European Commission launches consultation on electronic instructions for use
Regulatory News | 24 February 2025 |
The European Commission is asking for stakeholder input on a plan to allow electronic medical device instructions for use (eIFU) be provided to healthcare providers for all devices, not just high-risk products. The consultation was released on 21 February and stakeholders have a month to provide feedback.
A survey conducted by the Commission last year examined the preference for replacing paper-based instructions for use with electronic instructions. The results “show a clear preference, among healthcare professionals, for receiving instructions in electronic form rather than in paper. Providing instructions for use in electronic form helps the health sector deliver better and faster solutions,” the Commission said.
The Commission proposed allowing manufacturers of medical devices and their accessories to provide instructions for use in electronic form instead of in paper form for professional users in compliance with Regulation (EU) 2017/745.
The proposal further states that once registering devices in the European database for medical devices (Eudamed) becomes mandatory, manufacturers would be required to provide the Uniform Resource Locator (URL) for the eIFU. The Eudamed database is slated to become mandatory for medical devices allowed in Europe starting in the first quarter of 2026.
In December 2021, the Commission issued a regulation on when medical device instructions for use (IFUs) can be provided in electronic form. The guidelines permit eIFUs for high-risk devices, such as implantable and active implantable medical devices and their accessories. However, the provision does not apply to other types of devices used by healthcare professionals.
The Commission’s proposal aligns with the European medtech industry’s plans to promote more environmentally and financially friendly solutions to boost competitiveness. (RELATED: EC outlines rules for electronic IFU for med devices, Regulatory Focus 16 December 2021)
Last year, MedTech Europe, the European medtech lobby group, proposed ten actionsto clear the barriers and cited the rules on eIFUs as one area needing reform. (RELATED: Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025, Regulatory Focus 14 November 2024)
The Commission has already received feedback from industry members who support the change from paper to electronic IFUs.
Raffin Medical in France wrote that “in an era where everything is digitalised, it is important to authorise digital UFIs for 2 reasons: — when an IFU is present in a cardboard, the end user who is the nurse does not have access to it, since the carton has remained in the storage unit, it would well be possible to accept the IFU via a QR code on the product label. All nurses have their phones in the blocks – it is the waste of unused and discarded paper, which has a negative impact on the planet.”
The deadline for commenting is 21 March. The Commission intends to adopt the regulation in the second quarter of 2025.
Consultation
A survey conducted by the Commission last year examined the preference for replacing paper-based instructions for use with electronic instructions. The results “show a clear preference, among healthcare professionals, for receiving instructions in electronic form rather than in paper. Providing instructions for use in electronic form helps the health sector deliver better and faster solutions,” the Commission said.
The Commission proposed allowing manufacturers of medical devices and their accessories to provide instructions for use in electronic form instead of in paper form for professional users in compliance with Regulation (EU) 2017/745.
The proposal further states that once registering devices in the European database for medical devices (Eudamed) becomes mandatory, manufacturers would be required to provide the Uniform Resource Locator (URL) for the eIFU. The Eudamed database is slated to become mandatory for medical devices allowed in Europe starting in the first quarter of 2026.
In December 2021, the Commission issued a regulation on when medical device instructions for use (IFUs) can be provided in electronic form. The guidelines permit eIFUs for high-risk devices, such as implantable and active implantable medical devices and their accessories. However, the provision does not apply to other types of devices used by healthcare professionals.
The Commission’s proposal aligns with the European medtech industry’s plans to promote more environmentally and financially friendly solutions to boost competitiveness. (RELATED: EC outlines rules for electronic IFU for med devices, Regulatory Focus 16 December 2021)
Last year, MedTech Europe, the European medtech lobby group, proposed ten actionsto clear the barriers and cited the rules on eIFUs as one area needing reform. (RELATED: Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025, Regulatory Focus 14 November 2024)
The Commission has already received feedback from industry members who support the change from paper to electronic IFUs.
Raffin Medical in France wrote that “in an era where everything is digitalised, it is important to authorise digital UFIs for 2 reasons: — when an IFU is present in a cardboard, the end user who is the nurse does not have access to it, since the carton has remained in the storage unit, it would well be possible to accept the IFU via a QR code on the product label. All nurses have their phones in the blocks – it is the waste of unused and discarded paper, which has a negative impact on the planet.”
The deadline for commenting is 21 March. The Commission intends to adopt the regulation in the second quarter of 2025.
Consultation
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