Medical Device IFU & eIFU
IFU & eIFU Requirements Under the EU MDR
A Medical Device IFU and user manual must be easy to use and understand. To do this, manufacturers need a well-thought-out plan and a technical writer who knows how to put together IFUs. It is important to remember that IFUs and manuals are used to tell the user how to use your device safely. Medical devices affect patients’ health, and so it is important that IFUs are easy to understand.
Chapter III, section 23.4 of the new European regulation, outlines the expected IFU structure. Before, when the MDD was in place, there were no outlines. The implication is that companies can’t just reuse the IFUs from their old products or use the IFUs that the FDA has already approved.
What must the IFU contain under the EU MDR?
The Medical Device IFU is an essential part of your CE marking documentation, no matter which country you’re applying for. Ensure your regulatory department outlines what is required for each region, as requirements differ. The new European regulations have a set structure with its own unique terminology. It requires the following key elements:
- The name or trade name of the device.
- The name, registered trade name or registered trademark, and address of the company that made the product.
- If applicable, a symbol that the device contains or has a medicine, such as something made from human blood or plasma, or human-made tissues or cells or things made from them.
- If the device is sterile, it must show the sterilisation method.
- If the device is single, use.
- If they make the device of substances or mixtures of substances that are injected into the body through an orifice in the body, applied to the skin, and then absorbed by or distributed locally.
The device’s intended purpose.
- Indications, contra-indications, the patient target groups, and the intended users.
- The clinical benefits to be expected.
- Summary of safety and performance.
- Device performance characteristics.
- Information to confirm the device is suitable and its accessories.
- Any risks and the information the patient needs to know.
- Specifications the user needs to know to use the device appropriately.
- Details of any preparatory treatment or handling of the device.
- Requirements for facilities, training, or qualifications of the user.
- The information needed to confirm successful installation.
- Maintenance needs.
- Cleaning and/or disinfection needs.
- Identifying consumable components and how to replace them.
- Information about calibration.
- How to ensure the device operates properly and safely during its intended lifetime.
- Sterility status and instructions if they compromised sterility.
- If applicable, instructions for sterilisation.
- Instructions for device reuse.
- When a lay user should consult a healthcare professional.
- Date of issue of the instructions for use, and update history with dates.
- How to report serious side effects with the device.
- Hardware, IT network characteristics, and IT security needs.
European eIFU regulatory considerations
The European Union’s eIFU regulation states that the following devices are suitable for eIFUs:
- Devices and accessories only used by professionals.
- Software (paper option not required).
- Devices with built-in screen displays (paper option never required).
- Fixed installed medical devices (paper option never required if the device has a screen).
- Implantable devices (paper option not required).
Keep in mind that Class I and IIa devices do not need any instructions for use if the device use is safe without it.
Factors to consider when switching to an electronic IFU for your medical device
Many medical device manufacturers already have a PDF of their IFU and the challenge now is to ensure it meets the EU MDR and the new eIFU legislation. Here is what you need:
1 – Risk Assessment
Under Article 5, an electronic IFU must keep or improve the safety compared to a paper version. Manufacturers must discuss this in their risk assessment (see Article 4).
2 – Product Packaging
According to Article 6, the packaging, or the actual device must contain information on the eIFUs location. Article 6 states your packaging must make it clear where the eIFU is available.
3 – Validation
Ensure that there is real-time correct product data and a copy of the user’s selected language to ensure user access.
4 – Method of Delivery
It is essential that the eIFU is accessible. The device itself may serve as the mechanism of delivery with software as a medical device (SaMD) or a device with a larger display screen. Manufacturers of other devices will use their websites. Note you can also use other channels, such as delivering your eIFU on a private YouTube channel.
5 – Paper Version
EU law requires paper IFUs, with a few devices being an exception. Manufacturers must deliver a physical copy without charge and within seven calendar days of the request.
6 – Online Security
Ensure your eIFU doesn’t unintentionally get taken off or replaced. Set up protocols to ensure that your marketing and sales teams don’t alter the URL, remove previous versions or do anything else to the document. Treat your eIFU web page as a controlled document.
7 – Archiving Procedures
You must keep IFUs for 15 years following the release of the last device. Manufacturers must have a method of notifying users of changes and a way to notify them to advise if the modification was necessary for their safety.
8 – Privacy Policy
Ensure you are adhering to the GDPR if you plan to request the user’s name and/or email, or if your website has cookies enabled. Ask the website manager for further help with this.
Dealing with paper copies of an IFU
When a medical device IFU is available electronically, professional users rarely ask for a printed copy. Most customers will go to the website, download a PDF, and print it themselves. Do you need to keep hard copies of your IFU on hand? Perhaps not. If the customer wants a copy, but doesn’t want it emailed, you could print it on demand using the PDF and send it to them within seven days.
CLIN-r+ recommendations
Switching your IFUs and/or manuals to the MDR can be a daunting task. It is important not to reuse your previous IFUs and manuals, but to work through the list of requirements methodically in relation to your device.
We hope the information in this document helps you transition your IFUs and/or manuals to the EU MDR. Should you have any questions or need professional assistance, CLIN-r+ has a wealth of experience to call upon. Get in touch!
