IFU (Instructions for Use): Documentation in Pharma & Life Sciences

Every minute spent on outdated IFU methods is a potential liability. As your organization scales, these practices jeopardize compliance. Why not modernize your instructions for use process with Paligo CCMS?

We offer an industry-leading solution with years of experience providing leading pharma and life science companies with easy-to-use CCMS. It will drive efficiency, reduce hidden costs, and convert regulatory challenges into strategic advantages. Continue reading to find valuable information about how to write instructions for use.

Before diving into the topic of IFU in Pharma, let’s address some of the most common questions about it.

Clear instructions for use protect both users and manufacturers. Correct instructions prevent injuries and save lives by promoting the proper use of medical devices and prescription drugs. Well-written IFUs also reduce manufacturer liability by demonstrating due diligence in user safety.

Beyond safety, effective IFUs drive successful product adoption. Clear instructions help users apply medical products more correctly and consistently. This leads to better treatment outcomes and increased trust in the manufacturer.

Quality IFUs serve as valuable educational resources. Healthcare providers use IFUs to train their staff effectively. In-home care settings, caregivers depend on these instructions for proper patient care. Patients themselves rely on IFUs for safe self-administration of treatments. Through clear guidance, these documents build user confidence and minimize the risk of medical errors.

Creating a clear and compliant IFU requires a systematic approach. Follow these key steps to ensure your instructions for use meet both user needs and regulatory requirements.

• Intended Use: Define the purpose of your device according to ISO standards. Clearly state what the device is designed to do, and tailor the language to your target audience.
• Usability Engineering: Apply usability engineering principles (per IEC 62366). The principles will help you to design an IFU that is easy to follow. Organize your content to enhance user safety and comprehension.
• Risk Management: Identify potential risks from normal use and misuse. Include warnings and precautions to mitigate these risks, ensuring users are well-informed.
• Reference Standards: Incorporate relevant standards related to medical devices in your instructions for use. A few such standards are EN 1041/ISO 20417 and EN ISO 15223-1. By including these kinds of standards, you ensure your IFU meets industry guidelines. Align your content with FDA guidance when applicable.
• General Safety & Performance Requirements: Provide vital safety information, such as the device’s registered trade name, trademark, and CE mark. Further, include required details about medicinal substances.
• Regulatory & Legal Considerations: Add necessary legal statements to your instructions for use. Some examples are disclaimers, copyright notices, and trademark information. In this way, you can protect your organization and ensure compliance.
• Technical Specifications: Include key product details such as dimensions, operating conditions, and performance data.

Working with IFUs is about more than meeting regulatory requirements. It’s about protecting patients, boosting adoption rates, and preventing avoidable errors.

Clear, step-by-step instructions reduce the risk of misuse. The instructions help both healthcare professionals and patients feel confident using your product. Well-structured instructions improve their user experience. Below are key aspects to keep in mind when you and your technical writing team prepare the documentation:

• Use a sans-serif style font.
• The font size should not be smaller than 10pt.
• Use bold for the title, headings, figure titles and step numbers.
• An IFU for medical devices should be in bold and upper case letters.

By focusing on patient safety and clarity, you will achieve two things. You will both communicate that you value the user’s well-being, and you will form long-term confidence from the customer.

An IFU is a specific procedure to accomplish a task, which can exist as a standalone document or within a user manual. User manuals serve as comprehensive references, while an IFU can cover operation, maintenance, and design theory, as well as include various guides and instructions. For medical devices, they provide step-by-step guidance on performing individual tasks safely and effectively.

Every market sets its standards for IFU for medical devices and pharmaceuticals. For example, FDA requirements differ from those in the EU, and many companies must follow ISO guidelines.

Extra rules, such as those from the FFDCA, The Federal Food, Drug, and Cosmetic Act, and the EU Medical Devices Directive, add to the challenge. Regulatory changes – like updates on adverse effects and warnings – happen frequently.

As regulations keep changing, managing IFU documentation with traditional methods like PDFs and paper files creates risks. A modern Component Content Management System (CCMS) helps solve these challenges through:

• Centralized Content Management: Store all IFU documentation, safety summaries, and clinical evaluation reports in one secure location.
• Version Control: Track changes and maintain audit trails across departments.
• Smart Content Reuse: Organize content as reusable components to maintain consistency.
• Collaborative Workflow: Enable legal, marketing, and technical teams to work from a single source of truth.
• Global Compliance: Quickly update and translate documentation as regulations change.

Paligo’s cloud-based CCMS helps organizations like yours streamline the IFU documentation process. Our platform uses a topic-based, XML-driven approach to organize content as reusable building blocks.

This method lets your technical writers focus on creating clear, compliant content. As a result, your IFU product descriptions and other technical documentation remain consistent and compliant across markets through smart content reuse.