*eIFU news! Amendment in pipeline * June 2025! The committee has exchange views and accepted the vote on the draft Commission Implementing Regulation that will broaden the scope and streamline the requirements for eIFU in the European Union. KEY CHANGES: ♦️ Broader Scope: Now also covers devices without an intended medical purpose. This extension ensures that more devices can benefit from electronic instructions, making the healthcare sector more efficient and eco-friendly. ♦️ Lay Person Safety: For safety reasons, eIFUs are still not permitted for lay persons. If a device is intended for use by both, professionals and lay persons, manufacturers must provide physical instructions for lay persons. ♦️ Streamlined Requirements: Certain redundant requirements are clarified or removed to enhance compliance and reduce administrative burdens. For example, manufacturers will provide the internet address for electronic instructions in the Eudamed’s Unique Device Identifier (UDI) database once registration becomes mandatory.