What is an IFU and what is an eIFU (electronic instructions for use)?
Instructions for use refer to the details that a medical device manufacturer provides to users regarding the purpose of the device, how to use it properly, and any safety precautions that should be followed.
The “e” in eIFU refers to the electronic delivery method for instructions, which can vary depending on the device and it is not provided in paper form.
Benefits of eIFU:
- Reduced Paper Costs and Waste.
- Quicker updates to instructions.
- A reduction in the possibility that the supply chain contains out-of-date IFUs.
- A greater concentration on using video and animation to demonstrate how to use the device.
What are the factors to consider when switching to an electronic IFU for your medical device?
Implementation of Regulation (EU) 2021/2226 specifies that if the following requirements are met, then instructions for use (eIFU) may be provided electronically instead of on paper.
The device falls into a specific class:
- Implantable and active implantable medical devices and their accessories
- Fixed installed medical devices and their accessories
- Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use (e.g., ultrasound equipment)
Risk Assessment:
Article 5 of the draft regulation mandates that an eIFU must enhance safety compared to paper IFUs. A careful risk assessment (Article 4) is necessary to consider additional risks, such as potential internet issues in rural areas, and update risk management procedures and forms accordingly.
Product Packaging & Labeling:
Article 6 of the regulation mandates that the location of electronic IFUs (eIFUs) must be clearly indicated on the packaging for each unit or on the device itself. This is different from simply placing PDFs on a website, as professional users may not know where to find them. IFUs may be located on a website, but must be communicated via a website URL or QR code. If using QR codes, document the pros and cons and update labeling work instructions.
Paper Versions:
Some professionals prefer paper-based instructions or lack reliable internet access. EU law requires paper IFUs, except for some devices. If paper-based is required, a paper version must be provided within seven days of request at no cost. If video or animation is not used, an eIFU may be a printed copy of the PDF. It is important to update the labeling SOP with this requirement.
Security On The Web:
To ensure the safety of your IFU online, it’s crucial to implement procedures to prevent accidental changes or replacements. Sales and marketing departments should not alter the URL, delete old versions, or alter the document. The master IFU web page should be considered a controlled document, not just the IFU itself.
Validations:
Make sure the user has precise access to the product by providing real-time, accurate product data and a way to provide the information in the user’s language of preference.
Storage & Maintenance Of e-IFU Data:
In the case of devices without a specified expiration date, you must keep your IFU for 15 years following the last device’s release onto the market. This is changed to 10 years for products that have an expiration date. Additionally, as stated in Article 5(12), you must have a change control system in place that informs each user when changes have been made and notifies them if such changes were made for safety. Lastly, the website needs to maintain all previous versions of the IFU.
Right To Privacy:
The GDPR (General Data Protection Regulation 2016/679), a stringent online privacy law in Europe, mandates websites to ensure user information is collected and processed securely. If users provide personal information or have cookies enabled, it is crucial to comply with GDPR guidelines, which can be confirmed by the website administrator.
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