EU Regulation 2017/745 (MDR) specifies the general requirements for instructions for use (IFU for short). The Implementing Regulation (EU) 2021/2226 regulates whether it can also be available in electronic format (eIFU).

We have summarized the requirements of the electronic operating instructions for you.

1. Requirements for using the electronic operating instructions

According to Implementing Regulation (EU) 2021/2226, instructions for use may also be available in electronic rather than paper format (eIFU) if certain requirements are met:

• The product falls into a specific device class:
  • Active implantable and implantable medical devices and accessories
  • Permanently installed medical devices and accessories (e.g. MRI)
  • Medical devices and accessories in which an instructions for use display system is integrated (e.g. ultrasound machine)
• e: The devices and accessories are exclusively for professionals (exception: software!).
• e: A risk analysis is available which examines:
  • User experience with the device and eIFU
  • Context of use (is a computer available?)
  • Consequences if you cannot access the IFU (e.g. internet is unavailable)
  • Compatibility of the eIFU website with various devices
  • Possible emergency situations
  • Protection against IFU falsification and, if necessary, versioning
  • Period of time until the user can receive a paper version
• e: The Instructions for Use (IFU) can be made available in paper format in less than seven days.
• e: The eIFU is identified on the label.
• e: The eIFU is available on the manufacturer’s website.
• e: A “mini instruction manual” is available for emergencies and installation (in which you can also see where to find the paper version).

2. eIFU for the software even if used by non-experts

For software under the MDR, the electronic form is permitted even if the product is not used exclusively by professionals. For medical software, eIFU is permitted even when the product is used by laypeople. Electronic instructions for use must be provided using the software itself and not in paper format (Article 3(3) of Implementing Regulation (EU) 2021/2226).

3. Special case of IVD and products without medical purpose

Implementing Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic devices (IVDs). Instead, the IVDR regulates when manufacturers can deviate from paper form:

“If the product is intended for professional use only, instructions for use may be provided to the user in a form other than paper (e.g. in electronic format), unless the product is intended for testing at the point of care.”

IVDR (VO 2017/746) Anhang I, Capitol III, 20.1.f

Furthermore, Regulation 2021/2226 does not apply to products without medical destination pursuant to Annex XVI of the MDR.

4. Innovations through Regulation 2021/2226

Implementing Regulation 2021/2226 replaced the old EU Regulation 207/2012, previously also valid pursuant to the MDR. However, Regulation 207/2012 remains valid for products placed on the market or put into service during the transitional period referred to in Article 120(3) of the MDR.

The most important innovations brought by the new Implementing Regulation 2021/2226:

a) Software

The eIFU for software now it is possible even if the software is used by non-experts.

b) Risk assessment

Al Risk assessment pursuant to art. 4, two points have been added:

j) Evaluate the compatibility of the website in viewing the electronic user manual on different devices that may be used to view this user manual
k) Where applicable, management of different versions of the instructions for use in accordance with Article 5(8).

c) eIFU on the manufacturer’s website

It is also worth noting the manufacturer’s obligation to provide an eIFU under Article 5 (12):

Effective systems and procedures are in place to ensure that users of the products can be informed of any updates or corrective actions relating to the products after downloading the instructions for use from the website.

If an eIFU is made available, it must be available on the manufacturer’s website (Article 5(11)).

(13) All historical published electronic versions of the instructions for use are available on the website

d) eIFU in product labeling

According to Article 6(1), manufacturers must now clearly indicate on the label that instructions for use of the product are provided in electronic rather than paper format.

For this purpose you can use symbol 5.4.3 of ISO 15223-1 or ISO 7000-1641 with the addition “eIFU” and “Indicator”:

The eIFU indicator may be the URL of the manufacturer’s website or some other appropriate indication that the instructions for use are available in electronic format.

The “Mini Instructions for Use”, which explains how to enable access to the eIFU, should now also contain the UDI-DI or the Basic UDI-DI (Article 6(3)(b).

5. Relevance of the regulation even without eIFU

Implementing Regulation (EU) 2021/2226 is only not relevant if manufacturers use a pure eIFU. Annex I, Article 23.1 of the MDR states:

This information can and will appear on the product itself, on the packaging or in the instructions for use, if from the manufacturer via a website has – provided there and updated […]

This means all manufacturers duty upload your IfU to your website (or relevant content). This is precisely where article 9 of Regulation 2021/2226 comes into play:

1. In addition to the MDR, manufacturers are required to upload the exact equivalent of the paper format of the instructions for use.
2. This refers only to the instructions for use, not to the labels. The MDR does not require these to be published online, but only their content, which is also covered in the instructions for use.
3. According to article 7 of Regulation 2021/2226, producers must:
   • Protect your website from unauthorized access and modifications
   • Ensure data protection
   • Ensure access to the website for the life of the product
   • Archive all old versions of the uploaded operating instructions

6. Conclusion

Electronic operating instructions are a great relief for many users and also bring numerous benefits to medical device manufacturers. However, manufacturers wishing to make their instructions for use available in electronic format should carefully study the requirements of Implementing Regulation 2021/2226 and take into account the possible risks posed by electronic instructions for use.

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