Updated Regulation on Electronic Instructions for Use: What Medical Device Manufacturers Need to Know

Key change: electronic IFUs now allowed for all professional-use devices

Previously, eIFUs were permitted only for specific categories of medical devices, such as implantables or fixed installations. Under the amendment, manufacturers may now provide electronic instructions for all medical devices and accessories intended for professional users under Regulation (EU) 2017/745 (MDR).
Devices without an intended medical purpose (listed in Annex XVI MDR) are also included, provided they are for professional use.

However, if it is foreseeable that a device may also be used by lay persons, such as patients, the instructions intended for them must still be supplied in paper form.

Simplified compliance and integration with EUDAMED

Once EUDAMED registration becomes mandatory, manufacturers must provide the internet address (URL) where their eIFUs are accessible within the UDI database.
This ensures traceability, transparency, and consistent access for authorities and users alike.
The update also clarifies several provisions and removes redundancies, simplifying the regulatory text and reducing administrative burden.

Transition and repeal

Commission Regulation (EU) No 207/2012 will now remain applicable for legacy devices placed on the market under MDR’s transitional provisions until 31 December 2028.
After that, only Regulation (EU) 2021/2226 (as amended) will apply to all professional-use medical devices.

What this means for manufacturers

For manufacturers, this amendment reflects a clear EU move toward digitalization and sustainability, streamlining documentation processes while maintaining safety and accessibility.
Most important updates:

• eIFUs are now broadly permitted for all professional-use devices.
• Paper instructions remain mandatory for lay users.
• Integration with EUDAMED ensures better traceability.
• Transitional rules extend until end of 2028.

Medical device companies should review their documentation processes, ensure eIFU systems meet data accessibility and security requirements, and prepare for the EUDAMED integration phase.

Update your eIFU compliance under MDR

Our regulatory experts help align your documentation, technical files, and EUDAMED registration, ensuring your products stay compliant in an increasingly digital regulatory landscape.

Contact our MDR specialists

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