In a world where products and processes are being digitalized, and sustainability is getting more and more important, regulatory authorities and Notified Bodies now consider that in certain circumstances the provision of instructions for use (IFUs) may be undertaken electronically. If you look at the worldwide medical device market, it is visible that more countries publish regulations and/or guidance about electronic IFUs (eIFUs).
We see a trend emerging where eIFUs are being recognized and accepted in a variety of healthcare markets. This will continue to evolve over the next couple of years in which more and more countries will recognize eIFUs, however, the use of eIFUs may never become a risk to the patient and therefore differences between markets are insurmountable.
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 and 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.”
In the US, according to the FDA, the Center for Devices and Radiological Health (CDRH), will allow manufacturers to provide the required user information in a commonly used electronic format (e.g., Adobe Acrobat or Rich Text Format). Manufacturers may provide the required information as a website download, on a compact disc (CD), or another storage media in common use (e.g., USB external drive), as long as it is made available directly to the purchaser of the product.
What are the advantages/disadvantages of using eIFUs instead of paper?
The most important advantage from a user/patient usability prospective is improved readability & usability. Paper IFUs are usually hard to read, unclear, and far from user-friendly. This is often the result of limited layout space and font size as manufacturers try to squeeze as much information as possible into the available space. Layout limitations are of the past with eIFUs, as manufacturers have enough space to improve the design and user experience by implementing more advanced and interactive designs such as animations or voice prompts. Moreover, users can select a preferred language instead of wasting time searching for the relevant sections across multiple pages.
Another positive aspect of replacing the paper IFU with electronic is less environmental impact & reduced costs. Saving money on paper, ink, and printing costs is one reason to consider eIFU, on the other hand, these savings have a positive impact on the environment with respect to aspects such as material waste, production energy, and transportation. Moreover, with the paper versions being removed from the packaging, boxes may be reduced in size, resulting in potential further savings on packaging materials and warehouse capacity.
The third advantage is reducing the risks of error. By taking away the step of adding the correct version of the IFU to the correct box, the risk of errors that may occur at this stage can be eliminated. Such errors could potentially lead to expensive IFU/product recalls or replacements, potentially creating immense stress on the supply chain and stock management. Normally, such events would be reduced by standard control procedures to make sure the correct IFU is in the correct box, but with the implementation of the eIFU, none of these procedures are required. Additionally, with eIFUs for manufacturers, extracting or updating sections in the IFU to improve usability is more effortless. Consequently, patient safety can potentially be improved due to the reduction or even elimination of certain errors.
On the other hand, the implementation of the eIFUs creates additional work and requires more resources. Many companies have already encountered issues with resources during their day-to-day activities, let alone if extra resources are required due to the implementation of eIFUs. Manufacturers need to determine the impact of eIFU implementation and check if they have enough resources to deal with the extra amount of work. In addition, manufacturers shall consider the possible risks associated with using electronic instructions for use and incorporate them in the device risk analysis.
To what extent are eIFUs accepted worldwide and under which conditions?
For the EU, the eIFU allowance requirements are clearly stated in the Implementing Regulation 2021/2226. However, it’s interesting to see how eIFUs are accepted in the rest of the world and under which conditions. Based on an analysis of the eIFU requirements for more than 40 countries worldwide, we see that there are three main approaches to eIFU applicability/acceptability.
Let’s discuss three different approaches:
- It is either allowed for all types of medical devices to replace the paper version of the IFU with an eIFU or for none. In cases where eIFUs are not accepted for any medical device type, the regulatory authority explicitly do not accept the implementation of eIFUs at all or they do not have an official regulation or guidance published yet.
- The implementation of the eIFU is eligible for devices limited to those intended for use by professional users and not for supply to the general public. For the public, a paper version is mandatory and the use of an additional eIFU is optional. Moreover, users should always have the choice to obtain the eIFU content in a paper version, without undue delay or within the time period specified in the risk assessment, and free of charge. This is an approach which many regulators take.
- The third approach is to determine the applicability of an eIFU by the type of device. This approach has been adopted by regulators such as the Medicines and Healthcare products Regulatory Agency (UK), General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device Services (Turkey), by the European Union and is published in the implementing regulation 2021/2226. Under Article 3 those are the following devices:
a. implantable and active implantable medical devices covered by Regulation (EU) 2017/745;
b. fixed installed devices covered by Regulation (EU) 2017/745;
c. medical devices and their accessories (covered by Regulation (EU) 2017/745) and fitted with a built-in system visually displaying the instructions for use.
Manufacturers of software covered by Regulation (EU) 2017/745 may provide instructions for use in electronic form too by the means of the software itself instead of in paper version.
If it is accepted to implement the eIFU instead of the paper version consequently, additional requirements are often involved. These include the following requirements that the legal manufacturer shall undertake/implement:
• Shall have a documented risk assessment.
• Provide IFU in electric form in all member states where the product is made available.
• eIFU shall be available in the member state language in which the device is made available.
• Shall have a system in place to provide IFU in paper form at no additional cost for the user.
• Ensure proper design, usability, and functioning of the eIFU and provide verification and validation evidence to this effect.
• Provide information on software and hardware requirements needed to display the eIFU.
• Have a system in place to clearly indicate when IFU has been revised and inform each user of the device thereof if a revision was necessary for safety reasons.
• Shall make available all historical issued electronic versions of the IFU on the website.
• Shall indicate on the label that IFU is supplied in electronic form instead of paper form.
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