Commission Implementing Regulation (EU) 2025/1234 significantly broadens the possibilities for electronic instructions for use (eIFU) for medical devices.
Key Changes:
- Expanded Application: Manufacturers can provide instructions for use for medical devices and accessories in electronic form instead of paper form when used by professional users - no longer limited to implantable, fixed-installed devices and software only.
- Streamlined Review Process: The separate requirement for Notified Body review of eIFU obligations has been removed - this is now integrated into general conformity assessment activities.
Still Applies:
- Paper Requirements for Lay Users: When professional medical devices may foreseeably be used by lay persons, instructions for lay users must still be provided in paper form.
- Flexible Archiving: Historical versions must be available during retention periods or provided upon request.
Requirements for Manufacturers:
Manufacturers must conduct documented risk management demonstrating that eIFU maintains safety at least at the level of paper instructions. Labels must clearly indicate that instructions are provided electronically, including access details and contact information for requesting paper versions. Integration into the Eudamed database will become mandatory once operational.
With many years of expertise in risk management, usability, and labeling, NSF supports manufacturers in successfully transitioning to eIFU while ensuring compliance is maintained.
