Medical Device IFU

Usage of symbols in labels helps to communicate quickly which are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device. As labels provide critical risk/benefit information as well as clear instruction for safe use. These symbols used in labels are also used in other range of formats like leaflets, user manuals, brochures.

• Marketing materials like leaflets and brochures
• Product packaging
• Product description
• User manuals
• Safety instruction
• Accompanying software

An Instruction for Use (IFU) is a document provided with a medical device that gives users detailed information on how to safely and effectively use the device, including the device’s intended purpose, description, proper usage guidelines, maintenance and cleaning instructions, warnings and precautions, storage and disposal details, and manufacturer contact information. The IFU ensures users understand how to operate the device correctly and manage any potential risks to guarantee patient safety and compliance with regulatory requirements like EU Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Incase of active devices, it is called a user manual.

Yes, the FDA requires Instructions for Use (IFU) as part of medical device labeling, especially for devices that are complex, implantable, diagnostic, or require user guidance for safe and effective use. The requirement is outlined in 21 CFR Part 801 and, for IVDs, in 21 CFR Part 809. An FDA-compliant IFU must include intended use, directions for use, warnings, precautions, contraindications, and manufacturer information. While the term “IFU” isn’t always used, these instructions are considered essential labeling. The FDA also provides guidance documents to help manufacturers create clear, accurate, and user-friendly IFUs based on device type and risk.

The MDR IFU guidance refers to the requirements under the European Medical Device Regulation (EU 2017/745) that medical devices must include in the IFU. It must clearly describe the device’s intended purpose, use instructions, maintenance, storage, disposal, and any associated risks or precautions. It should include information about the device’s components, accessories, shelf life, and manufacturer contact details. Annex I, Chapter III, Section 23 outlines what must be included in the information supplied with the device. For implantable and high-risk devices, IFUs are mandatory. IFUs must be in the official language(s) of the EU Member State where the device is used. eIFU allowed under certain conditions, per Commission Regulation (EU) 2021/2226.

A medical device’s Instructions for Use (IFU) must clearly provide the following information:

1. The intended purpose of the device

2. A description of the device and any necessary accessories or components

3. Warnings and precautions

4. Instructions for proper use, maintenance, and cleaning

5. Guidance on safe storage and disposal of the device

6. Steps to handle errors or malfunctions

7. Contact information for the manufacturer for communication

Any additional information required for safe and appropriate use, including device shelf life and storage conditions

Where applicable, diagrams or illustrations to aid understanding

This must comply with the requirements outlined in Annex I, Section 1.6 of the EU Medical Device Regulation (MDR) and be written clearly, avoiding technical jargon for easy user comprehension.

Maven provides end-to-end support in preparing Instructions for Use (IFU) that meet the stringent requirements of the EU MDR (2017/745) and IVDR (2017/746). Our team ensures that your IFU clearly communicates the device’s intended purpose, usage instructions, maintenance procedures, risk warnings, storage conditions, and disposal guidelines in compliance with Annex I, Section 1.6 of the regulation.

We assist with:

1. Gathering and organising technical and clinical information

2. Drafting user-friendly, regulation-compliant content

3. Integrating required medical device symbols and labelling elements

4. Including relevant illustrations and warnings

5. Reviewing the IFU for regulatory accuracy and clarity

6. Supporting translations and electronic formats for E-IFU requirements

Maven Profcon Services LLP ensures your IFU is clear, complete, and CE-ready.