[article originally published on June 19, 2025, updated with the publication of Regulation (EU) 2025/1234]

Implementing Regulation (EU) 2021/2226, which regulates the electronic supply of instructions for use for medical devices, has been significantly amended by Regulation (EU) 2025/1234. This amendment responds to technological developments and feedback from healthcare professionals, who overwhelmingly prefer electronic instructions.

The amendment is based on a survey conducted by the European Commission from August to October 2024, which revealed a clear preference among healthcare professionals for electronic instructions for use.

Main changes concerning e-IFU

Extension of the scope

• Removal of the exclusion of products in Annex XVI: The third paragraph of Article 1 is deleted, allowing the inclusion of non-medical devices listed in Annex XVI of Regulation (EU) 2017/745.

Simplification of Requirements

• Deletion of Article 8: The requirement for a notified body to review the requirements for electronic instructions is deleted, eliminating redundancy with conformity assessment activities.
• Deletion of point (12) of Article 5: The requirement for user information systems for each update of the eIFU is deleted; it remains valid in the event of a safety issue.
• Deletion of paragraph (4) of Article 6: The restriction on the provision by electronic means of parts of the IFU intended for patients is deleted.

Substantial changes

• Article 2: Deletion of the term “medical” in the definition of professional users, extending the concept to devices not intended for medical use.
• Article 3: Reformulation allowing manufacturers to provide electronic instructions for all devices intended for professional users, with an obligation to maintain paper instructions for non-professional users, where applicable.
• Article 7: Deletion of point (f) of paragraph 2 concerning previous versions of instructions.

Significant additions

• New paragraph (3) of Article 7: Obligation for manufacturers to provide the web address of electronic instructions to the Eudamed UDI database as soon as registration of devices becomes mandatory.
• Article 2, point (3): New precise definition of “fixed devices” including criteria for installation and mobility.

Impact for Medical Device Manufacturers

Opportunities

• Expanded scope: Possibility to provide electronic instructions for all devices intended for professional users.
• Administrative simplification: Removal of certain redundant obligations.
• Digital integration: Direct connection to the Eudamed database for improved traceability.

New obligations

• System updates: Adaptation of processes to incorporate the new Eudamed requirements.
• User assessment: In-depth analysis to determine whether devices can be used by non-professionals.

Implementation Timeline

The amendment will enter into force twenty days after publication in the Official Journal of the European Union. Manufacturers must adapt their processes accordingly, particularly for integration with Eudamed in accordance with the deadlines set out in Article 123(3) of Regulation (EU) 2017/745.