How to write Instructions for Use (IFU)

"Who reads the instructions or manual?" Quite often, this is the reaction people give when you ask if they have consulted the instructions for use. And it's not a weird reaction as we assume that whatever we buy is supposed to be easy to use and safe, right?! "We will figure it out by ourselves!" Anyone who has assembled a cupboard and found a few seemingly extra screws at the end of the process, knows that sometimes it's not a bad idea to look into the instructions. If we are talking about medical devices, it's easier to imagine that knowing what the device is made for and how it should be operated, is critical.

In this article we delve a bit deeper to understand the true purpose of an instruction for use and what to pay attention to when writing one.

What Is An Instruction for Use?

In the MDR, the following definition appears:

‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken; 

The MDR states that IFU is required for all class IIb and class III medical devices, while class I and class IIa medical devices are exempted if the devices can be used safely without any instructions. This shows how closely an IFU is linked to the risk analysis of the device, but as well the usability of the device.

Objectives of Instructions for Use

Instructions for Use (IFU) serve as a vital bridge between a product and its user, ensuring seamless interaction and optimal performance. At its core, an IFU aims to provide clarity, guidance, and safety precautions to users. It acts as a roadmap, facilitating the user in understanding the product's functionality, operation, maintenance, and troubleshooting procedures.

Benefits Of Having An Effective IFU

An effective IFU holds myriad benefits for both the manufacturer and the end-user. Firstly, it enhances user experience by simplifying complex processes, reducing confusion, and minimizing errors. Secondly, it fosters product reliability and safety, thereby mitigating risks and liabilities for the manufacturer. Moreover, a well-crafted IFU can bolster brand reputation, instilling trust and loyalty among consumers. Overall, it serves as a cornerstone for successful product utilization and customer satisfaction.

How To Write An IFU?

Creating a comprehensive IFU requires meticulous attention to detail and adherence to industry standards. Below are essential elements to consider when crafting an IFU:

Intended Use

Define the primary purpose of the product and outline its intended applications. This is a must for medical devices. Clarify any limitations or restrictions on usage to prevent misuse or safety hazards.

Risk Management

Conduct a thorough risk assessment to identify potential hazards associated with the product. Incorporate clear warnings, precautions, and safety measures that are defined as outcome of the risk management activities to ensure user safety.

Standard Documentation

Ensure to incorporate all information described in the relevant and applicable regulations. Make sure to use the correct symbols and to explain them. Furthermore, using clear language, concise instructions, and visual aids to enhance readability and comprehension, leads to a more effective IFU.

Depending on the targeted markets, there will be specific language requirements. The specific language requirements under the MDR can be found here.

General Safety and Performance Requirements (GSPR)

Together with the label, the instructions for use are considered to be the "Information provided by the manufacturer". Annex I (the GSPR), Chapter 3, §23 of the MDR defines the requirements for these instructions for use in details. 

Next to the requirements defined in this section of the MDR, there are additional requirements for those who want to provide the IFU in an electronic format. 

Legal Regulations

Ensure compliance with relevant regulatory requirements, standards, and directives applicable to the product. Include necessary disclaimers, warranty information, and regulatory certifications to meet legal obligations. It's important to ensure that all applicable requirements are implemented for all regions or markets that you want to target. It is allowed to have one IFU that covers multiple countries, but it's important to make sure all requirements are covered.

Product Specifications

Detail the product's specifications, features, and functionalities to help users understand its capabilities and limitations. Include technical specifications, operating parameters, and compatibility requirements for optimal performance.

Differences Between a User Manual and IFU

While both serve as instructional guides, there are distinct differences between a user manual and an IFU. A user manual typically provides comprehensive information about the product, including setup, operation, troubleshooting, and maintenance procedures. It caters to both novice and experienced users, offering in-depth insights into product functionality and features.

On the other hand, an IFU focuses primarily on essential instructions for safe and proper use of the product. It emphasizes safety precautions, warnings, and regulatory compliance, targeting users who may be unfamiliar with the product or its associated risks. Unlike a user manual, an IFU prioritizes simplicity, clarity, and usability, focusing on critical information necessary for user safety and product efficacy.

Depending on the device, one might opt one or the other, but in any case all regulatory requirements need to be fulfilled.

Conclusion

In conclusion, mastering the art of instruction for use is essential for ensuring product usability, safety, and regulatory compliance. By following established guidelines and best practices, manufacturers can create effective IFUs that enhance user experience, mitigate risks, and uphold industry standards.

The IFU is one piece of the medical device which needs to be documented in the design of your device. MatrixALM offers you a platform where you can document the complete design, risk management and testing of your device, ensuring complete traceability throughout the whole design documentation and facilitating the creation of compliant documentation. If you'd like to see more, don't hesitate to book a demo!