QA/RA Consulting, Auditing & Training
The last time you purchased a product on Amazon, I am sure you eagerly opened the box and immediately sat down to thoroughly study the accompanying instructions for use (IFU), right? All joking aside, the instructions for use that ride along with medical devices are far from an afterthought. In fact, they are pretty darn important for patient and user safety and a key focus of your risk management efforts.
Increasingly, manufacturers are opting to distribute IFUs electronically on websites, secure portals, or device screen displays. The benefits of this so-called medical device “elabeling” to the manufacturer are significant:
The European Union has allowed electronic instructions for use (eIFUs) since March 2013 with Regulation 207/2012. On December 15, 2021, the European Commission published in the Official Journal the new regulation (EU) 2021/2226 on rules for the application of regulation (EU) 2017/745 regarding electronic instructions for use of medical devices. This new regulation establishes the conditions under which instructions for use of certain medical devices subject to the EU MDR can be provided in electronic form instead of paper form.
Regulation 207/2012 is repealed, however, it remains applicable for medical devices subject to Article 120 of regulation (EU) 2017/745 until the end of validity of certificates issued under Directives 90/385/EEC and 93/42/EEC. In otherwards regulation 207/2012 remains applicable to legacy devices, those certified under the Medical Devices Directives and placed on the market or put into service until transitional periods noted in regulation (EU) 2023/607.
This article covers the recommendations set forth in regulation (EU) 2021/2226 which replaces Regulation 207/2012. Let us take a closer look.
No. Article 3 of the European Union’s eIFU regulation states that they can only be used for the following types of devices:
Also, it is important to keep in mind that Annex I, Chapter III, 23.1(d) of the EU MDR says that Class I and IIa devices do not require instructions for use at all if they can be safely used without instructions.
With the exception of software, many medical device manufacturers already have a PDF of their IFU. So, the question then becomes not how to do it but how to ensure you are doing so in compliance with the EU MDR and the new eIFU regulation. Here is what you need to consider.
Article 5 of the draft regulation stipulates that an eIFU must maintain or improve the level of safety compared to providing a paper IFU. Your risk assessment (see Article 4) needs to examine this carefully. For instance, if your device is sometimes used by nurses or doctors in rural locations where internet may be spotty, what additional risks might that present? You will need to update your risk management procedures and forms to account for this.
Article 6 indicates that the location of the eIFU must be indicated on the packaging for each unit or, in the case of fixed devices, on the device itself. For obvious reasons, you cannot simply place PDFs of your IFU on your website and assume professional users will know to look there. Article 6 of the regulation makes clear that your packaging must clearly specify that the IFU is in an electronic format and where it can be found. Except for software and devices with screens, the IFU may reside on a website and its location may be communicated via a website URL or QR code. If you choose the latter, make sure you document the pros and cons of using QR codes in your risk assessment and update your labeling work instruction as needed.
Ensure the user access is precise by having accurate product data in real-time and a solution for delivering the information in the user’s preferred language.
If you make software as a medical device (SaMD) or a device with a larger display screen, the method of delivery may be the device itself. For all other devices, device manufacturers will most likely deliver IFUs via their website. This fulfills a key requirement that the information be provided in a universally available format (thumb drives and DVDs are no longer universal). The preamble of the new eIFU regulation says, “To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates, those instructions should be available on the website of the manufacturer in an official language of the Union determined by the Member State in which the device is made available to the user or patient.” This does not mean you cannot deliver your eIFU on a private YouTube channel, for example.
Yes, there are professionals out there who prefer paper-based instructions or (it is true) might not have reliable internet access. While you may moan and groan about having to accommodate them, it is EU law to have paper IFUs with the exception of some devices. If a paper-based option is required, you are obligated to provide a paper version within seven calendar days of request at no cost. In cases where video or animation is not used, the eIFU may simply be a printed copy of the PDF you maintain online. Make sure to update your labeling SOP with this requirement.
Making your IFU available online is easy. Ensuring that it does not accidentally get removed or replaced is not. You will need to put procedures in place to ensure that your sales and marketing departments do not change the URL, delete old versions, or otherwise change the document. You should really think of the master IFU web page(s) as controlled documents, not just the IFU itself.
For devices without a defined expiration date, your IFU needs to be maintained for 15 years after the last device has been placed on the market. For devices with an expiration date, this changes to 10 years. You also need to have a system of indicating when changes have been made (change control) and a way to inform each user if the change was made for safety reasons (see Article 5(12)). Finally, all historical versions of the IFU must be made available on the website.
Europe has one of the strictest online privacy laws in the world, known simply as the GDPR (General Data Protection Regulation 2016/679). If you will be asking the user to provide their name and/or email, or your website has cookies enabled (most do), you will need to make sure you are following the GDPR. Ask your website administrator – they will know.
In reality, it is not all that common for professional users to request printed copies of an IFU that exists electronically. Most customers will go to the website, download a PDF, and print it themselves. So, is it really necessary for you to stock printed copies of your IFU? Maybe not. In these cases, a PDF would allow you to print it on demand and mail it to the customer within seven days if they request a copy and do not want you to email it to them.
If you are considering the switch to electronic IFUs and will pursue CE Marking under the MDR, you will want to be sure to address all points noted above. The best way to ensure compliance is to carefully follow the (EU) 2021/2226 eIFU regulation plus MDR Annex I, Chapter III and ISO 20417:2021. Your Notified Body will carefully verify and review your eIFU compliance during conformity assessment based on a specific sampling method.
There is so much more to learn about medical device labeling and EU MDR compliance. If you would like to expand your knowledge, consider our in-depth training on the EU Medical Device Regulation. Our team can also help ensure that your eIFU covers all required and specific elements found in EU Regulation 207/2012 and the EU MDR.
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