Under the EU MDR (EU 2017/745) and IVDR (EU 2017/746) , all medical devices must have an Instructions for Use (IFU) that describes the device’s intended purpose, use, proper maintenance, and potential risks. The IFU must also include detailed information on how to safely use the device and how to manage any risks associated with its use as needed in Medical device lFU. The medical device IFU must also provide information on the device’s shelf life, storage requirements, and any applicable warnings and precautions. In case of active devices this is often referred to as user manual.
The IFU (Instructions for Use) for medical devices or user manual incase of active devices must meet the requirements laid out in Annex I, Section 1.6 of the European Medical Device Regulation (MDR). In particular, the medical device IFU must provide clear and detailed instructions for the safe and appropriate use of the device, including:
- Intended purpose of the device
- Description of the device
- Description of any accessories or components necessary for the device to functio
- Warnings and precautions to be taken when using the device
- Proper maintenance and cleaning instructions
- Proper disposal instructions
- Instructions for dealing with errors or malfunctions
- Contact information for the manufacturer in case of queries, complaints or adverse events
- Any other information necessary for safe and appropriate use of the device.
The following steps should be followed to prepare an medical device IFU for a medical device as per in EU MDR:
- Ensure that the device meets all relevant safety and quality requirements.
- Collect all relevant information about the device, including technical specifications, device performance, risk management documentation, and clinical evidence.
- Consult the applicable standards and regulations to ensure the medical device IFU is in compliance.
- Write the IFU in a clear and concise manner, using simple language and avoiding technical jargon where possible and including Medical device labeling requirement.
- Include diagrams and illustrations to supplement the text and make the instructions easier to understand.
- Include clear warnings and cautionary statements to alert the user to potential risks.
- Include instructions for safe storage, maintenance, and disposal of the device.
- Include information about the manufacturer, contact details, and instructions for how to obtain additional information.
- Have the medical device IFU reviewed by an expert familiar with the device and its use.
- Submit the IFU to the relevant national authority for approval.
- Upload the IFU to the company website in the electronic format for easy access.
For further information you can refer – how to prepare medical device IFU based on international standards
FAQ:
- EN ISO 15223-1:2012: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
- EN 1041:2008: Information supplied by the manufacturer of medical devices.
- EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
- EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.
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
