Document paper

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

MedTech Europe, together with 11 organisations, asks the Medical Device Coordination Group (MDCG) to consider the scope extension of Commission Implementing Regulation (EU) 2021/2226 on electronic Instructions for Use (eIFU) a priority for 2024.

Expanding a scope of this regulation via a targeted update will allow for a level playing field, help equity of access to medical devices across the EU and thereby support efficient MDR implementation.

To read more about our ask – allowing all medical devices used by healthcare professionals to be accompanied by IFU in an electronic format – please consult our latest position paper here: Electronic Instructions for Use for all professional use Medical Devices: MedTech Europe calls for scope expansion of EU 2021/2226 – position paper – MedTech Europe

Posted on 05.02.2024