Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU) in the medical devices sector

Brussels, 2 February 2024 – Per the Medical Device Regulation (MDR), manufacturers must provide detailed instructions for use (IFU) to guide the proper and safe use of medical devices and products. For specific categories of devices and under certain conditions defined in the Regulation (EU) 2021/2226 (eIFU Regulation), these instructions for use may be provided in electronic form only.

A joint statement co-signed by AESGP was released by several associations proposing a targeted update to the scope of the Regulation (EU) 2021/2226 to encourage a level playing field.

Read the full statement

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