No one can undermine the importance of Instructions for Use (IFUs) attached to a medical device. These instructions are very important to help patients and users of the medical device understand the correct way of using that device and achieving the outcomes intended. However, with rapidly changing global technological dynamics, medical device manufacturers look forward to incorporating their IFUs and labels electronically via their websites, device screen displays, or other secure portals. This practice is also known as ‘eLabeling.’
What are the Benefits of eLabeling a Medical Device?
Medical device eLabeling has several benefits, such as:
- Less consumption of paper
- Overall cost reduction
- Updates and improvements can be made quicker in IFUs
- Overall lesser probability of having outdated IFUs
- The use of videos and animations can make device operation easier to understand
eLabeling Regulations in Europe
Under Regulation 207, eIFUs (electronic Instructions for Use) have been permitted in the EU since March 2013. In September 2021, this Regulation saw an update (in the form of a draft). These drafted updates aimed to harmonize Regulation 207 with EU MDR’s Chapter III and its other sections.
Regulations from the draft are listed as follows:
- According to Article No. 3 of the EU’s IFU regulations, eIFU can only be used for the following devices:
- Those devices and accessories that are meant to be used exclusively by the professionals
- Software (where there is no requirement for a paper option)
- Devices having a built-in screen display
- Medical devices with fixed screens installed
- Implantable devices
Manufacturers must also remember that EU MDR’s Annex I, Chapter III, 23.1 (d) states that Class I and Class IIa medical devices do not need IFUs if they can be used safely without instructions.
Important Considerations for Manufacturers while Switching to an eIFU
Except for software, many medical device manufacturers prefer enclosing their devices’ IFUs in the form of a PDF. For such manufacturers, staying compliant with the MDR and eIFU regulations is important. In this regard, they should consider the following:
Risk Assessment
According to Article 5 of the draft regulation, an eIFU must maintain or enhance its safety against a regular paper IFU. Manufacturers can ensure this by performing a risk assessment. For example, consider a situation where medical practitioners use a medical device in rural areas with an unstable internet connection. In this scenario, the manufacturer must consider any additional risks that might be present. After identifying those risks, the manufacturer can update its risk management procedures and forms accordingly.
Packaging of Products
As per Article 6, eIFU’s location must be indicated on each unit’s packaging. In the case of a fixed device, this location must be present on the device itself. It is obvious that the manufacturers cannot only display their devices’ IFUs in PDF forms on their websites while assuming that professionals will look there in case of any problem. Therefore, under Article 6, manufacturers must specify on their products’ packaging about the IFU being in electronic format and where it can be found.
Other than the software and devices having screens, IFU can be placed on the website, while its location can be relayed through a URL or a QR code. If manufacturers prefer QR codes, they must ensure to document the pros and cons of using QR codes in their risk assessment and update the labeling work instruction as per needs.
Augmenting User Access
Manufacturers should also ensure that the user access to their medical devices is precise and contains accurate real-time data. They should also ensure having a solution for delivering the information in the preferred language of their users.
Delivery Method
For devices such as SaMDs (Software as a Medical Device) or those with larger display screens, the method of delivering IFUs can be the devices themselves. However, for IFUs and labels of other devices, the delivery method will be via manufacturers’ websites. In this regard, manufacturers must ensure fulfilling an important requirement, i.e., providing IFUs in a universally acceptable format.
In words of the preamble of the new eIFU regulations,
‘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.’
Paper Version of IFU
Many practitioners and professionals prefer having IFUs in paper format. To accommodate their needs, the EU law directs manufacturers to present practitioners and professionals with paper-based IFUs (except for some devices). Manufacturers should provide these paper IFUs within seven calendar days upon request without asking for additional costs. In places without a video or animation, the PDF copy put on the manufacturers’ website can be used as an eIFU. With this requirement, however, manufacturers must ensure to update their labeling SOPs.
Online Security for eIFUS
Although many manufacturers can easily place their eIFUs online, it is their responsibility to ensure that it does not get replaced or removed. They should develop procedures that refrain their sales and marketing departments from changing the eIFU’s URL, deleting its previous versions, or making any changes to the document.
Procedures for Archives
Devices without a defined expiration date should maintain their IFUs for 15 years after the device’s last placement on the market. But this period is reduced to 10 years for devices with an expiration date. Manufacturers should also
- Have a system indicating any changes being made (change control), and
- A way to inform users, if the changes were made to address any safety concerns
Manufacturers’ websites should also contain all the previous versions of IFUs.
Privacy Policy
The European online privacy laws are known as General Data Protection Regulation 2016/679. Thus, manufacturers asking users for their names and email address or collecting cookies through their websites must ensure compliance with the EU GDPR requirements.
Satisfying the Notified Bodies
Notified Bodies are tasked with ensuring medical device manufacturers’ compliance with EU MDR requirements. Thus, those manufacturers who want to switch to eIFUs and pursue CE marketing must follow all the above points. To do so, they can fulfill the requirements given in the draft (as mentioned above). They should also comply with the requirements of
- MDR Annex I, and
- ISO 20417:2021
Based on the sampling method, Notified Bodies will verify and review the manufacturers’ eIFU compliance while performing the conformity assessment.
Alysidia can help you with Compliant eIFU and eLabeling Solutions
If you are a medical device manufacturer wanting to turn to eIFU, consider experts at Alysidia have developed solutions for you. We have highly qualified professionals (who are well-versed with the requirements of EU MDR) and expert software developers who worked together to produce compliant solutions for you. Let us know your requirements and how we can help you comply with eLabeling and eIFU requirements of EU MDR.
