Document paper

Electronic Instructions for Use for all professional use Medical Devices: MedTech Europe calls for scope expansion of EU 2021/2226 – position paper

With the rapid evolution of technology, MedTech Europe believes that the Regulation (EU) 2021/2226 (eIFU Regulation) no longer reflects the generally acknowledged state of the art as called out in the Medical Device Regulation 2017/745 (MDR); Annex I General Requirements, Art.1. Regulation (EU) 2021/2226, even though recently published, only allows for a limited extension of the original legislation EU 207/2012 in terms of scope. It falls short of the needed legislation for a digital era that allows for the use of electronic format Instructions for Use (eIFU) for all professional use medical devices.

Industry has been asked at various instances to provide data from the field which could support any such extension of scope. MedTech Europe conducted a data collection survey among healthcare professionals and other staff working in hospitals, from which clear messages emerged regarding the healthcare sector’s preference for an electronic format IFU.

Therefore, we call on the European Commission and the Member States to amend the Regulation (EU) 2021/2226 to allow for an expanded use of electronic format IFU for all medical devices used by professionals.

Posted on 16.11.2022