digital is crystal clear.

Don’t wait until a regulator mandates the change or a competitor beats you to it. Now is the time to invest in IFU software, upgrade your labeling strategy, and become a leader in the next era of medical technology.

Tags: Digital IFU, eIFU, Electronic IFU Medical Device, electronic labeling, EU MDR Electronic IFU, IFU MDR Software, MDR compliance, Medical device Labeling, Medical Device Software, Regulatory Compliance

How eIFU Enhances Compliance and Efficiency in Medical Device Labeling

Fri, 21 Mar 2025 09:20:48 +0000

In the highly regulated medical device industry, compliance with labeling requirements is crucial to ensure patient safety and regulatory adherence. Traditional paper-based Instructions for Use (IFU) have long been the standard, but they come with challenges such as high printing costs, difficulty in updating information, and accessibility issues. To address these concerns, electronic Instructions for Use (eIFU) have emerged as a game-changing solution that enhances both compliance and efficiency in medical device labeling.

What is an Electronic Instructions for Use (eIFU)?

How Does It Differ from Traditional Paper-Based IFUs?

eIFU refers to the digital format of IFU documents that provide essential information on the safe and effective use of medical devices. Unlike traditional paper-based IFUs, eIFU is accessible online or via digital platforms, offering real-time updates and enhanced user experience. This transition to digital labeling aligns with the industry’s move toward automation and regulatory digitalization.

Regulatory Requirements for eIFU

Overview of EU MDR, FDA, and Global Regulations on Electronic Labeling

Regulatory authorities worldwide have recognized the benefits of electronic labeling and have set guidelines to govern its implementation:

EU MDR (Medical Device Regulation) mandates strict compliance with eIFU accessibility and security measures, ensuring users can access up-to-date information without compromising safety.
FDA (U.S. Food and Drug Administration) allows electronic labeling under specific conditions, particularly for professional-use medical devices, to ensure reliability and compliance.
Other Global Regulations include varying policies on electronic labeling, often requiring secure access, multilingual support, and data integrity.

Compliance Challenges and How eIFU Solutions Help Overcome Them

Frequent Updates: Keeping paper IFUs compliant with new regulations can be time-consuming and costly. eIFU enables real-time updates.
Global Accessibility: Ensuring multilingual support and digital access to IFUs can be complex. eIFU solutions provide a centralized platform for easy distribution.
Data Security: Regulatory bodies require secure access to prevent unauthorized modifications, which eIFU platforms can ensure with encryption and access controls.

Benefits of Implementing eIFU

Improved Accessibility and Real-Time Updates

eIFU allows users, including healthcare professionals and patients, to access the latest device instructions instantly via online platforms. This eliminates the risk of outdated information and ensures compliance with evolving regulations.

Cost Savings by Reducing Printing and Distribution Expenses

By transitioning to digital IFUs, manufacturers can significantly cut down on printing, storage, and distribution costs while contributing to environmental sustainability by reducing paper waste.

Enhanced User Experience for Healthcare Professionals and Patients

With easy search functionality, interactive features, and multilingual support, eIFU enhances the overall user experience, ensuring that critical medical device information is always within reach.

How Visu-eIFU Simplifies Electronic Labeling

Key Features of Visu-eIFU by DDi

Visu-eIFU is a cutting-edge solution designed to help medical device manufacturers meet regulatory requirements efficiently. Key features include:

Secure Digital Access: Ensuring compliance with global regulations while safeguarding data integrity.
Multilingual Support: Catering to global markets by providing IFUs in multiple languages.
Automated Updates: Real-time information updates without the need for reprinting and redistributing physical IFUs.

Case Studies or Examples of How Companies Have Benefited from Using Visu-eIFU

Several medical device companies have successfully transitioned to eIFU with Visu-eIFU, experiencing improved compliance, cost savings, and enhanced customer satisfaction. Case studies highlight:

A leading medical device manufacturer reduced labeling costs by 40% after adopting Visu-eIFU.
A global healthcare provider improved regulatory compliance by automating updates across multiple regions.

Future of Digital Labeling in the Medical Device Industry

Emerging Trends in Regulatory Digitalization

As technology continues to evolve, regulatory bodies are moving towards stricter compliance requirements for digital labeling. The adoption of eIFU is expected to grow as part of the broader digital transformation in the healthcare sector.

How AI and Automation Are Shaping the Future of eIFU

AI-powered eIFU solutions are paving the way for more intelligent and automated document management. From predictive updates to enhanced data analytics, AI will play a critical role in the future of digital labeling.

Conclusion

The shift to electronic IFU is no longer optional but a necessity for medical device companies aiming to enhance compliance and efficiency. Visu-eIFU by DDi provides a seamless solution for transitioning from traditional IFUs to digital formats, ensuring cost savings, real-time updates, and regulatory adherence.

Medical device manufacturers looking to stay ahead in regulatory compliance and operational efficiency should consider integrating eIFU solutions like Visu-eIFU into their labeling strategies. The future of medical device labeling is digital embracing it now will ensure long-term success and compliance.

Tags: eIFU, EU MDR, Medical device Labeling, Medical Devices, Medtech, Regulatory Compliance, Visu_eIFU

eIFU for Medical Devices: Country Specific Regulations and Benefits

Tue, 10 Sep 2024 10:53:47 +0000

There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including:

1. Accessibility: eIFUs can be accessed from anywhere with an internet connection, making them more accessible than paper-based instructions.

2. Timeliness: eIFUs can be updated more easily and quickly than paper-based instructions, ensuring that users always have access to the most up-to-date information.

3. Cost Savings: eIFUs can help reduce costs associated with printing, shipping, and distributing paper-based instructions.

4. Environmental Benefits: eIFUs can reduce paper waste and the environmental impact associated with the production and disposal of paper-based instructions.

5. User-friendliness: eIFUs can include interactive features such as videos, animations, and hyperlinks, which can make them more user-friendly and easier to understand than traditional paper-based instructions.

Overall, eIFUs offer a more convenient, efficient, and sustainable way to provide instructions for use of medical devices, while also improving accessibility and user experience.

Countries following eIFU	eIFU Required for MD?	Comments
USA	Yes	Required labeling for prescription devices intended for use in health care facilities or by a health care professional Required for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost. Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following: “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.” New Update – Acceptable Media for Electronic Product User Manuals As per New Update on August 20, 2024 the CDRH may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser performance data and other technical data related to safety of the product. These data are typically contained in user manuals that accompany electronic products. For example, 21 CFR 1020.30(h) and1040.10(h) specify information manufacturers must provide to users of diagnostic x-ray and laser products respectively with IFU. With the availability of electronic information storage and display technology, many commercial product manuals are being provided electronically. Electronic documentation saves storage space, reduces paper consumption, increases accessibility, and provides rapid means for editing and updating of content. For these reasons, manufacturers can provide the required user information in PDF format. Manufacturers may provide the required information as a web site download, on a compact disc (CD) or on other storage media in common use (e.g., USB external drive), so long as it is made available directly to the purchaser of the product. If the product purchaser is unable to access the electronic version provided, the manufacturer must make the required documentation available in hard copy (e.g., printed paper) at no additional cost. The manuals in whatever form provided should be in the English language.
Europe	Optional	According to Regulation (EU) 2021/2226, Article 3, instructions for use may be provided in the electronic format for the following types of devices, covered by Regulation MDR (EU) 2017/745 and intended for professional use only: 1. Implantable, and active implantable Medical Devices and associated accessories; 2. fixed installed Medical Devices and associated accessories; 3. Medical Devices and associated accessories with an integrated system for displaying instructions for use. On the other hand, with regards to software covered by MDR, Manufacturers can provide the instructions for use in the electronic format directly via the software itself. Lastly, the Implementing Regulation requires that Manufacturers make instructions for use available in their websites by indicating on the devices label that IFU are provided in the electronic format instead of the paper one. For in vitro diagnostic medical devices (IVDs): When the device is intended for professional use only, Instructions for Use may be provided to the user in non-paper format (e.g., electronic), except when the device is intended for near-patient testing. Users: Professional users only for a, b and c, consumer and professional users for d. Requirements: Risk assessment to be undertaken. Label to indicate that the IFU is supplied electronically, rather than paper. Paper must be available. Must maintain current and historical eIFU on their website for more than 15 years.
Australia	Optional	Eligible devices are limited to those intended for use by professional users, and not for supply to the general public (i.e. paper-form IFU is required and additional electronic IFU is optional for devices supplied to the general public). active implantable medical devices and their accessories implantable medical devices and their accessories fixed installed medical devices medical devices and their accessories fitted with a built-in system visually displaying the Instructions for Use standalone software. Users should always have the choice to obtain the content of the eIFU in paper form on request, without undue delay or within the time period specified in the risk assessment, and free of charge.
Canada	Optional	Health Canada considers e-labelling to refer to the information required by section 21(1) of the Regulations that would ordinarily be found in the directions for use. The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual. For devices that are not sold to the general public, this information may be provided as downloadable from the internet and/ or on electronic data storage devices.
Brazil	Yes (with some exceptions listed in Article 54 of RDC No. 751)	Article 54 The exclusive availability of instructions for use in non-printed format for the following products is prohibited: I – equipment for use in healthcare that is indicated for: a) domestic use in general, including use in home care services – SAD; It is b) operation by lay people, regardless of the place of use. II – materials for health use used by the lay public. III – in-vitro diagnostic products, comprising: a) self-test products; b) products used for remote laboratory testing; and c) patterns and calibrators.
Japan	Yes	In particular, for medical devices and in vitro diagnostics, posting the package inserts on the website, which had not been required, is now mandatory. Marketing Authorization Holders (MAHs) must register the information on the Safety Information Posting System located on the PMDA’s website for MAHs. The new Japanese regulation eliminates the ability to provide IFU (previously called “Tempu Bunsho”) in physical format for professional users. The new law requires all IFUs to be provided in electronic-only.
Saudi Arabia	Optional	MDS – G10: Guidance on Labelling Requirements for Medical Devices, Dated: 18-Jan-2015: Where the device is intended for use by lay persons, the IFU shall be provided in a paper format. Under the general rule, electronic Instructions For Use (eIFU) are allowed. At the same time, the medical device manufacturer shall ensure they are accessible for potential users of a medical device. Moreover, it should be clear for a potential user how the correct version could be found. Additionally, there should be an option to obtain the IFU in paper format. It is important to mention that eIFU is allowed only for medical devices intended to be used by healthcare professionals, while in the case of medical devices intended to be used by laypersons, the paper format is mandatory. Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5) specifies: Instructions for use may be provided to the user in non-paper format (e.g. electronic) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.
South Korea	Optional	MFDS notification 2018-500. This notification amended the Medical Device Act to specifically call out that providing required labeling via the internet is permitted. No other requirements were included in the notification, but only products which are specifically permitted per the notification may be eLabeled. Home-use labeling may not be eLabeled.
India	Optional	As Per CDSCO MDR 2017 the manufacturer must submit the instructions for use or electronic instructions for use to the Central Licensing Authority (CDSCO) as a part of registration process. In some cases, the CDSCO can request additional information regarding to eIFU. The eIFU should be in format that is easily accessible to users and must contain all the necessary information related to device. The Manufacturer must ensure that the eIFU is updated regularly and must submit eIFU to Central Licensing Authority (CDSCO) as part of the registration process. India does not have specific regulations for electronic instructions for use (eIFU). As Per G.S.R. 30, which went into effect on January 15, 2019, Electronic IFUs are now accepted by the CDSCO. As amended vide GSR 777(E) dt. 14-10-2022(w.e.f. 14-10-2022) which amended the Medical Devices Rules, 2017. These amendments allow manufacturers to provide either paper-based IFU or eIFU. Instructions for use can be provided as an electronic format downloadable from the internet.
Singapore	Optional	GN-23: Guidance on Labelling for Medical Devices – Dated: March 2020: For devices that are not sold to the general public, instructions for use may be provided to the user either in paper or non-paper format. They may be supplied by various means either with the medical device or separate from it. Examples are information downloadable from the internet and/or on electronic data storage devices (compact disc, digital video disc, USB flash drive, etc.).
Malaysia	Optional	MDA/GD/0026: REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES – Dated: 21 November 2022 Stated that: Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. Paper-form IFU is required and additional electronic IFU is optional for home use devices.

Want to stay ahead of the curve with eIFU labeling for medical devices? Learn about the benefits and regulations here.

Tags: Compliance, eIFU, eIFULabeling, Healthcare, Medical Devices, Medical Technology, MedicalSafety, Regulations

eIFU Requirements Under the EU MDR and Regulation 2021/2226

Wed, 17 Jul 2024 05:22:01 +0000

What is an eIFU?

In general, an eIFU is defined as a non-paper version of the instructions for use. Currently, the definition of an eIFU is not the same in each market.

In the EU, according to the Commission Implementing Regulation EU 2021/2226, which laid down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council in regards to electronic instructions for use of medical devices, instructions for use in electronic format means “instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through software or website.”

European eLabeling regulation 2021/2226

The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented by Implementing Regulation (EU) 2021/2226, the successor to Commission Regulation (EU) 207/2012.

Requirements for the use of electronic instructions for use as per regulation (EU) 2021/2226

According to Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met:

The device should fall into a specific class, as mentioned below:
- Implantable and active implantable medical devices and their accessories
- Fixed installed medical devices and their accessories
- Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use (e.g., ultrasound equipment)
The devices and accessories are intended for exclusive use by professional users
The use by other people is not reasonably foreseeable
For software, manufacturers may provide eIFUs within the software itself.

Manufacturers of Medical devices that provide instructions for use in electronic form to users instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements:

Knowledge and experience of the intended users in particular regarding the use of the device and user needs;
Characteristics of the environment in which the device will be used;
knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
Access of the user to the reasonably foreseeable electronic resources needed at the time of use;
Performance of safeguards to ensure that the electronic data and content are protected from tampering;
Safety and backup mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;
Foreseeable medical emergency situations requiring the provision of information in paper form;
Impact caused by the temporary unavailability of the specific website, of the internet in general, or of their access in the healthcare institution, as well as the safety measures available to cope with such a situation;
Evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request;
Assessment of the website’s compatibility with displaying the electronic instructions for use with different devices that could be used to display those instructions;
Management of different versions of the instructions for use, where applicable

Factors to consider when switching to an electronic IFU for your medical device

1. Risk assessment

eIFU must maintain or improve the level of safety compared to providing a paper IFU. Your risk assessment needs to examine this carefully. For instance, if your device is sometimes used by nurses or doctors in rural locations where the internet may be spotty, what additional risks might that present? You will need to update your risk management procedures and forms to account for this.

2. Product packaging

The location of the eIFU must be indicated on the packaging for each unit or, in the case of fixed devices, on the device itself. For obvious reasons, you cannot simply place PDFs of your IFU on your website and assume professional users will know to look there. The Regulation makes it clear that your packaging must clearly specify that the IFU is in electronic format and where it can be found. Except for software and devices with screens, the IFU may reside on a website, and its location may be communicated via a website URL or QR code. If you choose the latter, make sure you document the pros and cons of using QR codes in your risk assessment and update your labeling work instructions as needed.

3. Validation

Ensure the user’s access is precise by having accurate product data in real-time and a solution for delivering the information in the user’s preferred language.

4. Method of delivery

If you make software as a medical device (SaMD) or a device with a larger display screen, the method of delivery may be the device itself. For all other devices, device manufacturers will most likely deliver IFUs via their website. This fulfills a key requirement that the information be provided in a universally available format (thumb drives and DVDs are no longer universal). The preamble of the new eIFU regulation says, “To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates, those instructions should be available on the website of the manufacturer in an official language of the Union determined by the Member State in which the device is made available to the user or patient.” This does not mean you cannot deliver your eIFU on a private YouTube channel, for example.

5. Paper version

There are professionals out there who prefer paper-based instructions, or (it is true) might not have reliable internet access. It is EU law to have paper IFUs, with the exception of some devices. If a paper-based option is required, you are obligated to provide a paper version within seven calendar days of the request at no cost. In cases where video or animation is not used, the eIFU may simply be a printed copy of the PDF you maintain online. Make sure to update your labeling SOP with this requirement.

6. Online security

Making your IFU available online is easy. Ensuring that it does not accidentally get removed or replaced is not possible. You will need to put procedures in place to ensure that your sales and marketing departments do not change the URL, delete old versions, or otherwise change the document. You should really think of the master IFU web page(s) as controlled documents, not just the IFU itself.

7. Archival procedures

For devices without a defined expiration date, your IFU needs to be maintained for 15 years after the last device has been placed on the market. For devices with an expiration date, this changes to 10 years. You also need to have a system for indicating when changes have been made (change control) and a way to inform each user if the change was made for safety reasons. Finally, all historical versions of the IFU must be made available on the website.

8. Privacy policy

Europe has one of the strictest online privacy laws in the world, known simply as the GDPR (General Data Protection Regulation 2016/679). If you will be asking the user to provide their name and/or email, or if your website has cookies enabled (most do), you will need to make sure you are following the GDPR.

Advantages of eIFU over paper-based instructions:

Enhanced accessibility: considering the high internet coverage, electronic instructions can be accessed digitally and consulted anywhere, providing easier search and navigation and greater flexibility.
Real-time updates: eIFU allows for immediate updates and revisions, ensuring that users always have the latest information about the product they are using. This is crucial for patient safety and optimal device utilization.
User-friendly interfaces: Electronic formats enable the incorporation of multimedia elements, such as videos and interactive features, enhancing the clarity and effectiveness of instructions.
Increased efficiency in MDR implementation: electronic formats facilitate the inclusion of multiple languages and therefore contribute to reducing the risk of shortages of medical devices and improving the overall availability of these devices, especially in a multilingual context like the European Union.
Cost efficiency: Over time, the implementation of eIFU can lead to cost savings for both manufacturers and healthcare institutions, as the need for printing, distribution, storage, and waste management of paper IFU is significantly reduced.
Environmentally sustainable: The transition to eIFU aligns with broader efforts to reduce paper usage, contributing to environmental sustainability and supporting the EU Green Deal.

Going forward, manufacturers seeking to sell their products in the European market must comply with the EU eIFU regulations. Adhering to these regulations will provide greater flexibility and reduce the risk of product recalls related to IFUs. If you are in the process of updating your device labels and preparing eIFUs, feel free to contact DDi for expert assistance.

Tags: Digital Health, eIFU, eLabeling, Electronic IFU, EU Regulations, Health Tech, Healthcare Compliance, Healthcare Innovation, Medical Device Industry, Medical Device Regulation, Medical Device Safety, Medical Devices, Medtech, Patient Safety, Regulatory Affairs

Digitize Instructions for Use (IFU) to Comply with EU MDR

Wed, 13 Mar 2019 09:36:31 +0000

The regulation brings digital enablement to the forefront, compelling electronic instructions for use.

EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.

eIFU: Meaningful Requirement Improving Patient Safety

European MDR makes eIFU a requirement while supercharging it with a meaningful value proposition. eIFU improves patient safety by providing users with the most up-to-date information in their preferred language. In addition, eIFU can include video and audio files, making it easy to demonstrate operating and handling instructions through mobile devices. And, time to market with revisions or changes is much faster via electronic distribution; ensuring users access the most accurate information.

Complying with eIFU Requirements

To comply with and exploit the benefits of eIFU, a manufacturer should primarily complete a documented risk assessment that demonstrates eIFU maintains or increases safety compared to traditional IFU. Some of the additional requirements include:

Clearly specify on the product packaging of each unit that the instructions for use are provided in electronic rather than paper form. If it is a fixed medical device, this information should appear on the device itself.
Provide eIFUs in a universally available format and include information on the hardware and software requirements required to display them.
Develop alternate plan for users who do not have Internet access by providing a paper copy, upon request, of the IFU within seven days at no extra cost to the user.
Ensure eIFUs are available for at least two years after the expiry date of the last produced device or 15 years after the last manufactured device in case of implantable devices or devices without a defined expiry date.

Compliance with EU MDR and eIFU need major process redesign for many manufacturers. Documented risk assessments and quality management systems are a must for eIFU. If a manufacturer is considering outsourcing its eIFU, it is the sole responsibility of the manufacturer to maintain safety over the products, including supplemental materials according to new European Medical Device Regulations.

Manufacturers must ensure the information user access is precise. This means having accurate product data in real time and a solution for delivering the information in the user’s preferred language.

As digital enablement will soon be a requirement under MDR, manufacturers need a system like VISU with a centralized product repository with access to global product information and web based eIFU multi language portal to manage IFU updation and distribution globally, enabling the promise of improved patient safety and engagement is within reach.

Tags: eIFU, EU MDR Compliance, VISU