EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226.
We have summarized the requirements for electronic instructions for use for you.
1. Requirements for the use of electronic instructions for use
According to Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met:
- The device falls into a specific class:
- Implantable and active implantable medical devices and their accessories
- Fixed installed medical devices and their accessories
- Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use (e.g., ultrasound equipment)
- And: the devices and accessories are intended for exclusive use by professional users (exception: software!)
- And: a risk analysis has been carried out that covers the following:
- Users’ experiences with the device and with eIFUs
- Context of use (is a computer available?)
- Impact of the IFU being inaccessible (e.g., the Internet is not available)
- The website’s compatibility in terms of displaying the eIFU on different devices
- Potential emergency situations
- Protection against falsification of the IFU and management of different versions, if applicable
- Time for the user to obtain a paper version
- And: the instructions for use (IFU) can be made available in paper form within seven days
- And: the existence of an eIFU is indicated on the label
- And: the eIFU is available on the manufacturer’s website
- And: a “mini-instructions for use” is available for emergencies and installation (and also explains where to obtain a paper version).
2. eIFU for software even when used by laypersons
For software as defined by the MDR, the electronic form is also permitted even if the product is not used only by professionals. For medical software, an eIFU is allowed even when the product is used by lay persons. The electronic instructions for use must be provided through the software itself and not in paper form (Article 3(3) of Implementing Regulation (EU) 2021/2226).
3. Special case: IVDs and products without an intended medical purpose
Implementing Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic medical devices (IVDs). For them, the IVDR governs when manufacturers may deviate from the paper form:
“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.”
IVDR (Regulation 2017/746) Annex I, Chapter III, 20.1.f
Regulation 2021/2226 also does not apply to products without an intended medical purpose as defined by Annex XVI of the MDR.
4. New features introduced in Regulation 2021/2226
Implementing Regulation 2021/2226 has replaced the previous EU regulation 207/2021, which was previously also valid under the MDR. However, Regulation 207/2021 remains valid for devices placed on the market or put into service during the transitional period according to Article 120(3) of the MDR.
You can find out more about the MDR transitional periods in our article on transitional periods.
The most important changes introduced by the new Implementing Regulation 2021/2226 are:
a) Software
eIFUs can now be provided for software even if the software is used by lay persons.
b) Risk assessment
Two points have been added to the risk assessment according to Article 4:
(j) | assessment of the website’s compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions;
(k) | management of different versions of the instructions for use, where applicable in accordance with Article 5(8).
c) eIFU on the manufacturer’s website
The manufacturer’s obligation according to Article 5(12) when providing an eIFU is also worth noting:
“effective systems and procedures shall be in place to ensure that device users having downloaded instructions for use from the website can be informed in case of updates or corrective actions with regards to those instructions for use.”
If an eIFU is provided, it must be available on the manufacturer’s website (Article 5(11)).
(13) all issued historical electronic versions of the instructions for use shall be available on the website.
d) eIFU indication on device labels
According to Article 6(1), manufacturers must now clearly indicate in the labeling that the instructions for use for the device are supplied in electronic form instead of in paper form.
Symbol 5.4.3 from ISO 15223-1 or ISO 7000-1641 with the addition of “eIFU” and “Indicator” can be used to do this.
The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
The “mini instructions for use” explaining how to access the eIFU should now also contain the Basic UDI-DI or UDI-DI (Article 6(3)(b))
5. Conclusion
The introduction of electronic instructions for use is a great relief for a lot of users and will also provide a lot of benefits for medical device manufacturers as well. Manufacturers who want to provide instructions for use in electronic form should study the requirements of Implementing Regulation 2021/2226 carefully and take into account the possible risks associated with using electronic instructions for use.
Change history
- 2022-01-20: Amendments to Implementing Regulation (EU) 2021/2226 and guidance on IVD added.
