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Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices
On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI.
This shift marks a…
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