The European Commission Survey on Electronic Instructions For Use (eIFUs) for Medical Devices

This blog was originally posted on 16th September, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY DENISE MCDERMOTT, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Survey on Electronic Instructions For Use (eIFUs) for Medical Devices – Overview

Implementing EU Regulation 2021/2226, on laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices, allows the information in the instructions for use for certain medical devices, to  be provided by manufacturers in electronic form. As per Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper for certain devices including;

• 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

Such eIFUs are allowed in cases where the devices and accessories are only intended for use by professional users, except in the case of software covered by Regulation (EU) 2017/745, where manufacturers may provide an eIFU by means of the software itself. Moreover, manufacturers must provide a documented risk assessment which covers elements including knowledge and experience of the intended users regarding the use of the device and user needs, and characteristics of the environment in which the device will be used, among others. Additional conditions apply, including that the instructions for use (IFU) can be made available in paper form, at the latest within 7 calendar days, and that manufacturers have indicated on the label that the instructions for use of the device are supplied in electronic form instead of in paper form. 

In February 2024 MedTech Europe published a statement on the use of electronic instructions for use in the medical sector. The statement argued for an expansion to the scope of Regulation 2021/2226, allowing all professional-use medical devices to be accompanied by an eIFU.

The European Commission has now published a survey to gain feedback on the expansion of the use of an eIFU to all professional-use medical devices. The survey opened on 1st August 2024 and targets healthcare professionals and those working in healthcare institutions. This survey is available in all EU languages and is estimated to take no more than 5 minutes. It can be accessed here.

This survey will close on 11 October 2024.

References

1. European Commission survey
2. EU Regulation 2021/2226
3. EU Regulation 2017/745
4. MedTech Europe statement on the use of electronic instructions for use in the medical sector

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