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SubscribeThe European Commission adopted the Implementing Regulation (EU) 2025/1234 ("Regulation 2025/1234"), on June 25, 2025, amending the 2021 framework on electronic instructions for use ("e-IFU") of medical devices. The new text reshapes the reach of the e-IFU regime, clarifies grey areas that have troubled manufacturers since 2021 and ties compliance more tightly to the Unique Device Identifier (UDI) module of Eudamed.
Broadened scope: "all devices for professional use"
The 2021 Regulation limited e-IFU to a closed list of products (active implantables, fixed installed devices, etc.). Regulation 2025/1234 deletes that limitation, extending the e-IFU option to all devices and accessories intended for professional users, including:
- Class I to III medical devices covered by Regulation (EU) 2017/745 of 5 April 2017, on medical devices ("MDR");
- Legacy devices under the MDR’s transitional Article 120; and
- Devices without an intended medical purpose listed in Annex XVI (e.g., aesthetic dermal fillers, coloured contact lenses).
Manufacturers across the spectrum—orthopaedic implants, hospital software, surgical gloves—may now migrate fully to e-IFUs for professional users, enabling cost savings and real-time update capabilities. However, if it is "reasonably foreseeable" that lay persons will handle a device intended for professional settings, the paper IFU becomes compulsory for that lay audience.
Eudamed alignment: publication of the e-IFU web address
Once Eudamed device registration becomes mandatory, manufacturers must upload the URL of the e-IFU in the UDI database. This creates a single EU-wide reference point for healthcare professionals, inspectors, and notified bodies.
Applicability
The Regulation has been applicable since mid-July 2025. However, the Eudamed URL obligation "switches on" once UDI registration becomes mandatory—currently linked to the long-awaited full deployment of Eudamed.
Conclusion
Regulation 2025/1234 marks the EU’s definitive push toward digital documentation in the medical-device arena—balanced by patient-safety guardrails and stronger database connectivity. Companies that embrace the transition early stand to gain operational efficiencies and smoother market access, while those that overlook the enlarged scope or Eudamed link risk non-compliance penalties and supply disruptions.
This measure, in our view, constitutes yet another step towards the simplification of the regulatory framework applicable to medical devices, and comes at a time when the revision of the Medical Devices Regulation is under discussion. It is essential for stakeholders in the sector to closely monitor these developments, ensuring timely adaptation of internal procedures and digital systems to remain compliant and to take advantage of the opportunities created by this new framework.
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