Brussels, 2 February 2024
Medical Device Regulation (MDR) requires manufacturers to provide detailed instructions for use (IFU) to guide proper and safe use of medical devices and products. Regulation (EU) 2021/2226 (eIFU Regulation) establishes the conditions under which instructions for use may be provided in electronic form only. Although the eIFU Regulation acknowledges that the provision of instructions for use in electronic form instead of in paper form can be beneficial, its scope is limited to specific categories of devices.
COCIR and other 11 organisations propose a targeted update to the scope of the Regulation (EU) 2021/2226 to encourage a level playing field.
Download statement from Related files