“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.”
This direct IVDR quotation provides the rule that needs to be followed in case of IVDs. However, when it comes to medical devices regulated by the MDR, the rules get more complicated. It is the goal of this article to shed some light on this issue.
Key elements of Regulation 2021/2226
Implementing Regulation 2021/2226 is a legal document published by the European Commission (EC). It regulates the usage of electronic instructions for use of MDs and sets all conditions that must be met. Those conditions are strict and only small percentage of MDs can have their IFUs in electronic form.
When it comes to electronic instructions for use (eIFU) the biggest issue is the small pool of MD manufacturers, that can actually choose to use it. Only 4 categories of MDs can have their IFU in electronic form. It is implantable and active implantable MDs and their accessories as defined in Art. 2(4) and (5) of MDR or fixed installed MDs and their accessories as defined in Art. 2(3) of IFUR or MDs and their accessories covered by MDR and fitted with a built-in system visually displaying the IFUs. The last category is software governed by the MDR.
The IFUR sets number of other conditions. For example, the manufacturer must conduct a demanding risk assessment, they must secure efficient accessibility of the electronic form, but also of paper form upon request and they of course need to ensure data security. Another important condition is that the MD must be intended for professional use. However, this last condition not apply to software MDs and there IFUs can be in electronic form even in cases of non-professional use.
(Dis)advantages of eIFU
Significant advantage of eIFU is its practicality. It saves space and is easier to access for hospitals and other health institutions. MedTech Europe conducted a survey amongst healthcare professionals (HCP) and its results support the extension of eIFU for all professional use of MDs. Main supporting arguments are that 99% of HCP have internet access in their place of work, 90% of hospital admin staff and 88% of HCP prefers eIFU.
One of EU’s crucial goals is implementing environmental policies and benefits of eIFU can be seen in this area as well. According to “Joint statement supporting the expansion of the use of eIFU in the medical devices sector”, drafted by representatives of MDs industry and healtcare providers, the transition to eIFU could save several thousands tons of paper each year. Not only it would reduce costs for companies, but this measure would significantly reduce the paper waste. In addition to all these benefits, expansion in use of eIFU seems to be the international trend. Countries like the USA, Japan or South Korea have legislation that supports sole use of eIFU in medical devices used by health care professionals. The discussion is now held in EU as well and might be one of the 2024 priorities in MD industry.
With all these benefits in mind, it is still important to be aware of the cybersecurity risk that comes with any electronic instrument. In medical industry it is especially important to take appropriate measures in order to ensure cyber stability and security.
Author: Gabriela Charvátová