The new regulation significantly expands the scope of electronic instructions for use (eIFU) to include almost all medical devices intended for professional use, including products with no medical purpose listed in Annex XVI of the MDR.
Expanded scope of application
On 16 July 2025, Commission Implementing Regulation (EU) 2025/1234 will enter into force, amending the existing eIFU Regulation (EU) 2021/2226.
The new regulation significantly expands the scope of electronic instructions for use (eIFU) to include almost all medical devices intended for professional use, including products with no medical purpose listed in Annex XVI of the Medical Device Regulation (EU) 2017/745 ("MDR").
The amended regulation now allows eIFU for all types of medical devices and accessories intended for professional users. However, a paper version must still be made available free of charge upon request.
Further, the regulation now also applies to so-called "legacy devices" under MDR Art. 120 transitional provisions, where the use of eIFU remains optional.
Key changes introduced
Several previous requirements have been removed or streamlined, with the intention to make it easier to implement eIFU:
- The obligation to publish all historical versions of the IFU online has been removed – obsolete versions must now only be made available upon request.
- The requirement to notify users of updates has been removed.
- Article 7(3) now refers to an "internet address" instead of the previously stricter requirement for a "stable and directly accessible" URL.
- The regulation also specifies that if a device intended for professional use can reasonably be expected to be used by lay persons (e.g. patients), a paper IFU must still be provided.
Further, once registration in the EUDAMED UDI database becomes mandatory, manufacturers must provide the database with a link to the eIFU.
Compliance obligations remain
Although the regulation provides greater flexibility, the use of eIFU still entails certain requirements:
- A risk assessment must be conducted, including the user's access to technology and any need for paper in emergencies.
- The eIFU system must be secure, accessible and kept up to date.
- Paper versions must be provided free of charge within seven days of a request.
- The eIFU solution does not require prior approval but must be addressed within the manufacturer's conformity assessment procedure under the MDR and may be subject to review by a notified body as part of the process.
Who should act – and how?
Manufacturers already using eIFU may now expand their use to a broader range of devices, including "legacy devices" and devices without a medical purpose intended for professional use.
Manufacturers not yet using eIFU may find this a good opportunity to evaluate its potential advantages. Implementing eIFU requires investment in digital infrastructure and integration into the quality management system, including conducting a documented risk assessment and ensuring compliance with requirements for accessibility, security, and version control.
While certain administrative obligations have been streamlined – such as the removal of the obligation to notify users of updates and the relaxation of historical version publication – the core legal obligations under the eIFU framework remain applicable.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
