eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health and digital medical devices.
We have been extensively talking about labelling in QualityMedDev website; in fact we have been discussing about ISO 15223:2021 and ISO 20417, both standards are currently the main reference for labelling requirements. Moreover we spoke about FDA requirements for labelling and UDI requirements based on the EU MDR and IVDR.
Instructions for Use (IFU) for medical devices have traditionally been paper-based. However, with the advent of electronic technologies, the possibility of digitising IFUs for medical and in vitro diagnostic (IVD) devices is nowadays accepted by regulatory agencies and notified bodies.
In this article, we are going to discuss about the requirements for eIFU mainly for the EU market, based on the Commission Implementing Regulation (EU) 2021/2226.
eIFU and EU MDR Requirements
Requirements for electronic instructions for use (eIFU) are reported in the Annex I, Chapter III, point 23 of the regulation.
Before talking in details about the requirements for eIFU, let’s have a look to the definition of Instructions for Use, as defined in article 2 of the Regulation:
‘instructions for use’ means the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken.
At the same time, instructions for use in electronic form (eIFU) means:
‘instructions for use in electronic form’ means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through a software or a website.
First of all it is important to remind that Commission Implementing Regulation (EU) 2021/2226 on eIFU does not apply to the devices listed in Annex XVI (thus devices without an intended medical purpose).
Regulation (EU) 2021/2226: Main Requirements
This regulation established that it is possible to provide information for use in electronic form rather than in paper form for the following devices:
- Implantable and active implantable medical devices and their accessories
- fixed installed medical devices and their accessories
- medical device (and accessories) fitted with a built-in system visually displaying the instructions for use.
There are basically two conditions under which it is possible to provide instructions for use in electronic form:
a) the devices and accessories are intended for exclusive use by professional users
b) the use by other persons is not reasonably foreseeable.
For software covered by Regulation (EU) 2017/745, manufacturers may provide instructions for use in electronic form by means of the software itself instead of in paper form.
At which conditions it is possible to provide eIFU?
Article 5 of the Commission Implementing Regulation (EU) 2021/2226 defines the list of conditions and requirements that the manufacturer must respect in order to provide Information for use in electronic form. We are not going into the whole list of requirements, we are just going to discuss few points.
One of the most important concept is that risk assessment shall evaluate from risk standpoint the fact that IFU are provided electronically and the risk associated shall be acceptable.
Moreover manufacturer shall have a system to provide IFU in paper form if it is requested, ad no additional cos
Another requirement is that the manufacturers shall provide, in their catalogue or other appropriate device information support, information on software and hardware requirements needed to display the instructions for use.
One last requirement it is important to mention is that manufacturers shall have a system in place to clearly indicate when the eIFU have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons.
There are more requirements that are all mention in the Article 5 of the Regulation (EU) 2021/2226; here in this section we have just been discussing the most important ones.
Additional Requirements for eIFU
Some additional requirements related to the use of electronic IFU are reported in Article 6 of the Commission Implementing Regulation (EU) 2021/2226.
First of all, it is necessary to indicate in the labelling that the instructions for use are provided in electronic form. This shall be indicated in the device packaging and, in case of fix devices, it shall be indicated on the device itself.
Moreover, it is ,mandatory to provide information on how to access information for use in electronic form. Specifically, this information shall include:
a) Any information needed to view the instructions for use;
b) the Basic UDI-DI and/or the UDI-DI of the device;
c) relevant manufacturer contact details;
d) where and how instructions for use in paper form can be requested and within which time they shall be obtained at no additional cost.
eIFU provided through website
It is possible to provide electronic information for use through specific website, typically the website of the manufacturer. The Commission Implementing Regulation (EU) 2021/2226 defines specific requirements in case the manufacturer wants to provide eIFU through thee web. Specifically, these requirements are:
a) the instructions for use shall be provided in a commonly used format that can be read with freely available software;
b) the website shall be protected against unauthorised access and tampering of content;
c) the website shall be provided in such a way that the server downtime and display errors are reduced as far as possible;
d) the website shall be compliant with the requirements of General Data Protection Regulation (EU) 2016/679;
e) the internet address shall be stable and directly accessible during the retention time of the eIFU.
f) all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website.
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