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Home > Medical Device made Easy Podcast > Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
Podcast: Medical Device made Easy Podcast
Episode:

Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
Category: Business
Duration: 00:00:00
Publish Date: 2025-07-24 00:18:57
Description:
Podcast 346 Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers monir el azzouzi easy medical device

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 turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU.

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