Electronic IFU Medical Device: EU MDR Digital Proposal
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Is the era of paper-based instructions coming to an end? The European Commission has launched a public consultation to update the regulation on electronic Instructions for Use (e-IFU). If adopted, all medical devices intended for healthcare professionals could use digital-only IFUs, eliminating the current limitations.
This proposal marks a major step towards digitalization in the medical device industry, offering clear benefits in terms of efficiency, sustainability, and regulatory compliance.
Which Devices Could Use e-IFUs?
Currently, e-IFUs are only allowed for specific categories of devices, such as:
- Implantable devices
- Devices with an integrated display for IFU visualization
- Fixed medical equipment
With the new proposal, all medical devices used by healthcare professionals could rely exclusively on electronic instructions, removing the requirement for paper copies (unless requested by the user).
Benefits of e-IFUs
- Immediate access & real-time updates
Healthcare professionals can access the latest IFU versions anytime, ensuring they always have the most up-to-date safety information. - Lower costs for manufacturers
Switching to digital IFUs reduces printing, logistics, and distribution costs. - Environmental impact
Less paper means a more sustainable approach, aligning with the EU’s green policies.
Challenges and Considerations
❌ Not all professionals are ready for full digital adoption
Some healthcare professionals still prefer paper IFUs for quick reference.
❌ Manufacturers must conduct risk assessments
Before switching to e-IFUs, manufacturers need to demonstrate that digital IFUs maintain or improve safety standards.
❌ Mandatory registration in EUDAMED
Manufacturers will need to register the official URL where e-IFUs are hosted in the EU’s EUDAMED database.
How to Participate in the Public Consultation?
- The European Commission has opened the consultation until March 21, 2025.
- Manufacturers, healthcare professionals, and other stakeholders can submit feedback here to help shape the final regulation.
Want to stay ahead of regulatory changes? We break down everything you need to know about the e-IFU proposal and how it could impact your regulatory strategy.
