EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

Key Changes in the Amended Regulation

The draft Commission Implementing Regulation introduces several pivotal changes to the existing framework:

• Expanded Scope of eIFU: The most significant change is the extension of eIFU applicability to all medical devices and their accessories intended for professional users, including those under transitional provisions of Regulation (EU) 2017/745. This broadens the previous limitation to certain devices.
• Inclusion of Devices Without Intended Medical Purpose: The amended regulation now explicitly includes devices without an intended medical purpose, as listed in Annex XVI to Regulation (EU) 2017/745, provided they are for professional use. This ensures a consistent approach across a wider spectrum of products.
• Clarification for Lay Persons: For devices intended for professional use but also foreseeably used by lay persons (e.g., patients), manufacturers are still required to provide paper-based IFU for lay users. This maintains a crucial safety net for non-professionals.
• Eudamed UDI Database Integration: Manufacturers will be required to provide the internet address where eIFU are accessible to Eudamed's Unique Device Identifier (UDI) database. This becomes mandatory from the date the UDI database registration applies, streamlining access to digital IFU.
• Streamlined Requirements: Some existing requirements in Implementing Regulation (EU) 2021/2226 have been clarified or deleted to remove uncertainties and redundancies. For instance, separate requirements for information supplied by the manufacturer are removed as they are already covered by conformity assessment activities under Regulation (EU) 2017/745.

Implications for the Medical Device Industry

These amendments signify a move towards greater digitalization in the medical device sector. For manufacturers, this means a potential reduction in printing and distribution costs associated with paper IFU, alongside an increased emphasis on robust digital infrastructure for hosting and managing eIFU. The integration with the Eudamed UDI database underscores the growing importance of centralized digital information systems in EU medical device regulation. Companies will need to ensure their systems are compliant with the new requirements for providing internet addresses for eIFU.

Conclusion

The European Commission's latest draft amendment to Implementing Regulation (EU) 2021/2226 marks a significant step in modernizing the provision of Instructions for Use for medical devices. By expanding the scope of eIFU and integrating with the Eudamed UDI database, the regulation aims to enhance efficiency, reduce environmental impact, and improve accessibility of information for healthcare professionals. Medical device manufacturers should review these updates carefully to ensure timely compliance and leverage the benefits of digital transformation.

Reference

Source: 2. draft act_amendment eIFU Regulation_Committee MD_6.6.2025 (June 2025).