On 26 June 2025, the European Commission Implementing Regulation (EU) 2025/1234 formally expanded the use of electronic instructions for use (eIFUs) across a broader set of medical devices. This marks a significant shift toward digital documentation and greater manufacturing flexibility across the European Union.
Key Changes from the EU eIFU Update
1. eIFU use extended to professional-use devices
Manufacturers may now provide electronic IFUs for devices in scope of the regulation intended for use by professionals. This significantly expands the eligible product categories for eIFUs under EU MDR 2017/745.
2. Paper IFUs still required for layperson-use devices
Devices that may be used by patients or the general public must still include a printed IFU, preserving accessibility and compliance for consumer products.
3. Implications for sterilization planning
Even though IFUs are typically located outside the sterile barrier, this change improves flexibility when selecting a sterilization technology. Some products with large paper IFUs are difficult to process or have extra complexity when using sterilization technologies such as VHP that is incompatible with common IFU papers or electron beam (E-Beam) that is challenged by large dense items in or near the product during treatment. Removal of the large IFU typically used for products sold in the EU makes it much easier to enjoy the advantages of these technologies such as fast turn time and good materials compatibility.
What Happens Next?
The regulation is now in effect, and manufacturers selling into the EU should:
- Update plans for new product development to leverage eIFU where eligible
- Consider sterilization technologies such as VHP or E-Beam that might now be possible or easier to do with an eIFU that were not practical previously.
This is a strategic opportunity to reduce packaging costs, streamline documentation, and support sustainability goals while remaining compliant with MDR.
Supporting Your Transition
Whether you’re evaluating eIFU eligibility or adapting sterilization plans to support digital instructions, NextBeam can help you transition confidently with:
- Device-level compatibility assessments
- Sterilization planning support across modalities
- Regulatory navigation and documentation review
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