Information For Use (IFU) Labels

Royal Label provides validated IFU (Instructions for Use) printing solutions that support both regulatory compliance and user safety. In addition to our label printing services, we deliver FDA-compliant IFU documents designed for a variety of medical devices, prescription products, and packaging types.

What Is an IFU for Medical Devices?

An IFU (Instructions for Use) is a critical document that provides essential information about the safe and effective use of a medical product. These instructions are required by regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, under standards like 21 CFR Part 801.5, ISO 20417, and EU MDR.

Each IFU typically includes:

• Instructions for use
• Manufacturer information
• Material disclosures and labeling requirements
• The intended use and function of the product
• How to properly store and maintain the product
• Any warnings, restrictions, or residual risks

Who Are IFUs For?

IFUs are designed for both healthcare professionals and everyday users. Depending on the product, you may need to include separate IFUs tailored to different audiences. These documents help reduce the risk of medical errors, improve patient safety, and ensure users understand how to operate or dispose of medical products properly.

At Royal Label, we have the ability to print multiple language IFU’s to serve your diverse customer base. Our processes are fully documented from order entry through shipping. We provide a first article proof and consult on the best layout to fit within a single sheet, folded sheet, or booklet.

Durable IFUs for Medical Devices

Medical device IFUs must be legible, long-lasting, and compact enough to fit into tight packaging. Our speciality printing processes ensure your IFU stays intact and readable throughout the device’s lifecycle, even with frequent use or exposure to sterilization procedures.

Royal Label is able to provide high-quality IFUs that will last the lifetime of the medical device and be able to withstand heavy use over time. Some of the medical device IFUs we print include:

• Surgical instruments
• Blood glucose monitors
• Heart monitors and diagnostic equipment
• Tubing, catheters, and needles
• Implantable and wearable devices
• And more!

IFUs for Pharmaceuticals & Prescription Products

Every prescription product must include an IFU document that follows strict FDA labeling requirements. These IFUs deliver critical information to patients, including:

• Safe usage instructions
• Allergy warnings, contraindications, and potential risks
• Proper disposal methods
• Storage conditions and expiration guidance

Our team understands the specific size and readability requirements that prescription IFUs demand. We’ll work with your regulatory and packaging teams to design space-efficient layouts that maintain clarity without sacrificing compliance.

IFU Design Best Practices

Creating effective Instruction of Use (IFUs) requires more than just regulatory knowledge; it demands a user-centered approach and high design standards. Whether developing content for prescription drugs or complex surgical instruments, the IFU must be clear, durable, and accessible.
Below are key best practices for ensuring your IFU document meets the expectations of regulators and users alike:

• Prioritize User Experience: IFUs should be organized in a step-by-step instructional hierarchy, enabling clinical users and patients to locate the information they need easily. Headings, subheadings, and bullet points enhance navigation, particularly in fast-paced healthcare settings. 
• Use Clear Visuals and Diagrams: Where applicable, include visuals of drug product components or device parts to reduce misinterpretation. Illustrations can enhance understanding for users with limited technical backgrounds. 
• Maintain Legibility: Fonts should be easily readable at small sizes, and layouts must consider those with visual impairments. Contract, font style, and spacing all play a role in minimizing medical errors. 
• Plan for Multiple Languages: IFUs often serve a global customer base. Preparing versions that meet regulatory framework requirements across regions, such as the EU MDR, Regulation 2021/2226, or the U.S. Food and Drug Administration’s 21 CFR Part 801.5, means developing clear digital instructions and translated labels. 
• Leverage Content Management Systems: A centralized system makes it easier to manage IFU versions, translations, and updates. This is especially useful when managing labeling across multiple product lines or facility types. 
• Durability and Compliance: The physical format, whether a folded sheet, booklet, or package insert, must withstand regular handling in sterile processing departments, hospitals, or home environments. Royal Label ensures materials meet these demands while staying compliant with regulatory guidance and quality standards.

Why Partner with Royal Label for IFU Printing?

With over 60 years of printing experience and successful audits by healthcare clients, Royal Label is a trusted IFU printing partner for medical device manufacturers and pharmaceutical companies. We help you:

• Comply with U.S. and global IFU labeling standards
• Meet patient safety and risk communication needs
• Streamline your document workflows and content management systems
• Customize durable, regulatory-ready IFUs for any product type

To learn more about how we can design and print IFUs for you, please call Marychristine Clifford at 1-617-825-6050 x 105 or visit our contact us page today!